GI Oncology Digest Archive

GI Oncology Digest – September 3, 2026

2026-09-03

• Lancet Digital HealthCopenhagen CAQ Phase 3 cluster-RCT — post-colonoscopy quality feedback lifts ADR 48.6% vs 43.4%, OR 1.24, p=0.032, and adenocarcinoma detection 8.9% vs 6.5%, OR 1.51
• Signal Transduction and Targeted TherapyANCHOR Phase 3 — anlotinib fails noninferiority vs bevacizumab in 1L RAS/BRAF-WT mCRC, mPFS 11.0 vs 11.0 mo, HR 1.00, margin 1.09 not met
• Am J GastroenterolACG Clinical Guideline — new GRADE guidance on adenomatous colorectal polyposis, germline testing selection, endoscopic surveillance and chemoprevention in FAP and MUTYH
• Nature CancerGlutaPanc Phase 1 — L-glutamine plus gem/nab-paclitaxel in treatment-naive advanced PDAC, ORR 44%, mOS 22 mo in just 16 patients vs historical control
• ESMO GI OncologyNeoadjuvant-response meta-analysis — 6600 patients, adjuvant chemo helps partial responders, OS HR 0.64, but not complete responders, OS HR 1.00

GI Oncology Digest – August 31, 2026

2026-08-31

• Am J GastroenterolJ-CAP-C chemoprevention RCT — curcumin missed its primary endpoint in 577 patients but cut recurrent adenomas ≥6 mm, RR 0.56, P=0.04
• Lancet OncologySHR-A2102 Phase 1 — nectin-4 ADC in 395 patients including 77 with oesophageal SCC, grade 3–4 TRAEs 54%
• EndoscopySEMS network meta-analysis — 10 RCTs, 1659 patients, no difference between covered and uncovered stents, with a cholecystitis signal for fully covered
• GastroenterologyCA19-9 CAR T — AbLIFT15.28z kills CA19-9-positive PDAC organoids and murine tumours, preclinical only
• ESMO OpenPan-Asian ESMO guideline — 10 Asian societies adapt the HCC guideline, with voting held independent of drug access

GI Oncology Digest – August 29, 2026

2026-08-29

• Lancet Gastro HepTALENTACE Phase 3 — on-demand TACE plus atezolizumab-bevacizumab extends TACE-PFS 11.3 vs 7.0 mo, HR 0.71, p=0.0089, with OS still immature
• JCODEEPER final analysis — mFOLFOXIRI plus cetuximab beats bevacizumab only in left-sided RAS/BRAF wild-type mCRC, mPFS 14.8 vs 11.9 mo and mOS 50.2 vs 40.2 mo, with no difference overall
• ESMO OpenRATIONALE-306 Phase 3 follow-up — tislelizumab plus chemo holds mOS 19.1 vs 10.0 mo, HR 0.61, at 45 months in PD-L1 TAP-high oesophageal squamous cancer
• JHEP ReportsHAIC plus atezolizumab-bevacizumab Phase 2 — primary ORR endpoint missed at 45.7% vs 28.6%, p=0.095, PFS improved but OS flat
• Clin Cancer ResBotensilimab plus balstilimab Phase 1b — MSS colorectal cancer without active liver metastases, ORR 21% and 36-month OS 33% in 123 patients

GI Oncology Digest – August 27, 2026

2026-08-27

• FDARASONQUE — daraxonrasib becomes the first RAS inhibitor approved in metastatic pancreatic cancer, mOS 13.2 vs 6.7 mo, HR 0.40, p<0.0001
• Clinical Cancer ResearchNEST Phase 2 — botensilimab + balstilimab drives a 41% major pathologic response in MMR-proficient colon cancer, the subtype immunotherapy has never reached
• Nature CommunicationsKras plus anti-CTLA4 — daraxonrasib primes pancreatic tumors specifically for CTLA-4 blockade and not PD-1, naming the next combination to test

GI Oncology Digest – August 26, 2026

2026-08-26

• FDAHERIZON-GEA-01 FDA approval — zanidatamab + tislelizumab + chemotherapy approved as first-line therapy for HER2+ gastric, gastroesophageal junction and esophageal adenocarcinoma, median OS 26.4 vs 19.2 mo, HR 0.72, p=0.0043
• FDALabel split by HER2 intensity — zanidatamab + chemotherapy without immunotherapy is restricted to IHC 3+, where median PFS reached 14.2 vs 7.6 mo, HR 0.55, 95% CI 0.43–0.69
• Roche VentanaCompanion diagnostics — PATHWAY anti-HER-2/neu 4B5 and VENTANA HER2 Dual ISH approved the same day, making HER2 scoring the gatekeeper that decides which of the two regimens a patient can receive

GI Oncology Digest – August 25, 2026

2026-08-25

• Lancet OncologySTAR-TREC Phase 2/3 — chemoradiotherapy beats short-course RT for rectal organ preservation, 12-mo TME-free survival 78.5% vs 60.6%
• Lancet OncologyIfebemtinib + Garsorasib Phase 1b/2 — FAK plus KRAS G12C blockade in mCRC, ORR 38.9% vs 16.7% but the randomised difference missed significance
• ESMO OpenCRLM Response Heterogeneity — one well-responding liver metastasis lifts 3-year OS to 56.4% vs 43.4% across 705 resected nodules
• ESMO OpenCodeBreaK 101 Phase 1b — sotorasib plus panitumumab and FOLFIRI in KRAS G12C mCRC, ORR 56.5% and mOS 17.9 mo
• Clinical Cancer ResearchEMB-01 Phase 1b/2 — EGFR/c-MET bispecific in heavily pretreated mCRC, confirmed ORR 12.5% overall and 20.7% in left-sided RAS/RAF wild-type

GI Oncology Digest – August 22, 2026

2026-08-22

• LancetTALENTOP Phase 3 — first randomised test of conversion surgery after atezolizumab + bevacizumab in HCC with macrovascular invasion, time to treatment failure 20.4 vs 11.8 mo, HR 0.60
• Annals of OncologySKYSCRAPER-07 Phase 3 — anti-TIGIT adds nothing after definitive chemoradiation in oesophageal SCC and the primary endpoint was missed, but atezolizumab alone carries a descriptive OS signal, HR 0.69
• ESMO OpenPaclitaxel oral solution Phase 3 — an oral taxane beats IV paclitaxel on overall survival in second-line gastric cancer, 9.13 vs 6.54 mo, HR 0.770, with less neuropathy and alopecia
• JAMA OncologyCRC mortality disparities — 3,110 US counties over 2000-2019, a 16-fold spread between counties and mortality still rising under age 45
• Clinical Cancer ResearchUltrasensitive ctDNA MRD — every one of 14 oesophageal recurrences was ctDNA-positive before relapse, 59% of positives below the limit of first-generation assays

GI Oncology Digest – August 20, 2026

2026-08-20

• Annals of OncologyESMO Express Update — daraxonrasib is now written into the metastatic pancreatic cancer guideline, ten weeks after RASolute 302 reported mOS 13.2 vs 6.7 mo and HR 0.40
• Nature MedicineLiON prospective AI trial — 10,333-patient single-arm trial of an added AI reader for liver malignancy, AUC 0.952, and 15 malignancies flagged that had been overlooked
• MHRABGB-B2033 Innovation Passport — UK regulator fast-tracks a hepatocellular carcinoma biologic, with no efficacy data yet disclosed
• Clinical Cancer ResearchFGFR2b proteogenomics — MD Anderson finds FGFR2b is the dominant FGFR2 isoform in 88.6% of biliary tract cancer and a tractable surface target in iCCA
• GastroenterologyWNT immune evasion — APC or CTNNB1 activation, not RNF43 loss, licenses BRAF-mutant colorectal transformation by shutting down CCL20

GI Oncology Digest – August 18, 2026

2026-08-18

• JCOASCO Living Guideline v2026.1.2 — the first-line decision tree for advanced gastroesophageal cancer gets its scheduled rewrite, with HER2, PD-L1 and MSI status now the axis the whole algorithm turns on
• Clinical Cancer Researchγδ T-cell signature — baseline circulating and intratumoral γδ T cells predict response to atezolizumab–bevacizumab in HCC, a signal absent under sorafenib and reproduced in MSI-high colorectal cancer

GI Oncology Digest – August 15, 2026

2026-08-15

• Clinical Cancer ResearchPembrolizumab + GM-CSF Phase 2 — first test of a myeloid-directed cytokine added to PD-1 blockade in advanced biliary cancer misses its efficacy bar at ORR 12%, but two complete responses and on-treatment CD8+ expansion mark out who the strategy might still serve
• Clinical Cancer ResearchPancreatic adenosquamous multi-omic atlas — a 178-patient clinical cohort, a 244 vs 29,021 genomic comparison and Visium spatial profiling show ASQ shares KRAS with PDAC yet carries higher MTAP loss, enriched MSI-high/PD-L1+/TMB-high biology and immune infiltrate that tracks the squamous compartment

GI Oncology Digest – August 13, 2026

2026-08-13

• Nature MedicineDaraxonrasib acquired resistance, phase 1/2 ctDNA correlative — first genomic map of how RAS multi-selective inhibition fails in pancreatic cancer: treatment-emergent RAS-pathway alterations in 59% of patients, mutant KRAS amplification in 36%, and no acquired secondary KRAS mutations at all
• EBioMedicineCCA risk-prediction models — machine learning on 487,495 UK Biobank participants stratifies future cholangiocarcinoma risk from 5-10 routine parameters, AUROC 0.71 to 0.80 across four external cohorts totalling more than 9 million patients

