GI Oncology Daily Digest

April 16, 2026
Curated by Dr. Allan Pereira — Moffitt Cancer Center

Top 5 Papers

#1
Source: New England Journal of Medicine  |  Authors: Wun T, Kloth DD, Anderson CM et al.  |  Published: April 2026
Score: 15/20 — NEJM (10) + Phase III (+3) + new SOC supportive care (+2)
The global Phase 3 RECITE trial randomized 165 patients receiving oxaliplatin-based chemotherapy for GI cancers (75% CRC, 13% gastroesophageal, 12% pancreatic) with chemotherapy-induced thrombocytopenia (CIT) to weekly romiplostim (n=109) or placebo (n=56). The primary endpoint was met decisively: 84% of patients on romiplostim avoided chemotherapy dose modifications due to CIT versus only 36% with placebo. Grade 3+ AEs occurred in 37% vs 22%, mostly attributable to chemotherapy. Thromboembolic events were rare (2% vs 0%). Romiplostim is now the first TPO receptor agonist shown to maintain chemotherapy dose intensity in GI cancers.
Post angle: BREAKING in NEJM: Romiplostim keeps GI cancer patients ON SCHEDULE with chemo. RECITE Phase III: 84% vs 36% avoided dose delays from low platelets. First TPO agonist for chemo-induced thrombocytopenia in GI cancers. #GIOnc #CRC #SupportiveCare #NEJM
#2
Source: Nature Medicine  |  Authors: Munster PN, Lenz H-J, Grippo PJ et al.  |  Published: April 14, 2026
Score: 13/20 — Nature Medicine (9) + Phase II (+2) + survival benefit (+2)
This randomized Phase 2 trial evaluated elraglusib, a first-in-class GSK-3β inhibitor, combined with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in previously untreated metastatic PDAC. Elraglusib/GnP doubled 1-year survival (44% vs 22%) and improved median OS by 2.9 months (10.1 vs 7.2 mo; 38% reduction in risk of death). Exploratory biomarker data revealed 7–40× increases in tumor-infiltrating cytotoxic immune cells, suggesting an immunomodulatory mechanism. The most common Grade 3+ AEs with elraglusib were neutropenia (52% vs 31%) and fatigue (17% vs 5%). A Phase 3 confirmatory trial is anticipated.
Post angle: New in Nature Medicine: Elraglusib DOUBLES 1-year survival in frontline metastatic #PancreaticCancer (44% vs 22%). GSK-3β inhibitor shows immunomodulatory effect with 7-40x increase in tumor-infiltrating immune cells. Phase 3 coming. #PancCancer #PDAC #NatureMedicine
#3
Source: Annals of Oncology  |  Authors: Cremolini C et al. (ESMO Guidelines Committee)  |  Published: April 14, 2026
Score: 12/20 — Annals of Oncology (7) + practice-changing guideline (+3) + clinical impact (+2)
The updated ESMO Clinical Practice Guideline for metastatic CRC was published April 14, 2026. Key updates include: (1) MSI-H/dMMR: nivolumab + ipilimumab recommended first-line, with pembrolizumab as alternative; (2) BRAF V600E: encorafenib + cetuximab + FOLFOX/FOLFIRI now standard first-line based on BREAKWATER data; (3) Third-line: FTD/TPI + bevacizumab preferred; (4) Molecular-driven algorithm emphasized for all treatment decisions. This represents the most comprehensive update to mCRC management guidelines since the integration of immunotherapy and targeted therapy data from recent Phase 3 trials.
Post angle: ESMO 2026 mCRC Guideline update is HERE. Key changes: • 1L MSI-H: Nivo+Ipi preferred • 1L BRAF V600E: Encorafenib+Cetux+chemo • 3L: FTD/TPI+Bev preferred Molecular-driven treatment algorithm is now standard. #CRC #CRCResearch #ESMO #PrecisionOncology
#4
Source: FDA Regulatory Action / OncLive  |  Authors: Revolution Medicines  |  Published: April 15, 2026
Score: 11/20 — FDA action (8) + Breakthrough Therapy Designation (+2) + colleague engagement (+1)
Following the unprecedented Phase 3 RASolute 302 results (mOS 13.2 vs 6.7 mo, HR 0.40), the FDA granted daraxonrasib both Breakthrough Therapy Designation and Orphan Drug Designation for previously treated metastatic PDAC with KRAS G12 mutations. Additionally, daraxonrasib was selected for the FDA Commissioner's National Priority Voucher pilot program, designed to accelerate development of therapies aligned with US national health priorities. Revolution Medicines plans to submit an NDA in 2H 2026 with potential approval under an expedited pathway.
Post angle: FDA grants Breakthrough Therapy + Orphan Drug Designation to daraxonrasib for KRAS G12X metastatic #PancreaticCancer after RASolute 302 (HR 0.40). Also selected for National Priority Voucher program. NDA expected 2H 2026. #PancCancer #KRASG12 #FDA #RASolute302
#5
Source: FDA Regulatory Action / CancerNetwork  |  Authors: NovaBridge Biosciences  |  Published: March–April 2026
Score: 9/20 — FDA regulatory milestone (8) + novel bispecific mechanism (+1)
NovaBridge announced that the FDA aligned on a potential accelerated approval pathway for givastomig, a CLDN18.2×4-1BB bispecific antibody, in first-line HER2-negative, CLDN18.2+, PD-L1+ gastroesophageal cancer. Phase 1b data showed ORR of 77% at 8 mg/kg with median PFS of 16.9 months. NovaBridge dosed the first patient in a global randomized Phase 2 study in February 2026 and plans a registrational Phase 3 trial with ORR as primary endpoint for accelerated approval in Q4 2026. Givastomig represents a novel mechanism targeting tumor cells through conditional T cell activation via 4-1BB signaling.
Post angle: FDA aligns on accelerated approval path for givastomig in CLDN18.2+ #GastricCancer. Phase 1b: 77% ORR, mPFS 16.9 mo. A bispecific antibody targeting CLDN18.2 with conditional 4-1BB T cell activation. Phase 3 coming Q4 2026. #GastricCancer #GEJ #Immunotherapy #CLDN182

Additional Papers of Interest

  1. Press Release / Agenus — First randomized Phase 3 trial of dual IO (anti-CTLA-4 + anti-PD-1) in refractory MSS mCRC; evaluating BOT+BAL vs BSC.
  2. AACR 2026 Abstract — Novel allogeneic immunotherapy using Stimulated Ghost Cells (SGC) platform; favorable safety and early immune engagement in MSS mCRC.
  3. Nature Reviews Gastroenterol Hepatol — Comprehensive review of CCA treatment landscape including next-gen FGFR inhibitors, IDH1 inhibitors, and emerging bispecific antibodies.
  4. JCO / ASCO GI 2026 — Confirmatory supportive QoL data from RECITE trial showing improved patient-reported outcomes with maintained chemotherapy dose intensity.
  5. FDA NDA Resubmission — Apatinib (rivoceranib) + camrelizumab combination for 1L unresectable or metastatic HCC.
  6. NEJM — Phase 3, 1766 pts: Apixaban 2.5 mg noninferior to 5 mg for recurrent VTE in active cancer (2.1% vs 2.8%), with less bleeding (12.1% vs 15.6%). NEJM Safety-Net: general oncology supportive care.
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