GI Oncology Daily Digest

April 14, 2026
Curated by Dr. Allan Pereira — Moffitt Cancer Center

Top 5 Papers

#1
Source: Press Release / GlobeNewswire (Revolution Medicines)  |  Authors: Revolution Medicines  |  Published: April 13, 2026
Score: 15/20 — Phase III press release (6) + Phase III (+3) + new SOC (+3) + survival benefit (+2) + colleague engagement on X (+1)
Revolution Medicines announced positive topline results from the global Phase 3 RASolute 302 trial evaluating daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). In the ITT population, daraxonrasib nearly doubled median overall survival to 13.2 months versus 6.7 months with chemotherapy (HR 0.40; p<0.0001). The drug also demonstrated significant PFS improvement. The FDA granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for KRAS G12-mutant metastatic PDAC. Revolution Medicines plans to submit an NDA under the Commissioner's National Priority Voucher program and present full data at ASCO 2026.
Post angle: BREAKING: Daraxonrasib nearly DOUBLES survival in metastatic #PancreaticCancer (13.2 vs 6.7 mo, HR 0.40). First Phase III to show this magnitude of OS benefit in pretreated PDAC. A historic moment for RAS-targeted therapy. #PancCancer #KRASG12 #RASolute302
#2
Source: Press Release / AstraZeneca  |  Authors: AstraZeneca  |  Published: April 2, 2026
Score: 13/20 — Phase III press release (6) + Phase III (+3) + survival trend (+2) + new combination (+2)
AstraZeneca announced positive Phase III EMERALD-3 results evaluating durvalumab (Imfinzi) plus tremelimumab (Imjudo) combined with lenvatinib and TACE versus TACE alone in 760 patients with embolization-eligible unresectable hepatocellular carcinoma. The quadruplet combination demonstrated a statistically significant and clinically meaningful PFS improvement. An interim OS analysis showed a favorable trend. The STRIDE regimen (tremelimumab + durvalumab) plus TACE without lenvatinib also showed strong PFS and OS trends. Safety was consistent with known profiles of each agent.
Post angle: EMERALD-3 Phase III: Adding durvalumab + tremelimumab + lenvatinib to TACE significantly improves PFS in unresectable #HCC. Building on EMERALD-1, this could reshape locoregional treatment. #LiverCancer #Immunotherapy #TACE
#3
Source: The Lancet Gastroenterology & Hepatology  |  Authors: Javle M et al.  |  Published: February 2026
Score: 12/20 — Lancet family (9) + Phase II (+2) + biomarker-driven (+1)
This multicentre, open-label Phase 2 trial conducted at 32 US centers evaluated tinengotinib (TT-00420) in patients with advanced or metastatic cholangiocarcinoma across four cohorts based on FGFR status: FGFR2 fusions with primary resistance (A1), FGFR2 fusions with acquired resistance (A2), other FGFR alterations (B), and FGFR wild-type (C). Tinengotinib demonstrated meaningful clinical activity in patients whose tumors had progressed on prior FGFR inhibitor therapy, addressing a critical unmet need in the post-FGFR-inhibitor setting for cholangiocarcinoma.
Post angle: New option after FGFR inhibitor resistance in #Cholangiocarcinoma: tinengotinib Phase 2 results in Lancet GI Hepatol show activity across FGFR2 fusion subtypes, including acquired resistance. #BiliaryCancer #FGFR #TargetedTherapy
#4
Source: Regulatory Approval / AstraZeneca (MATTERHORN Phase III)  |  Authors: Janjigian YY et al.  |  Published: April 2026
Score: 12/20 — Regulatory approval (8) + Phase III data (+3) + new SOC in EU (+1)
The European Commission approved durvalumab (Imfinzi) as the first and only perioperative immunotherapy for patients with resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma, based on the Phase 3 MATTERHORN trial. The trial randomized 948 patients to durvalumab plus FLOT chemotherapy versus FLOT alone. Durvalumab plus FLOT demonstrated a 29% improvement in event-free survival, higher pathological complete response rates, and did not compromise surgical outcomes. This establishes a new perioperative standard of care in Europe for early gastric/GEJ cancer.
Post angle: Milestone for #GastricCancer: Durvalumab becomes first perioperative IO approved in EU for resectable gastric/GEJ cancer (MATTERHORN). 29% EFS improvement + higher pCR with durvalumab + FLOT. #UpperGI #Immunotherapy #MATTERHORN
#5
Source: FDA Priority Review / CancerNetwork  |  Authors: Relay Therapeutics  |  Published: March 2026
Score: 12/20 — FDA Priority Review (8) + Phase II data (+2) + survival benefit (+2)
The FDA granted Priority Review to lirafugratinib (RLY-4008) for the treatment of previously treated FGFR2 fusion/rearrangement-positive cholangiocarcinoma, based on the ReFocus Phase 1/2 trial. Lirafugratinib achieved an overall response rate of 46.5% and a median PFS of 11.3 months. Notably, the drug showed activity regardless of prior FGFR inhibitor exposure, including in patients with acquired resistance mutations. The PDUFA target action date is September 27, 2026. If approved, lirafugratinib would represent a next-generation FGFR2 inhibitor for biliary tract cancer.
Post angle: FDA Priority Review for lirafugratinib in FGFR2+ #Cholangiocarcinoma: ORR 46.5%, PFS 11.3 months, and activity even after prior FGFR inhibitor failure. PDUFA Sept 2026. #BiliaryCancer #FGFR #PrecisionOncology

Additional Papers of Interest

  1. FDA Fast Track Designation — ORR 33% vs 10% with standard care in KRAS-mutated, microsatellite-stable mCRC; oncolytic reovirus approach.
  2. FDA NDA Acceptance — PDUFA December 3, 2026 — Multi-kinase inhibitor + anti-PD-L1 combination for refractory mCRC; NDA accepted by FDA.
  3. FDA NDA Resubmission — PDUFA July 23, 2026 — Apatinib (rivoceranib) + camrelizumab for first-line unresectable or metastatic HCC; PDUFA date set.
  4. FDA Approval — Portable noninvasive tumor treating fields device approved alongside chemotherapy; first FDA-approved therapy for LAPC in nearly three decades.
  5. FDA Fast Track Designation — Novel anti-CD36 antibody granted fast track for HCC; first-in-class mechanism targeting tumor lipid metabolism.
  6. Nature Reviews Gastroenterology & Hepatology — International expert consensus on latest CCA developments, biomarker-driven treatment paradigms, and research priorities.
  7. Randomized Clinical Trial — Randomized trial addressing the lack of effective adjuvant treatments for resectable extrahepatic CCA and gallbladder cancer.
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