GI Oncology Digest – August 12, 2026

2026-08-12

• J Natl Cancer InstSimpleScreen CRC FDA approval + PREEMPT CRC census-adjusted analysis — first cfDNA blood test approved on a 48,000-person prospective screening cohort, CRC sensitivity 81.1% but advanced precancerous lesion sensitivity only 13.7%
• CA Cancer J ClinACS colorectal screening guideline update 2026 — blood tests formally ranked second-line, recommended only for people who decline or fail to complete a preferred stool or endoscopic test
• CMS National Coverage DeterminationColoSense Medicare coverage — stool-RNA test covered for ~65M beneficiaries at 93% CRC and 45% advanced adenoma sensitivity
• International Journal of CancerBlood-based ctDNA screening systematic review — across 20 asymptomatic-population studies no ctDNA assay yet matches FIT, best early-stage sensitivity 71-85%
• JCO Precision OncologyCOSMOS-CRC prospective cohort — Shield in 451 patients gives 87.9% CRC sensitivity but 37.0% for advanced precancerous lesions

GI Oncology Digest – August 11, 2026

2026-08-11

• Annals of OncologyCheckMate 648 Phase 3 5-year — first-line nivolumab combinations hold their OS advantage in advanced oesophageal squamous cancer at 5 years, OS HR 0.62 in PD-L1≥1% for both nivo+chemo and nivo+ipi
• Cancer CellMountain-02 Phase 2 RCT — tumour-specific MHC class II status selects who benefits from perioperative tislelizumab in gastric cancer, major pathological response 61.8% vs 26.5%
• Lancet Gastroenterology & HepatologyDENEB diagnostic accuracy study — a 39-miRNA blood test detects 81% of advanced adenomas and 91% of colorectal cancers, AUC 95%
• GutLynch syndrome surveillance cohort — 4,732 English MMR carriers show lower mortality with ≤3-year colonoscopy but no fall in CRC incidence, and a rise at ≤2 years
• The OncologistNEO-Nal-IRI Phase 2 — neoadjuvant NALIRIFOX in pancreatic cancer meets its safety endpoint with a 10% major complication rate and 90% R0 resection

GI Oncology Digest – August 9, 2026

2026-08-09

• FDAOlomorasib Breakthrough Therapy designation — first regulatory recognition of a KRAS G12C inhibitor in previously treated advanced pancreatic cancer, on Phase 1/2 LOXO-RAS-20001 data, in a niche with no approved targeted option
• JCO Precision OncologySPACE-FLOT registry — peritoneal relapse is 41% of all recurrences after perioperative FLOT and the earliest and deadliest pattern, post-recurrence survival 4.4 vs 9.8 mo
• Clinical Cancer ResearchCLDN18.2 spatial immune atlas — tumour-infiltrating B cells, not tertiary lymphoid structures, mark reduced checkpoint-inhibitor benefit in CLDN18.2-high gastric cancer across 103 patients and CheckMate 649
• GutCirculating EV checkpoints — PD-1/PD-L1/CTLA-4 on serum extracellular vesicles flag immunotherapy resistance in HCC 36-42 weeks before imaging does

GI Oncology Digest – August 6, 2026

2026-08-06

• JAMASOLARIS Phase 3 — high-dose vitamin D3 added to first-line chemotherapy plus bevacizumab does not improve progression-free survival in metastatic colorectal cancer, mPFS 11.8 vs 10.3 mo, 1-sided p=0.25, and overall survival 25.6 vs 27.0 mo
• Clinical Cancer ResearcheRapa Phase 2 — encapsulated rapamycin is safe in familial adenomatous polyposis and intermittent dosing cut duodenal polyp burden by 33.3% at 6 months, p=0.04, sending the every-other-week schedule to phase III
• Clinical Cancer ResearchLOKON002 Phase 1/2b — the intratumoral CD40/4-1BB oncolytic vector LOAd703 plus gemcitabine produced a 35% objective response rate confined entirely to first-line pancreatic cancer, with Th1 immune activation in the tumour microenvironment at week 13

GI Oncology Digest – August 4, 2026

2026-08-04

• JCOPRODIGE-24/CCTG PA6 genomic ancillary — first molecular readout of the adjuvant PDAC standard: mFOLFIRINOX beat gemcitabine only in KRAS-mutant tumours, and HRR status was not predictive
• HR 0.58, 95% CI 0.34–0.98ONS randomized secondary analysis (Asia Pac J Clin Nutr) — three months of oral nutritional supplements after colorectal resection halved chemotherapy modifications (17.5% vs 35.1%, p=0.01) and cut 5-year all-cause mortality
• Cancer MedicineIORT meta-analysis — 25 studies and 2,664 patients show intraoperative radiotherapy improves local control in advanced or recurrent colorectal cancer with no excess anastomotic leak
• Future OncologyNedaplatin/paclitaxel CRT Phase 2 — single-arm neoadjuvant chemoradiotherapy in ESCC reaches pCR 30.3% in 33 resected patients, with FOXP3 and TIGIT flagged as hypothesis-generating biomarkers

GI Oncology Digest – August 1, 2026

2026-08-01

• Lancet OncologyARISTOTLE Phase 3 — adding irinotecan to capecitabine chemoradiotherapy in high-risk locally advanced rectal cancer fails on disease-free survival while nearly doubling grade ≥3 toxicity
• JAMA OncologyTORCH Phase 3 — adding selective thermal ablation to TACE in unresectable BCLC-B hepatocellular carcinoma more than doubles median PFS and halves the hazard of death, mPFS 17.7 vs 7.3 mo, HR 0.47
• ESMO OpenDESTINY-PanTumor02 subgroup — trastuzumab deruxtecan delivers a 22.0% response rate in HER2-expressing biliary tract cancer but only 4.0% in pancreatic, with 17.1% ILD in the biliary cohort
• Annals of OncologyCOCA deep learning — noncontrast CT AI detects colorectal cancer at 88.2% sensitivity and 99.5% specificity across 27,433 consecutive real-world patients

GI Oncology Digest – July 30, 2026

2026-07-30

• JCOFIND Phase 3 — ctDNA methylation-guided surveillance doubles curative-intent salvage after resected colorectal cancer, 48.1% vs 23.6%, RR 2.03, with a 3.9-month detection lead time but no survival readout yet
• JCOCOMMIT Phase 3 — NRG-GI004/SWOG-S1610 reaches full publication, FOLFOX/bevacizumab plus atezolizumab beats atezolizumab alone in first-line dMMR/MSI-H mCRC with PFS HR 0.439 and ORR 86.1% vs 46% at 46-month follow-up

GI Oncology Digest – July 28, 2026

2026-07-28

• HR 0.739STELLAR 5-Year Update Phase 3 (JCO) — short-course radiotherapy-based total neoadjuvant therapy gives a durable overall survival edge over long-course chemoradiotherapy in locally advanced rectal cancer, 5-yr OS 78.1% vs 69.7%
• AstraZenecaCLARITY-Gastric01 Phase 3 — sonesitatug vedotin becomes the first anti-CLDN18.2 antibody-drug conjugate to significantly improve overall survival in 2L+ CLDN18.2-positive advanced gastric/GEJ/esophageal cancer on topline, PFS not met and quantitative data pending
• JCOPANCprAId — a histology-based deep-learning biomarker predicts differential benefit from adjuvant gemcitabine vs mFOLFIRINOX in resected pancreatic cancer, externally validated in the randomized PRODIGE-24/PA6 trial, treatment-interaction p=.003 for DFS

GI Oncology Digest – July 26, 2026

2026-07-26

• PFS HR 0.61, OS HR 0.42DeFianCe Phase 2 (Clin Cancer Res) — anti-DKK1 sirexatamab + bev/chemo misses PFS in all-comer 2L mCRC (9.2 vs 8.3 mo, HR 0.84) but DKK1-high patients benefit
• Gastric CancerAustrian dMMR/MSI-H GEA — real-world n=55, doublet immunotherapy drives 100% pCR and supports non-operative management in resectable gastroesophageal cancer
• p=0.033Neo-STAR Phase 2 (Cancer Communications) — adding tislelizumab to short-course-RT total neoadjuvant therapy in rectal cancer lifts pCR 45.3% vs 27.6% (p=0.052) and MPR 50.9% vs 31.0%
• J HepatolABC System — 27-center, 1,307-patient preoperative score for perihilar cholangiocarcinoma separates 5-yr OS 35% vs 11% and 90-day mortality 6% vs 21%
• adjusted HR up to 6.50New-Onset Diabetes Cohort (Gut) — 402,663-person 15-year study links diabetes severity and rapid escalation to pancreatic cancer risk

GI Oncology Digest – July 24, 2026

2026-07-24

• JCOTNTCRT Phase 3 — intensified doublet total neoadjuvant therapy beats standard chemoradiotherapy in high-risk locally advanced rectal cancer, 3-yr DFS 74.8% vs 66.0% and pCR 26.4% vs 9.8%
• JCOCHALLENGE Cost-Utility — structured exercise after adjuvant chemo for colon cancer is dominant vs health education, saving $1,589/patient while adding 0.10 QALYs
• HR 0.61ASCOLT Translational Study + Meta-Analysis (eBioMedicine) — adjuvant aspirin gave no significant DFS benefit within ASCOLT for PIK3CA-mutant or COX-2-high CRC, but a pooled 3-trial meta-analysis found fewer recurrences in PIK3CA exon 9/20 mutants
• Nature CommunicationsCopanlisib + Nivolumab Phase 1/2 — PI3K inhibitor plus anti-PD-1 fails to meet ORR in microsatellite-stable colorectal cancer regardless of PIK3CA status

