GI Oncology Daily Digest

April 15, 2026
Curated by Dr. Allan Pereira — Moffitt Cancer Center

Top 5 Papers

#1
Source: Press Release / 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) + X colleague engagement (+1)
Revolution Medicines announced positive topline results from the global Phase 3 RASolute 302 trial of daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). Daraxonrasib nearly doubled median OS to 13.2 months versus 6.7 months with chemotherapy (HR 0.40; p<0.0001), with significant PFS improvement. The FDA granted Breakthrough Therapy and Orphan Drug Designation for KRAS G12-mutant PDAC. Full data will be presented at ASCO 2026, and Revolution Medicines plans to submit an NDA under the Commissioner's National Priority Voucher program.
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: FDA Full Approval / AACR  |  Authors: Tabernero J et al.  |  Published: Q1 2026
Score: 14/20 — FDA approval (8) + Phase III data (+3) + new SOC (+3)
The FDA converted the accelerated approval of encorafenib plus cetuximab to full (regular) approval as first-line therapy for BRAF V600E-mutant metastatic colorectal cancer, based on confirmed overall survival data from the Phase 3 BREAKWATER trial. The trial demonstrated median OS of 30.3 versus 15.1 months (HR 0.49; p<0.001) and PFS of 12.8 versus 7.1 months (HR 0.53). This solidifies encorafenib/cetuximab + chemotherapy as the definitive first-line standard of care for this aggressive CRC subtype.
Post angle: Now official: Encorafenib + cetuximab receives FULL FDA approval for 1L BRAF V600E #mCRC based on BREAKWATER OS data (30.3 vs 15.1 mo). From worst prognosis to manageable disease. #CRC #CRCResearch #PrecisionOncology #BRAFV600E
#3
Source: Nature Medicine  |  Authors: Wainberg ZA et al.  |  Published: 2026
Score: 12/20 — Nature Medicine (9) + Phase I novel mechanism (+1) + biomarker-driven (+1) + colleague engagement (+1)
Final results from the Phase 1 AMPLIFY-201 trial evaluated ELI-002 2P, a lymph node-targeted amphiphile vaccine carrying mKRAS peptide antigens, in 25 patients (20 PDAC, 5 CRC) with minimal residual disease after standard treatment. At median follow-up of 19.7 months, 71% of patients developed both CD4+ and CD8+ T cell responses. Patients with strong mKRAS-specific T cell responses had significantly longer radiographic relapse-free survival and overall survival (median OS 28.9 months). Remarkably, 67% of patients exhibited antigen spreading to personalized tumor antigens not present in the vaccine.
Post angle: A cancer VACCINE for KRAS-mutant tumors? AMPLIFY-201 Phase 1 final results in Nature Medicine: mKRAS vaccine induces strong T cell responses in PDAC/CRC patients, with median OS of 28.9 months in responders. #PancCancer #CRC #CancerVaccine #Immunotherapy
#4
Source: Press Release / AstraZeneca  |  Authors: AstraZeneca  |  Published: April 2, 2026
Score: 11/20 — Phase III press release (6) + Phase III (+3) + survival trend (+2)
AstraZeneca announced positive Phase III EMERALD-3 results evaluating durvalumab plus tremelimumab combined with lenvatinib and TACE versus TACE alone in 760 patients with embolization-eligible unresectable HCC. The quadruplet combination demonstrated statistically significant 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.
Post angle: EMERALD-3 Phase III: Adding durvalumab + tremelimumab + lenvatinib to TACE significantly improves PFS in unresectable #HCC. Locoregional + systemic combination showing promise. #LiverCancer #Immunotherapy #TACE
#5
Source: FDA Approval / ACS Bulletin  |  Authors: Novocure  |  Published: Q1 2026
Score: 11/20 — FDA approval (8) + novel mechanism (+2) + clinical impact (+1)
The FDA approved Optune Pax, a portable noninvasive tumor treating fields (TTFields) device, for the treatment of locally advanced pancreatic cancer alongside chemotherapy. This represents the first FDA-approved therapy specifically indicated for locally advanced pancreatic cancer in nearly 30 years. TTFields deliver alternating electrical fields that disrupt rapidly proliferating cancer cells while minimizing damage to healthy tissue, offering a new non-pharmacological treatment modality for this challenging disease.
Post angle: Historic FDA approval: Optune Pax is the first therapy approved for locally advanced #PancreaticCancer in nearly 30 years. Tumor Treating Fields + chemo — a non-pharmacological approach enters the GI oncology toolkit. #PancCancer #TTFields #FDA

Additional Papers of Interest

  1. FDA Fast Track Designation — Oncolytic reovirus: ORR 33% vs 10%, mPFS 16.6 vs 5.7 mo, mOS 27 vs 11.2 mo in KRAS-mutated MSS mCRC.
  2. Lancet Gastroenterol Hepatol — Javle M et al. — Activity in FGFR2-fusion CCA after prior FGFR inhibitor resistance; 32 US centers, four FGFR-status cohorts.
  3. FDA Priority Review — PDUFA September 27, 2026 — ORR 46.5%, mPFS 11.3 mo in FGFR2 fusion/rearrangement+ CCA; active after prior FGFR inhibitor exposure.
  4. EU Regulatory Approval — AstraZeneca — First perioperative IO in EU for gastric/GEJ cancer; MATTERHORN Phase 3: 29% EFS improvement, higher pCR.
  5. FDA NDA Resubmission — PDUFA July 23, 2026 — Apatinib (rivoceranib) + camrelizumab for 1L unresectable or metastatic HCC; PDUFA date set.
  6. FDA NDA Acceptance — PDUFA December 3, 2026 — Multi-kinase inhibitor + anti-PD-L1 for refractory mCRC.
  7. FDA Fast Track Designation — Novel anti-CD36 antibody targeting tumor lipid metabolism; first-in-class mechanism for HCC.
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