GI Oncology Digest – July 21, 2026

2026-07-21

• FDAPelareorep Fast Track — oncolytic reovirus + checkpoint inhibitor earns FDA Fast Track for previously-treated anal squamous-cell carcinoma, GOBLET ORR ~30% vs 13.8% historical and 12-mo OS 82% vs 45.7%
• J Gastrointest CancerMSI-H mCRC Meta-Analysis — pooled KEYNOTE-177 + CheckMate-8HW confirm first-line immunotherapy as standard, PFS HR 0.61 and OS HR 0.77 consistent across all subgroups

GI Oncology Digest – July 19, 2026

2026-07-19

• Cancer DiscoverymKRAS-VAX Phase 1 — first-in-human 6-mutation KRAS peptide vaccine for pancreatic cancer interception in hereditary-risk carriers, mutant-KRAS-specific T-cell response in 18/20, durable to 2 yr, 0/20 progressed to PDAC over median 16.5 mo
• Clin Cancer ResGCC CAR-T Phase 1 — first efficacy signal for GUCY2C-targeted CAR-T in refractory metastatic CRC, ORR 33% and DCR 63% but responses brief with 2 treatment-related deaths
• BMJ Open GastroenterolHCC Surveillance NMA — 170 studies and 62,643 patients: ultrasound sensitivity 0.34 is no better than AFP for very-early HCC, contrast-enhanced MRI least stage-dependent
• Nat CommunIL-26 Mechanism — nuclear IL-26 from tumor-specific Th17 cells epigenetically reprograms colorectal tumors to drive checkpoint-blockade resistance, nominating a druggable resistance target

GI Oncology Digest – July 17, 2026

2026-07-17

• The OncologistZanidatamab Pooled Analysis — reconstructed cross-trial IPD in 1L HER2+ metastatic gastric/GEJ suggests zanidatamab regimens outperform the KEYNOTE-811 pembrolizumab standard — but it is not a randomized head-to-head
• FDAPD-L1 IHC 28-8 pharmDx — companion-diagnostic approval identifying ESCC, gastric, GEJ, and esophageal adenocarcinoma patients eligible for nivolumab, based on CheckMate-648 and CheckMate-649
• Annals of OncologyDeepComp Multimodal AI — deep-learning model predicts post-gastrectomy complications and independently prognosticates survival across 11 centers, lifting mean surgeon sensitivity from 47% to 88%
• LNM 5%LND Meta-Analysis (J Gastrointest Cancer) — 40 studies and 5,872 patients: routine lymph node dissection improves staging and survival in intrahepatic and perihilar cholangiocarcinoma (LNM 37-39%, OS HR 2.0-2.5) but not HCC

GI Oncology Digest – July 15, 2026

2026-07-15

• Gut & LiverDAA-HCC Meta-Analysis — 88 studies and 8,839 HCC patients: direct-acting antivirals achieve 89% SVR and independently cut recurrence and all-cause mortality, settling the old worry that curing hepatitis C fuels tumor recurrence
• Int J Radiat Oncol Biol PhysKCSG CO 14-03 7-Year RCT — adding consolidation CAPOX after preoperative chemoradiation for locally advanced rectal cancer lifts 7-year DFS numerically but not significantly, at a transient quality-of-life cost
• Int J Radiat Oncol Biol PhysMEND-IT Phase 2 — neoadjuvant FOLFOXIRI plus chemoradiation is feasible in high-risk locally advanced rectal cancer, with 82% completing all six cycles and grade 3-or-worse events in 37%
• GastroenterologySOX9-SPEM Axis — SOX9 is the master switch that drives gastric chief cells into pre-cancerous metaplasia, and deleting it blocks KRAS-driven gastric carcinogenesis in mice, nominating a chemoprevention target

GI Oncology Digest – July 14, 2026

2026-07-14

• Lancet Gastro HepatolCaPP3 Phase 3 RCT — low-dose aspirin for Lynch syndrome cancer prevention, n=1,879: 100 mg was non-inferior to 600 mg in ITT with far fewer serious bleeds, while 300 mg was not
• GastroenterologyHBsAg-Seroclearance Cohort — territory-wide Hong Kong study of 13,379 patients defines who can safely stop HCC surveillance after hepatitis B functional cure, annual HCC incidence 0.03% in non-cirrhotic patients who cleared before age 50
• Clinical Cancer ResearchH63D-PDAC Biomarker — the germline HFE H63D variant is enriched in resectable pancreatic cancer yet independently predicts shorter disease-free survival, p=0.002, via a TWIST1-driven EMT program
• Nature CommunicationsNrf2-Treg Axis — regulatory T cells switch on Nrf2 to survive the lactate-rich liver-tumor microenvironment, and high Nrf2-Treg activation tracks with shorter PFS on atezolizumab/bevacizumab
• GastroenterologyCholangiocarcinoma Subtypes — a state-of-the-art molecular map showing surgical anatomy does not equal biology and making the case for upfront FGFR2/IDH profiling in every biliary cancer

GI Oncology Digest – July 11, 2026

2026-07-11

• Nature MedicineHRS-4642 Phase 1b/2 — first-in-class IV KRAS-G12D inhibitor + gemcitabine/nab-paclitaxel drives a confirmed ORR 63.3% in treatment-naive KRAS-G12D-mutant metastatic pancreatic cancer
• JAMA OncologyTOPAZ-1 4-year post hoc — durvalumab + gem/cis sustains a long-term OS edge in advanced biliary tract cancer, mOS 13.0 vs 11.4 mo, HR 0.75, 48-month OS 11.8% vs 4.3%
• Cell Host & MicrobeCRC microbiome meta-analysis — 6,779 samples across 27 studies define a universal, diet-modifiable gut-microbiome signature for colorectal cancer, nearly identical in early- vs late-onset disease

GI Oncology Digest – July 9, 2026

2026-07-09

• Lancet OncologyPERISCOPE II Phase 3 — gastrectomy + cytoreduction + HIPEC adds no survival over systemic therapy in gastric cancer with limited peritoneal metastases and triples serious toxicity, closing early for futility
• EMADaraxonrasib phased review — CHMP fast-tracks EU assessment of the pan-RAS inhibitor in previously-treated metastatic pancreatic cancer, the first EU regulatory step off the RASolute 302 Phase 3
• Cancer DiscoveryPreoperative Vitamin D RCT — high-dose vitamin D remodels the stage I-III colon cancer immune microenvironment, raising CD8+ memory T cells and cutting Tregs in a randomized window trial
• Annals of MedicineSurufatinib Phase 2 — adding surufatinib to 2L doublet chemo shows an encouraging signal in mCRC while the triplet backbone proves too toxic

GI Oncology Digest – July 7, 2026

2026-07-07

• Annals of OncologyJUPITER-06 Phase 3 — final OS analysis confirms toripalimab + chemo sustains survival in advanced ESCC, mOS 17.7 vs 12.9 mo, and a genomic scheme out-predicts PD-L1
• J Hematol OncolCLDN18.2 CAR-T Phase 1 — durable long-term control of peritoneal metastases in advanced gastric cancer
• J Gastrointest CancerEsophageal perioperative meta-analysis — perioperative chemotherapy vs preoperative chemoradiotherapy in resectable esophageal carcinoma
• J Gastrointest CancerProCore EUS-FNB meta-analysis — reverse-bevel needle improves sampling of solid pancreatic masses

GI Oncology Digest – July 5, 2026

2026-07-05

• 18% vs 40%COMPETE Phase 3 (Lancet) — [177Lu]Lu-edotreotide beats everolimus in advanced progressive GEP-NETs, mPFS 23.9 vs 14.1 mo (HR 0.67, p=0.022) with far fewer grade 3-4 toxicities
• JCOeNRGy Phase 2 — zenocutuzumab is the first targeted signal in NRG1 fusion-positive cholangiocarcinoma, ORR 36.8%, mPFS 9.2 mo
• JAMA OncologyCIRCULATE-Japan GALAXY — ctDNA MRD after resection of colorectal liver metastases identifies who benefits from adjuvant chemo and who can be spared
• J Gastrointest CancerAnal SCC EGFR meta-analysis — Moffitt-led pooled analysis of cetuximab/panitumumab in advanced anal squamous-cell carcinoma, ORR 52%, mOS 11.9 mo

GI Oncology Digest – July 2, 2026

2026-07-02

• p=0.014PICC-2 Phase 2 (Lancet Oncology) — neoadjuvant toripalimab + celecoxib beats toripalimab alone in dMMR/MSI-H locally advanced CRC, pCR 89% vs 69%
• HR 0.85, p=0.28CAIRO6 Phase 3 (Lancet Oncology) — perioperative systemic therapy adds no OS benefit over upfront CRS-HIPEC in resectable colorectal peritoneal-only metastases, mOS 44 vs 39 mo
• p<0.001PORTAL Phase 3 (BMJ) — robotic pancreatoduodenectomy non-inferior to open, faster functional recovery 12.1 vs 16.0 days
• JAMA OncologySEPT9_CROSS — circulating methylated SEPT9 outperforms AFP for early HCC in cirrhosis, AUROC 0.79 vs 0.71, BCLC 0-A sensitivity 74.5% vs 23.5%

GI Oncology Digest – June 30, 2026

2026-06-30

• MedCCA therapeutic sequencing — 32-trial network meta-analysis positions durvalumab + GemCis as the 1L standard while genotype-matched therapy cuts progression risk vs FOLFOX, FGFR inhibitors post ORR 35-42% and ivosidenib IDH1 PFS HR 0.37 — a case for upfront genomic profiling in every advanced biliary cancer
• JCOGLP-1 receptor agonists in cancer care — review synthesizes epidemiologic and mechanistic evidence that GLP-1RAs may lower obesity-related GI-cancer risk and aid perioperative metabolic optimization, mapping insulin, inflammation, angiogenesis and immune pathways across tumor types
• J Gastrointest CancerEsophageal perioperative therapy — 8-RCT meta-analysis finds preoperative chemoradiotherapy improves R0 resection and pathologic complete response vs perioperative chemotherapy but yields no overall survival or PFS difference, with a squamous-cell subgroup signal favoring CRT

GI Oncology Digest – June 29, 2026

2026-06-29

• AstraZenecaEnhertu EU approval — European Commission clears trastuzumab deruxtecan as the first tumor-agnostic HER2-directed therapy in the EU for previously treated HER2+ solid tumors, including colorectal and pancreatic, on DESTINY-PanTumor02/Lung01/CRC02
• J HepatolHbA1c trajectories & liver events — territory-wide cohort of 294,096 patients with type 2 diabetes links rising HbA1c to more liver-related events including HCC, while rapid glycemic improvement mitigates risk
• EndoscopyCADe surveillance colonoscopy — population-based RCT finds AI detection adds nothing to adenoma detection overall and helps only lower-performing endoscopists
• Cancer DiscoveryTumor microbial burden — MD Anderson and MSKCC show intratumoral microbes drive interferon signaling and checkpoint-blockade response in colorectal and gastric cancer, highest in dMMR tumors
• Clin Exp MetastasisTOPAZ-1/KEYNOTE-966 safety meta — pooled analysis of 1,754 advanced biliary-tract patients confirms adding a checkpoint inhibitor to chemotherapy does not raise overall adverse-event risk

GI Oncology Digest – June 27, 2026

2026-06-27

• n=57Disitamab vedotin + tislelizumab + S-1 Phase 2 (JCO) — chemo-free-light 1L combo in HER2-overexpressing advanced gastric/GEJ posts ORR 89.5%, mPFS 13.8 mo and a striking mOS 31.9 mo
• ESMO OpenVery early-onset mCRC genomics — patients 30-39 yr show worse survival than 40-49 yr with KRAS enrichment and more peritoneal spread
• 31.9 vs 16.4 mo, HR 0.506Neoadjuvant therapy in resected iCCA (Ann Surg Oncol) — Mayo cohort (n=343) links NAT to nearly doubled post-recurrence OS
• Clin Cancer ResBTC molecular determinants — MSK profiling of 1254 biliary cancers finds 32% carry level 1/2 actionable alterations, but targeted therapy improves PFS without an OS gain
• IRR 0.59HCC prevention meta-analysis (BMC Gastroenterol) — antiviral therapy cuts HCC risk 40% in non-cirrhotic chronic hepatitis B

GI Oncology Digest – June 25, 2026

2026-06-25

• 51% lower risk of deathBREAKWATER (EC approval) — European Commission clears encorafenib + cetuximab + FOLFOX as the first BRAF-targeted 1L regimen for BRAF V600E metastatic CRC, on a Phase 3 OS benefit
• HR 1.60Biological aging & EOCRC (Nature Medicine) — UK Biobank (n=154,169) ties accelerated biological aging to early-onset solid cancers, with adipose-tissue aging linked specifically to early-onset CRC
• 3-yr DFS HR 0.98, p=0.93Adjuvant SOX±RT Phase 3 (JAMA Network Open) — adding radiotherapy to adjuvant SOX after D2 gastrectomy fails to improve DFS or OS in 620 patients
• OncoimmunologyMEDITREME + METIMMOX pooled Phase 2 — 1L chemoimmunotherapy improves OS in MSS mCRC, with baseline CD8 TILs as a candidate selection biomarker
• Signal Transduct Target TherNab-paclitaxel + S-1 Phase 2 — induction chemo in locally advanced pancreatic cancer hits 71% 6-month PFS and converts 18% to surgery

GI Oncology Digest – June 19, 2026

2026-06-19

• FDAGivastomig Fast Track — novel CLDN18.2 × 4-1BB bispecific wins FDA Fast Track in 1L HER2-negative metastatic gastric/GEJ, given with nivolumab + chemo in CLDN18.2+/PD-L1+ tumors, registrational Phase 3 expected Q4 2026
• HR 1.24, p=0.53Anti-EGFR maintenance vs stop-and-go (ESMO Open) — IPD pooled analysis of 4 RCTs (n=378) in left-sided RAS/BRAF-wt mCRC finds equivalent OS for treatment de-escalation, 26.3 vs 29.7 mo
• Eur J CancerCONTROL NETS Phase 2 — first RCT of Lu-DOTATATE PRRT + CAPTEM in pancreatic NETs, ORR 72.2% vs 33.3% and 27-mo PFS 61.1% vs 33.3%, but no benefit in small-bowel NETs
• GutdMMR immune escape — mouse-plus-human study shows MSI-H CRC evades immunity through dual immunoediting + local immunosuppression, explaining immune-rich yet progressive tumors
• GutExtrinsic lipids in CRC — dietary arachidonic-acid-rich fatty acids are absorbed from the gut lumen and accumulate in right-sided colorectal tumors, and blocking fatty-acid import or β-oxidation curbs proliferation

GI Oncology Digest – June 17, 2026

2026-06-17

• J HepatolHCC primary refractoriness — international multicohort study defines a myeloid-driven immunosuppressive phenotype behind early failure of 1L atezolizumab+bevacizumab — primary-refractory mOS 7.3 vs 31.5 mo, IFN-γ-low + NLR≥3 the strongest predictor
• Clin Cancer ResTelisotuzumab adizutecan Phase 1 — first-in-human c-Met ADC ABBV-400 in 2L+ gastric/GEJ adenocarcinoma, ORR 29% and clinical benefit 71%, responses enriched in MET-amplified/c-Met-high tumors
• Nat CommunmCRC clonal evolution — single-cell whole-genome sequencing of 58 tumoroids from 6 metastatic CRC patients maps chemotherapy-induced mutational trajectories, with extrachromosomal DNA amplification and LINE-1 retrotransposition hitting driver genes under treatment pressure
• GutSPP1+ macrophage–Treg axis — scRNA-seq of CRC tumour-draining lymph nodes identifies an SPP1-CD44-NF-κB1 program driving immunosuppressive CD137+ Treg maturation, and LNP-siSPP1 plus anti-CD44 mAb suppresses nodal metastasis in vivo
• Nat CommunKRAS–interferon necroptosis — oncogenic KRAS activates cGAS-STING-TBK1 type I IFN signaling that primes PDAC for necroptosis, and caspase-8 inhibition selectively kills tumor cells, reducing burden in mouse models and patient-derived organoids

GI Oncology Digest – June 15, 2026

2026-06-15

• ASCO 2026Atebimetinib Phase 2a — MEK 'deep cyclic' inhibitor + modified gemcitabine/nab-paclitaxel posts mOS 17.3 mo in 1L metastatic pancreatic cancer vs 8.5 mo MPACT historical control, ORR 36%, no high-grade atebimetinib-specific toxicity
• J Nucl MedExtrapulmonary NEC DOTATATE PET — Moffitt prospective study finds only 13% of poorly differentiated extrapulmonary neuroendocrine carcinomas show uniform SSTR avidity, challenging routine SSTR-targeted imaging/PRRT in high-grade NEC
• 0.03 vs 0.31, p<0.001EUS-BD vs PTBD (Endoscopy) — prospective 14-center European trial (n=209) in unresectable malignant distal biliary obstruction: EUS-guided drainage beats percutaneous on clinical success (73.5% vs 55.9%) and 30-day reintervention
• J HepatolHFE C282Y Base Editing — in vivo LNP-delivered adenine base editing corrects up to 67% of hepatocytes and reverses hepatic iron overload/fibrosis in hemochromatosis models, an HCC-prevention proof of concept
• EndoscopyGenerative Chromoendoscopy — deep-learning synthetic indigo-carmine imaging improves visibility of early gastric neoplasms vs white light in a 60-patient multicenter study

GI Oncology Digest – June 13, 2026

2026-06-13

• J Clin OncolOrigAMI-1 Phase Ib/II — amivantamab monotherapy shows durable single-agent activity in chemorefractory RAS/BRAF wild-type mCRC, ORR 29% anti-EGFR-naive / 19% after anti-EGFR / 22% right-sided, DoR up to 9.8 mo
• MedPLATIC Phase 2 — sintilimab + lenvatinib + TACE-HAIC converts 77.2% of unresectable HCC to resection, ORR 80.7% by mRECIST, PFS HR 0.55 vs historical control
• MedOPTICAL-2 Phase 2 RCT — adding the PD-1/CTLA-4 bispecific cadonilimab to neoadjuvant mFOLFOXIRI nearly triples pCR vs mFOLFOX6 in pMMR/MSS locally advanced CRC, 26.8% vs 9.8%, OR 3.4

GI Oncology Digest – June 11, 2026

2026-06-11

• J Clin OncolRTOG 0848 Phase 3 — adjuvant gemcitabine ± chemoradiotherapy after pancreatic-head resection misses OS overall but CXRT improves OS and DFS in node-negative patients, n=354
• Lancet Gastroenterol HepatolTESAR Phase 3 — adjuvant chemoradiotherapy vs completion TME after local excision of early rectal cancer, non-inferiority not met for 3-yr local recurrence 5.0% vs 1.1% but stoma rate 2.6% vs 45.4% with far less morbidity, n=197
• Clin Cancer ResFostrox + lenvatinib Phase Ib/2a — liver-targeted prodrug after immunotherapy in 2L HCC, ORR 24%, mOS 13.7 mo with no liver-function deterioration in 21 pts
• MedCommTorHAIC Phase 2 — HAIC + toripalimab vs sorafenib in locally advanced HCC, non-comparative n=72, mOS 20.9 vs 16.4 mo, mPFS 9.1 vs 7.2 mo
• PNASHpRS genomic risk score — bacterial GWAS of 528 H. pylori genomes predicts gastric cancer progression along Correa's cascade, AUC 0.902

GI Oncology Digest – June 9, 2026

2026-06-09

• NEJMINDIGO Phase 3 — obexelimab in IgG4-related disease cuts flares vs placebo, HR 0.44, complete remission 37.1% vs 19.6%, 65% reduction in cumulative glucocorticoid rescue, a steroid-sparing backbone for autoimmune pancreatitis and IgG4 sclerosing cholangitis
• HR 0.79, p=0.107, n=243ALTAIR Phase 3 (Nat Med) — first post-adjuvant MRD-guided RCT in resected CRC reads negative: trifluridine/tipiracil in ctDNA+ patients did NOT improve DFS over placebo, mDFS 9.30 vs 5.55 mo
• Nat MedSYNCHRONIZE-MASLD Phase 3 — survodutide 6mg weekly delivers ≥30% MRI-PDFF liver fat reduction in 84.2% vs 24.3% placebo, weight loss −12.2% vs −1.0%, the most consequential HCC-prevention read in years
• OR 1.22, NCT05888623VHA CADe cluster RCT (Gastroenterology) — real-world AI-assisted colonoscopy across 269 endoscopists / 334,200 colonoscopies raises ADR 50.7% → 54.9% while control sites stayed flat
• GutPancreatic luminal-basal spatial map — spatial transcriptomics across native pancreatic duct + PDAC + ASCP defines a Keratin-5/ΔNp63 basal program preserved in adenosquamous but fragmented in PDAC, with BAS/LUM-B signatures tracking basal-like PDAC and worse survival

GI Oncology Digest – June 7, 2026

2026-06-07

• Ann OncolBREAKWATER Cohort 3 Phase 3 — encorafenib + cetuximab + FOLFIRI nearly halves progression vs FOLFIRI±bev in BRAF V600E 1L mCRC, mPFS 15.2 vs 8.3 mo, ORR 64% vs 39%
• n=20GUCY2C CAR-T Phase 1 (JCO) — first CAR-T to show real activity in heavily pretreated mCRC, DL3 ORR 40%, mPFS 7 mo, no Grade 4/5 CRS
• delay HR 1.35EOCRC treatment delays (JAMA Oncology) — Texas Cancer Registry n=112,672 shows language barriers drive delays and worse OS in early-onset CRC
• Clin Cancer ResKRAS + MTAP co-loss PDAC — MD Anderson/BostonGene n=6,190 genomic landscape defines an 18.9% immune-excluded subgroup with shorter OS
• Cancer DiscovBacteroides fragilis → HCC — gut pathobiont translocates to liver and activates a novel Enolase-Vimentin oncogenic axis along the gut-liver axis

GI Oncology Digest – June 5, 2026

2026-06-05

• mPFS HR 0.25, mOS HR 0.29, n=188KC-WISE Phase III (Ann Oncol) — anbenitamab + chemo in 2L HER2+ G/GEJ nearly quarters progression risk
• 16% vs 6%, OS HR 0.71CheckMate 649 5-year (Ann Oncol) — nivo+chemo triples 5-yr OS in CPS≥5 G/GEJ/esophageal adeno
• 1-yr PFS 71.9%, HR 0.54 vs historicalEC-CRT-002 Phase II (JCO) — short-course tislelizumab + CRT in unresectable ESCC beats maintenance arm
• JCOIMHOTEP Phase II — perioperative pembrolizumab in dMMR/MSI localized CRC delivers 52.7% pCR, 68% after 2 cycles vs 46% after 1
• JAMA Intern MedHepatologist-led palliative care RCT — 19-center cluster RCT shows non-inferiority to PC specialists, higher patient satisfaction

GI Oncology Digest – June 4, 2026

2026-06-04

• EFS HR 0.65 in CPS≥10, p=0.0082ASTRUM-006 Phase 3 (Lancet) — perioperative serplulimab + SOX nearly halves event risk in PD-L1+ resectable gastric/GEJ
• JCOFIGHT-302 Phase 3 — first 1L FGFR2-targeted RCT in cholangiocarcinoma, pemigatinib mPFS 8.3 vs 6.8 mo, ORR 47% vs 15%, but trial closed early as gem/cis/durvalumab became new SoC
• Nature MedicineSavolitinib Phase 2 — MET-amplified heavily pretreated G/GEJ, ORR 32.3%
• Lancet OncologyOCLURANDOM Phase 2 RCT — first head-to-head Lu-DOTATATE vs sunitinib in progressive metastatic pNET, 12-mo PFS 80.5% vs 41.9%
• Sci Transl MedCLDN1 mAb — Llovet/Goyal/Heikenwälder team validates Claudin-1 as a tractable surface target in cholangiocarcinoma across PDX and organoid models.

GI Oncology Digest – June 2, 2026

2026-06-02

• NEJM / ASCO Plenary LBA5RASolute 302 full Phase 3 publication in NEJM — daraxonrasib (pan-RAS(ON) inhibitor) HALVES death risk in 2L KRAS-mutant mPDAC, mOS 13.2 vs 6.7 mo (HR 0.40, p<0.0001), Grade ≥3 AEs 43.6% vs 57.5%
• ASCO 2026EMERALD-3 Phase 3 full ASCO data (LBA4000) — durvalumab + tremelimumab + lenvatinib + TACE quad therapy beats TACE alone on PFS (13.0 vs 9.8 mo, HR 0.70, p=0.0007) in embolization-eligible unresectable HCC
• ASCO 2026CIRCULATE Phase 3 (LBA3500, AIO KRK-0217/ABCSG) — first RCT to prove ctDNA-guided adjuvant chemo delivers benefit in stage II MSS colon cancer: 3-yr recurrence 19% vs 62% (HR 0.23, p=0.009), 3-yr DFS 77% vs 38%, ctDNA-negative patients 87% DFS without chemo
• ASCO 2026PANKU-Esophagus01 / Iza-bren Phase 3 (Abstract 4008) — EGFR/HER3 bispecific ADC izalontamab brengitecan beats chemo in 2L recurrent/metastatic ESCC after PD-1/platinum, mOS 9.8 vs 7.2 mo (HR 0.64, p=0.0004), mPFS 4.2 vs 2.0 mo (HR 0.50), ORR 35.3% vs 13.1%
• JCO / ASCO 2026ONO-4578-08 Phase 2 RCT (JCO + ASCO oral) — EP4 antagonist + nivolumab + chemo in 1L HER2-negative G/GEJ: overall mPFS 9.0 vs 6.9 mo (HR 0.67, p=0.040), PD-L1 CPS≥1 mOS NR vs 12.7 mo (HR 0.44)

GI Oncology Digest – May 29, 2026

2026-05-29

• HERIZON-GEA-01 Phase 3 full primary publication in NEJM (n=914): zanidatamab + tislelizumab + chemo nearly halves disease progression vs trastuzumab + chemo in 1L HER2+ gastroesophageal adeno (mPFS 12.4 vs 8.1 mo, HR 0.63
• NEJMmOS 26.4 vs 19.2 mo, HR 0.72)
• JCOTelisotuzumab adizutecan (Temab-A, ABBV-400) Phase I in heavily pretreated MSS mCRC — c-Met ADC with novel topo-1 payload delivers ORR 15.6%, DCR 74.6%, mPFS 4.6 mo, mOS 10.4 mo (n=122), JCO editorial frames it as a credible MSS-CRC opportunity
• Annals of OncologyTAC01-HER2 Phase 1 — first-in-class T-cell antigen coupler (autologous cell therapy, distinct from CAR-T) in 23 HER2+ solid tumors: 2/9 PRs in gastric/GEJ, DCR 61.1%, no Grade-5 toxicity, CRS in 61%
• J HepatolEASL position paper standardizes preclinical models of MASLD/MASH/HCC — 12-author consensus from DKFZ + Newcastle + Harvard + CUHK proposing harmonized criteria across the SLD → HCC continuum
• GutAutoimmune gastritis is a hidden gateway to cardia, GOJ, and oesophageal cancers — Gut review reframes AIG beyond non-cardia gastric adeno + type-I g-NETs

GI Oncology Digest – May 27, 2026

2026-05-27

• Nature Medicine, Phase 2 NCT04595747Rogaratinib (pan-FGFR inhibitor) hits ORR 41.7% and mPFS 31.0 mo in SDH-deficient GIST — first targeted therapy with real activity in this 10–15% imatinib-refractory subset
• AstraZeneca PR + ASCO 2026 previewEMERALD-3 Phase 3 (durvalumab + tremelimumab + lenvatinib + TACE vs TACE) met PFS in embolization-eligible unresectable HCC — full ASCO LBA4000 data June 1
• Nature CommunicationsRTID machine-learning model halves unnecessary diverting ileostomy after rectal anterior resection (41.3% → 17.7%) with no leak increase in 750-patient multicenter RCT
• 54% vs 36%SWOG S2107 negative randomized Phase 2 (ASCO 2026, n=85): adding nivolumab to encorafenib + cetuximab in previously treated MSS BRAFV600E mCRC did NOT improve mPFS (5.8 vs 6.3 mo, HR 1.10, p=0.64), ORR (35% vs 32%), or mOS (13.5 vs 11.6 mo, HR 0.85, p=0.29) — but doubled Grade 3–4 TRAEs
• Clinical Cancer Researchcirculating tumor fraction (CTF) >30% in mPDAC predicts shorter OS (HR 1.87) and links to basal-like subtype + CDK4/MT2A upregulation in PA.7 correlative

GI Oncology Digest – May 26, 2026

2026-05-26

• LBA5, May 31RASolute 302 — Revolution Medicines topline confirms daraxonrasib (pan-RAS(ON) inhibitor) Phase 3 in 2L mPDAC: mOS 13.2 vs 6.7 mo, HR 0.40, full plenary at ASCO 2026
• Jazz / JCOHERIZON-GEA-01 PD-L1 subgroup analysis selected for ASCO 2026 (Abstract 4010) — zanidatamab + tislelizumab + chemo in 1L HER2+ GEA, building on the Jan 2026 ASCO GI primary
• LBA3500, May 31CIRCULATE Phase 3 selected for ASCO 2026 — ctDNA-guided adjuvant decisions in stage II colon cancer, full results embargoed until presentation
• J Gastrointest CancerNetwork meta-analysis of 11 RCTs (n=8,999) ranks 1L immune-related therapy strategies in advanced gastric cancer — dual-target ICI-chemo > single ICI-chemo, no benefit in CPS<1
• Nature CommunicationsZNF274 loss drives classical→basal subtype switch and CDK7 inhibitor resistance in pancreatic cancer via ZEB1 / HERV dsRNA axis

GI Oncology Digest – May 23, 2026

2026-05-23

• ASCO Annual / PR NewswireIza-bren (EGFR/HER3 bispecific ADC) — Ph3 BL-B01D1-305 positive in 2L recurrent/metastatic esophageal SCC, oral at ASCO 2026
• JAMA OncologyDRAGON-01 Phase 3 RCT — intraperitoneal + IV paclitaxel + S-1 nearly doubles OS to 19.4 vs 13.9 mo (HR 0.67) in gastric peritoneal metastases
• GutPTEN loss drives MHC-I downregulation in MSS CRC via NRF2-dependent autophagy — NRF2 inhibition (ML385) restores surface MHC-I and resensitizes to anti-PD-1
• Cancer DiscoveryAsynchronous PanIN-vs-PDAC epithelium-stroma evolution mapped in donor pancreas tissue — stromal reprogramming (SMA+/LRRC15+/LEF1+ CAFs) is the rate-limiting step from precancer to cancer
• BMC CancerMeta-analysis of 6 RCTs (n=1,460) confirms dual ICI improves ORR over PD-1 mono in dMMR/MSI-H mCRC (OR 1.77) but at the cost of toxicity (OR 1.73), with no consistent OS gain

GI Oncology Digest – May 21, 2026

2026-05-21

• JCOGustave Roussy-led Phase II RCT — adjuvant HAI oxaliplatin + IV LV5FU2 after curative resection of ≥4 CRLM nearly doubles hepatic RFS (25 vs 12 mo, HR 0.63) with a 15-point 5-yr OS gain (62% vs 47%)
• Cancer DiscoveryBHLHE40+ glycolytic senescent-like neutrophils define an angiogenic immunosuppressive niche in CRC liver metastases — Bhlhe40 knockout restores anti-tumor immunity
• Clinical Cancer ResearchCA19-9 ≤7 U/mL practical surrogate for Lewis-negative FUT3-null PDAC, dual-threshold model stratifies 615+308 patients into four prognostic groups
• GutMAIT cell enrichment in Lynch syndrome carriers without CRC vs clonally exhausted CD8 in those with CRC — single-cell mucosal atlas, validated in a murine CRC model
• BMC CancerBLOODTRACC dynamic FBC-trend models for primary-care CRC early detection externally validated in 6.5 million UK patients (c-stat 0.73-0.74) — zero new tests required

GI Oncology Digest – May 20, 2026

2026-05-20

• JCOSCOT 113-month final OS confirms 3 months CAPOX is noninferior to 6 months — but 3 months FOLFOX is NOT
• JCOJCOG0603 long-term: adjuvant mFOLFOX6 after CRLM resection improves DFS but yields NO OS benefit at 7.7-year follow-up
• JCOAlliance N0147 — tissue-free epigenomic ctDNA assay stratifies 2,260 stage III colon cancers (HR DFS 5.03, OS 4.45)
• Annals of OncologyCAVE-2 GOIM Phase II — avelumab adds nothing to cetuximab rechallenge in RAS/BRAF WT mCRC, but ctDNA-guided patient selection works
• Nature CommunicationsHCC multiomics framework defines nine molecular subtypes across 529+807 samples

GI Oncology Digest – May 18, 2026

2026-05-18

• JCOEXTEND Phase II RCT — adding metastasis-directed therapy to standard care cuts PFS HR to 0.54 across 6 oligometastatic histology baskets, with the pancreas basket showing PFS superiority and ctDNA clearance as a survival integrator
• JCOMultinational IPD pooled analysis of 4,913 HCC patients on external-beam RT — median OS 6.8 yr in BCLC-0 and 4.6 yr in BCLC-A, outcomes comparable to resection and ablation
• J Gastrointest CancerPerihilar cholangiocarcinoma meta-analysis — liver transplant beats liver resection for 5-yr OS and DFS in 768 selected patients
• Ann OncolTQB2102 first-in-class HER2 biparatopic ADC Phase I — 38.7% ORR in HER2+ CRC, 40% in HER2+ G/GEJ, 47.2% in HER2-low MBC, ILD 0.5%
• Nat CommunARID3B/RUNX3 axis is a tractable epigenetic switch for CD8+ T-cell exclusion in MSS colorectal cancer

GI Oncology Digest – May 19, 2026

2026-05-19

• Nature CommunicationsDurHope Phase 2 — durvalumab + HAIC-FOLFOX → maintenance durva in HCC with major Vp3/Vp4 portal vein invasion: 1-yr OS 63.3%, mOS 13.9 mo, with snRNA-seq identifying a MECOM+ resistant subcluster
• Clinical Cancer ResearchMD Anderson identifies MUC13 as a theranostic target in colorectal cancer — ~70% of mCRC tissues are MUC13+, 161Tb-MUC13 Auger RPT shows preclinical survival benefit, 89Zr-PET maps target density
• PNASNAT10/ac4C/CHAF1A axis is a druggable epigenetic vulnerability in intrahepatic cholangiocarcinoma — NAT10 inhibition restores HERV9NC-driven innate immunity and stalls iCCA in PDX + orthotopic models
• Nature CommunicationsDKC1 emerges as a WNT-feedback / sphingolipid-driven hub for FOLFOX resistance in CMS2 colorectal cancer — FOLFOX-resistant PDOs respond to DKC1 or WNT inhibitors
• BMC CancerMEND-IT II Phase III protocol launches the first head-to-head FOLFOXIRI-based vs CAPOX/FOLFOX-based total neoadjuvant therapy comparison in 394 high-risk locally advanced rectal cancer patients

GI Oncology Digest – May 16, 2026

2026-05-16

• FDAFDA approves zenocutuzumab-zbco (Bizengri) for NRG1+ cholangiocarcinoma — first targeted therapy in this molecular subset
• Clin Cancer ResKEYNOTE-224 7-year follow-up — 1 in 5 advanced HCC patients alive at 4 years on pembro monotherapy
• Clin Cancer ResMD Anderson + NCDB analysis — ablative RT doubles OS in supermassive (≥10 cm) intrahepatic cholangiocarcinoma
• Clin Cancer ResRATIONALE-213 Phase II — PET-guided adaptive neoadjuvant tislelizumab + chemo or CRT in resectable esophageal SCC
• Clin Cancer ResTIME-PRODIGE-28 correlative — ctDNA clearance after FOLFIRI-cetuximab induction predicts 9.6-month PFS in mCRC

GI Oncology Digest – May 15, 2026

2026-05-15

• Signal Transduction & Targeted TherapyHILL Phase II — FOLFOX-HAIC + lenvatinib + durvalumab in unresectable HCC (n=40) hits ORR 75%, mPFS 15.8 mo, 1-yr OS 97.5% and 17.5% R0 surgical conversion
• European Journal of CancerAIO/IKF ELDERLY Phase II RCT (n=120 frail elderly mCRC) — dose-reduced mFOLFOX7 BEATS aflibercept + 5-FU/LV as 1L: PFS@6 68% vs 46%, mPFS 7.9 vs 5.5 mo, ORR 47% vs 22%, less G≥3 toxicity
• JAMA OncologyUK Biobank n=290,645 PDAC prevention analysis — modifiable risk score hits hardest in genetically high-risk under-60s (HR 1.69 vs 1.20 in ≥70), absolute risk gap 6.1× larger in high-PRS
• ESMO OpenHER2-low gastric/GEJ as a distinct biologic subtype — n=2,007 Yonsei cohort plus n=777 NGS, ICIs deliver greater OS benefit in HER2-low vs null, angiogenesis-pathway enrichment drives worse survival
• Journal of Robotic Surgeryrobot vs laparoscopic distal pancreatectomy updated meta-analysis — 64 studies, n=15,790: lower blood loss, fewer conversions, oncologic equivalence

GI Oncology Digest – May 14, 2026

2026-05-14

• JCO Phase Ia/bMosperafenib — first "paradox-breaker" BRAF inhibitor in 80 BRAFᵛ⁶⁰⁰ solid tumor patients with 79% CRC representation, ORR 24% and mPFS 6.4 mo in CRC, brain-penetrant, no PPE/KA
• Clin Cancer ResPhase II progression-directed RT continued alongside first-line systemic therapy in oligoprogressive HCC delivers mPFS 7.0 mo / ORR 64.7% / 1-yr OS 86.4% across 10 Chinese cancer centers
• Cancer DiscoveryBardelli lab shows MSS-CRC evades immune surveillance via a secretome-driven, glycosylation-dependent program independent of neoantigen load
• J Robot Surgrobotic vs laparoscopic low anterior resection meta-analysis of 82,149 patients confirms lower conversion, 30-day mortality and better complete TME
• Nat Communand a 12-metabolite plasma signature derived from 1,706 samples achieves AUC 0.951 for gastric cancer detection

GI Oncology Digest – May 13, 2026

2026-05-13

• GutEMERALD-3 Phase III — durvalumab + tremelimumab + lenvatinib + TACE significantly improves PFS in embolization-eligible unresectable HCC (AstraZeneca), daraxonrasib full Phase 1/2 publication in 2L KRAS-mutant PDAC (NEJM, 35% ORR / 13.1-mo OS), HER2 discordance between primary and metastatic gastric cancer pooled meta-analysis (Clin Transl Oncol — 13% primary vs 18% mets, 38% lung / 31% liver), 20-year SEER-Medicare analysis showing perioperative chemo cuts mortality in resected CRC liver metastases by 46% (Surgery), and a mechanism for why CLDN18.2 therapy stalls in KRAS-mutant PDAC with a precision rescue strategy

GI Oncology Digest – May 12, 2026 — Cancer Screening Special Edition

2026-05-12-screening

• Cancer Screening Special Edition pulling together five recent papers that, taken together, reshape how we think about GI cancer early detection: NORCCAP 23-year follow-up (Annals of Internal Medicine) shows single-sigmoidoscopy still cutting CRC incidence and mortality in men two decades later, NORDICC 13-year follow-up (Lancet) shows single colonoscopy cuts CRC incidence but mortality benefit remains elusive, REDMOD AI radiomics on standard-of-care CT (Gut, Mayo Clinic) detects occult pancreatic cancer ~475 days pre-diagnosis with sensitivity nearly twofold higher than expert radiologists, abbreviated non-contrast MRI vs ultrasound (Hepatology, NCT05716620) flips HCC surveillance on its head with 94.6% vs 51.4% sensitivity, and a 5-gene blood methylation panel (Clinical Epigenetics) achieves AUC 0.96 for gastric cancer screening — pointing to a near-future where modality and biology converge for organ-specific early detection.

GI Oncology Digest – May 12, 2026

2026-05-12

• GastroenterologyNORCCAP 23-year follow-up — single-sigmoidoscopy screening in 98,654 adults sustains CRC incidence and mortality reduction in men two decades on (Annals of Internal Medicine), Tinengotinib Phase Ib/II — multi-kinase FGFR/JAK/VEGFR/Aurora inhibitor delivers 30.8% ORR monotherapy and 66.7% ORR in FGFR2-fusion cholangiocarcinoma progressing on prior FGFR inhibitor (Nature Communications), Non-contrast abbreviated MRI vs ultrasound for HCC surveillance — AMRI sensitivity 94.6% vs US 51.4% in 614 paired exams of cirrhotic patients (Hepatology), ASCO Educational Book — Promising new platforms and targets in gastroesophageal cancers, mapping claudin18.2, MET, TROP2, ADCs, bispecifics and CAR-T into the perioperative and advanced GEC algorithm (ASCO Educational Book), Neutrophil-driven trogocytosis in PDAC liver metastases restrains immunosuppressive macrophage polarization — intravital imaging + scRNA-seq mechanistic study reveals a new immunotherapy lever

GI Oncology Digest – May 11, 2026

2026-05-11

• Communications MedicinePOD1UM-303/InterAACT-2 final analysis — retifanlimab + carbo-paclitaxel becomes the first IO-based 1L SOC for advanced squamous anal cancer, mOS 32.8 vs 22.2 mo (HR 0.75, p=0.0305) (Annals of Oncology), NORDICC 13-year colonoscopy screening RCT in 84,583 adults — CRC incidence RR 0.81 ITT / 0.55 per-protocol but mortality not statistically reduced (Lancet), NEOSUMMIT-01 3-yr follow-up of perioperative toripalimab + chemo in locally advanced gastric/GEJ cancer — 3-yr EFS 74.7% vs 56.2% (HR 0.51) and 3-yr OS 81.3% vs 72.2% (HR 0.45) (J Clin Oncol), Mosperafenib paradox-breaker BRAF inhibitor Phase Ia/b in V600E solid tumors (n=80, 63 CRC) — ORR 24.2%, CRC mPFS 6.4 mo with sustained ≥90% pERK inhibition (J Clin Oncol), C-cubed Phase 3 in Japan — sequential vs upfront oxaliplatin in 1L mCRC delivers identical mOS (27.2 vs 27.4 mo, HR 1.00) but lower early treatment burden

GI Oncology Digest – May 7, 2026

2026-05-07

• Daraxonrasib first-in-class RAS(ON) inhibitor — full Phase 1-2 results land in NEJM (Wolpin et al., n=168 PDAC
• Hepatology2L G12 mut ORR 35%, mOS 13.1 mo) on the heels of positive Phase 3 RASolute 302 (OS 13.2 vs 6.7 mo, HR 0.40), Perioperative NALIRIFOX nITRO Phase II long-term — mOS 32 mo ITT, 48 mo resected, TNF-α and germline DDR variants stratify outcomes (ESMO Open), SILENSES Phase II expansion of sintilimab+lenvatinib conversion → surgery in unresectable HCC — 56% conversion, 5-yr OS 73.9% in resected (Signal Transduction & Targeted Therapy), Integrated perioperative host-response optimization Phase III RCT in low rectal cancer — 24-mo DFS 92.8% vs 77.3%, OS 95.9% vs 83.5% (HR 0.39) (Surgery), BSA-adjusted bevacizumab dosing in Atezo/Bev for HCC (n=1507) — Target BBI 106–121% yields mPFS 10.3 vs 6.5 mo, mOS 24.9 vs 19.2 mo

GI Oncology Digest – May 6, 2026

2026-05-06

• Communications Biology, n=77RESET-C Phase II in JCO — single-cycle neoadjuvant pembrolizumab in stage I-III dMMR colon cancer (n=85, Denmark): pCR 44%, MPR 57%, 1-year DFS 96%, 0 recurrences, only 11% G3 AEs (Gögenur et al., J Clin Oncol May 5, 2026), Daraxonrasib + GnP first-line metastatic PDAC GI-102 Phase 1/2 — ORR 58%, 6-mo PFS 84%, 6-mo OS 90% (Wolpin/Revolution Medicines, AACR 2026 late-breaking), Matched targeted therapy in advanced BTC — global cohort n=1049 (Mayo + Duke + NCC East + SCRUM-Japan), mOS 23.3 vs 14.7 mo HR 0.57, p<0.0001 (NPJ Precision Oncology), Integrated DNA + RNA profiling in cholangiocarcinoma (n=62) — KRAS-TP53 co-mutation drives 25-month OS gap, Mesenchymal subtype shorter PFS (BMC Cancer), Senescent endothelial-derived extracellular vesicles drive neoadjuvant chemoresistance in CRC via GPX4 transfer

GI Oncology Digest – May 5, 2026

2026-05-05

• Signal Transduction and Targeted TherapyLancet Oncology trio models 17 cancers across 200 countries 1990–2050 — 6 GI sites, 31.5% of cancers die undiagnosed globally, scaling diagnostic/imaging workforce projected to cut cancer mortality 7.6% (Ward et al., Lancet Oncology), Cancer Discovery May cover from the Tuveson lab shows myofibroblasts induce sympathetic neuroplasticity in the PDAC precancer ecosystem (Cancer Discovery), HGCSG 1903 Phase II ramucirumab + docetaxel 2L AGC ORR 25.7% mPFS 3.1 mo mOS 11.5 mo (Gastric Cancer), COLOSOTO/PRODIGE 107 Phase II trial design — sotorasib + panitumumab + 5-FU in frail/elderly unresectable KRAS G12C mCRC (Dig Liver Dis), ENO2-MIF axis drives M2 macrophage polarization in CRC liver mets, pyrithioxin reduces metastatic burden preclinically

GI Oncology Digest – May 4, 2026

2026-05-04

• ESMO Gastrointestinal OncologyTwo paired Lancet Oncology multisociety Delphi consensus papers standardize liver tumor thermal ablation — first international margin assessment framework (A0/A1/A2) and procedural-practice standards including a >100-case credentialing threshold, TNT + sintilimab + IL-2 yields 42.4% pCR in MSS/pMMR locally advanced rectal cancer Phase II (Sig Transduct Target Ther), Bayesian network meta-analysis of 48 RCTs (34,106 patients) ranks 5 commercial AI colonoscopy systems with EndoAngel best for ADR (OR 1.84, Eur J Gastroenterol Hepatol), and a ctDNA-guided framework for stopping ICIs in MSI-H/dMMR mCRC — early discontinuation (<2y) in responders shows no PFS/OS penalty, ctDNA-negative status (~80%) signals very low relapse risk

GI Oncology Digest – May 2, 2026

2026-05-02

• FDA 'safe to proceed' letter authorizing an Expanded Access Program for daraxonrasib in previously treated metastatic PDAC (Revolution Medicines), long-term update of maintenance rucaparib in BRCA1/2 or PALB2-mutant PDAC (JAMA Oncology), first phase I of the c-Met ADC telisotuzumab adizutecan (ABBV-400) in late-line mCRC (JCO), NEJM Clinical Practice review on Barrett's esophagus, and ASCO 2026 Educational Book on immunotherapy in localized CRC.

GI Oncology Digest – May 1, 2026

2026-05-01

• Cancer MedicineEarly-onset CRC exposome risk factors (Nature Medicine), EORTC-ESTRO OligoCare Delphi consensus on metastases-directed therapy endpoints (Lancet Oncology), ERAS-0015 pan-RAS inhibitor delivers 40% ORR in 2L KRAS G12X PDAC (Erasca/OncLive), Fruquintinib + TAS-102 ± SBRT yields mPFS 8.6 mo in 3L+ mCRC Phase II (Cancer Medicine), HAIC + regorafenib + sintilimab doubles OS vs regorafenib alone in MSS/pMMR CRC liver mets

GI Oncology Digest – April 30, 2026

2026-04-30

• Nature MedicineRAS-GTP inhibition (daraxonrasib) extends to KRAS-mutant cholangiocarcinoma with clinical responses (Cancer Cell), FDA Priority Review for zanidatamab + chemo ± tislelizumab in 1L HER2+ GEA mOS 26.4 mo HERIZON-GEA-01 (FDA/Press Release), SPARK agentic AI cancer pathology across 5400+ patients incl. CRC (Nature Medicine), REDMOD AI detects occult pancreatic cancer 475 days pre-diagnosis AUC 0.82 (Gut), Intestinal metaplasia confirmed as the only precursor to esophageal adenocarcinoma

GI Oncology Digest – April 29, 2026

2026-04-29

• STTTPI3Kγ/STING dual targeting overcomes immune suppression in PDAC (Nature Cancer), global CRC burden and early-onset trends (Nat Rev Clin Oncol), JOSD1 metabolic-immune axis in HCC (Gut), TGM2-mediated ferroptosis resistance in gastric cancer (Cell Discovery), MARCO-driven immunosuppression in cholangiocarcinoma

GI Oncology Digest – April 28, 2026

2026-04-28

• BioDrugsLenvatinib + PD-1 benefits GC with abundant immunosuppressive macrophages EPOC1706 correlative (Cancer Immunology Research), CAFs regulate DNA repair in PDAC through NDRG1-mediated R-loop processing Nature Cell Biology, CCNE1 gain = lethal outcome + immune desert in 1273 gastric cancer patients across 6 cohorts (British Journal of Cancer), GPR34 in damage-associated macrophages enhances anti-tumor immunity with surufatinib in PDAC (Signal Transduction and Targeted Therapy), Site-specific genomic markers predict PD-1 response in gastric/GEJ cancer C-CAT registry 912 patients

GI Oncology Digest – April 27, 2026

2026-04-27

• Cancer ScienceAdequate LND improves OS in esophageal cancer pCR after neoadjuvant HR 0.70 meta-analysis (Annals of Surgical Oncology), Pulmonary mets after PDAC surgery mOS 30 mo vs liver 13 mo prognostic hierarchy (Annals of Surgical Oncology), Perioperative chemo completion HR 0.20 for 1-year OS after total gastrectomy (World J Surg Oncol), EOCRC vs LOCRC 5-year survival in 92K patients with distinct prognostic profiles (J Gastroenterol Hepatol), SLC1A3 aspartate transporter promotes CRC via MDM2-p53 and M2 macrophage polarization

GI Oncology Digest – April 26, 2026

2026-04-26

• J NanobiotechnologyMAYA trial spatial immune profiling predicts chemo-IO response in MSS mCRC (Nature Communications), 5-gene liquid biopsy methylation panel AUC 0.96 for gastric cancer screening (Clinical Epigenetics), TUDCA bile acid drives gemcitabine resistance via MAPK in PDAC (Cell Mol Life Sci), AQP1 methylation signature independently predicts CCA prognosis HR 0.32 (Scientific Reports), ATOX1-targeted cuproptosis nanogel overcomes TACE refractoriness in HCC

GI Oncology Digest – April 25, 2026

2026-04-25

• British Journal of CancerNP137 netrin1 antibody + mFOLFIRINOX mOS 16.4 mo in locally advanced PDAC with 23% conversion surgery (Nature), HAI oxaliplatin doubles hepatic RFS after ≥4 CRLM resection in randomized Phase II (JCO), Neoadjuvant toripalimab + CapeOX 25% pCR in EBV+ gastric cancer (Nature Communications), Consolidative camrelizumab 3-year PFS 62.5% in unresectable ESCC (IJROBP), Glissonian vs hilar dissection RCT shows shorter operative time for laparoscopic hepatectomy in HCC

GI Oncology Digest – April 24, 2026

2026-04-24

• EClinicalMedicineHER2-targeted neoadjuvant therapy 75% ORR in early rectal cancer with organ preservation (AACR 2026), BBO-11818 pan-KRAS inhibitor FDA Fast Track in PDAC (FDA/NCT06917079), Pfizer PD-1×VEGF bispecific Phase 3 in 1L mCRC (NCT07222800), Ultima Genomics ppmSeq WGS-based MRD in CRC (AACR 2026), PROACTIF Y90 radioembolization mOS 21.8 mo in HCC

GI Oncology Digest – April 23, 2026

2026-04-23

• Zolbetuximab + FOLFOX + nivolumab CLDN18.2+ gastric cancer mPFS 18 mo (Nature Medicine), Givastomig CLDN18.2 x 4-1BB ORR 77% FDA accelerated path (Phase 1b), Lancet Commission on global HCC burden (Lancet), Amivantamab + chemo durable 1L responses in WT mCRC (OrigAMI-1), Pelareorep FDA Fast Track KRAS-mut MSS mCRC

GI Oncology Digest – April 22, 2026

2026-04-22

• AACRAutogene cevumeran mRNA vaccine 87.5% PDAC responders alive at 6 years (AACR 2026), Daraxonrasib 1L mPDAC ORR 58% combo + RASolute 303 enrolling (AACR 2026), NCCN gastric cancer v2.2026 durvalumab + tislelizumab (Guidelines), DYNAMIC-III ctDNA-guided adjuvant stage III colon cancer (Nature Medicine), BOT/BAL in treatment-refractory HCC

GI Oncology Digest – April 21, 2026

2026-04-21

• AACR 2026ALASCCA aspirin halves recurrence in PI3K-altered CRC (NEJM), T-DXd real-world OS in HER2+ mCRC (AACR 2026), VS-7375 KRAS G12D ORR 52% in PDAC (AACR 2026), RZ-001 RNA-editing in HCC (AACR 2026), Early-onset CRC plenary

GI Oncology Digest – April 18, 2026

2026-04-18

• AACR 2026Bezuclastinib NDA for GIST PEAK Phase III (FDA), VCN-01 VIRAGE oncolytic virus in mPDAC (AACR 2026), Elisrasib next-gen KRAS G12C 89% ORR in CRC (AACR 2026), BOT+BAL 1L MSS mCRC (AACR 2026), STC-1010 first-in-human MSS mCRC

GI Oncology Digest – April 16, 2026

2026-04-16

• FDARomiplostim RECITE Phase III for CIT in GI cancers (NEJM), Elraglusib doubles 1-year survival in mPDAC (Nature Medicine), ESMO 2026 mCRC Guideline update (Annals of Oncology), Daraxonrasib FDA BTD for KRAS G12X PDAC (FDA), Givastomig accelerated approval pathway gastric cancer

GI Oncology Digest – April 15, 2026

2026-04-15

• FDARASolute 302 daraxonrasib OS in PDAC (Press Release), BREAKWATER full FDA approval BRAF mCRC (FDA), AMPLIFY-201 mKRAS vaccine (Nature Medicine), EMERALD-3 IO+TACE in HCC (AstraZeneca), Optune Pax FDA approval LAPC

GI Oncology Digest – April 14, 2026

2026-04-14

• FDARASolute 302 daraxonrasib OS in PDAC (Press Release), EMERALD-3 IO+TACE in HCC (AstraZeneca), Tinengotinib in CCA (Lancet GI Hepatol), MATTERHORN durvalumab EU approval (AstraZeneca), Lirafugratinib Priority Review CCA

GI Oncology Digest – April 12, 2026

2026-04-12

• SAMCO-PRODIGE 54TIGIT+PD-1 dual blockade in gastric/GEJ cancer (Nature Medicine), GRAPE AI gastric cancer screening (Nature Medicine), Setidegrasib KRAS G12D degrader in PDAC (NEJM), TOPGEAR perioperative CRT in gastric cancer (NEJM), ctDNA predicts ICI outcomes in mCRC

GI Oncology Digest – April 10, 2026

2026-04-10

• LancetATOMIC trial adjuvant IO in dMMR stage III colon cancer (NEJM), BREAKWATER encorafenib/cetuximab in BRAF V600E mCRC (NEJM), Setidegrasib KRAS G12D degrader (NEJM), COMMIT triplet in dMMR mCRC (ASCO GI), HERIZON-GEA-01 zanidatamab in HER2+ GEA