GI Oncology Daily Digest

April 18, 2026 — AACR 2026 Special Edition
Curated by Dr. Allan Pereira — Moffitt Cancer Center

Top 5 Papers

#1
Source: FDA NDA / Cogent Biosciences  |  Authors: Cogent Biosciences  |  Published: April 1, 2026
Score: 13/20 — FDA NDA submission (8) + Phase III (+3) + new SOC (+2)
Cogent Biosciences completed submission of a New Drug Application to the FDA for bezuclastinib in imatinib-resistant or intolerant GIST, based on the Phase 3 PEAK trial. Bezuclastinib + sunitinib achieved median PFS of 16.5 months versus 9.2 months with sunitinib alone (HR 0.50; p<0.0001) and ORR of 46% versus 26% (p<0.0001). The NDA was submitted under FDA's Real-Time Oncology Review (RTOR) program. Bezuclastinib also received Breakthrough Therapy Designation. This selective KIT exon 17 inhibitor addresses the most common secondary resistance mutations seen after imatinib.
Post angle: Bezuclastinib NDA filed for imatinib-resistant #GIST based on PEAK Phase III. mPFS 16.5 vs 9.2 mo (HR 0.50), ORR 46% vs 26%. Breakthrough Therapy + Real-Time Oncology Review. #GIOnc #TargetedTherapy #FDA
#2
Source: AACR 2026 / Theriva Biologics  |  Authors: Theriva Biologics  |  Published: April 17, 2026
Score: 11/20 — AACR presentation (6) + Phase IIb (+2) + survival benefit (+2) + novel mechanism (+1)
Theriva Biologics presented additional data from the VIRAGE Phase 2b trial of VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus, combined with gemcitabine/nab-paclitaxel in newly diagnosed metastatic PDAC at AACR 2026. Patients receiving 2 doses of VCN-01 achieved median OS of 14.8 months versus 11.6 months with chemotherapy alone. Safety was manageable with transient pyrexia and flu-like symptoms. The FDA agreed on a Phase 3 trial design at a Type B End-of-Phase 2 meeting in March 2026. VCN-01 selectively replicates in tumor cells with dysregulated Rb/E2F pathway and expresses hyaluronidase to degrade the tumor stroma.
Post angle: AACR 2026: VCN-01 oncolytic adenovirus + chemo improves OS in frontline mPDAC (14.8 vs 11.6 mo). VIRAGE Phase 2b met all primary endpoints. FDA agreed on Phase 3 design. #PancreaticCancer #AACR2026 #Oncolytics
#3
Source: AACR 2026 Oral / D3 Bio  |  Authors: Raghav K et al. (MD Anderson)  |  Published: April 2026
Score: 10/20 — AACR oral presentation (7) + novel mechanism overcomes resistance (+2) + GI relevance (+1)
D3 Bio presented results of elisrasib, a next-generation KRAS G12C covalent inhibitor with faster target-binding kinetics and reduced susceptibility to resistance, at AACR 2026. In Phase 1a (42 patients), among KRAS G12C inhibitor-naive evaluable patients: ORR was 88.9% in CRC, 75.0% in PDAC, and 66.7% in NSCLC. Elisrasib addresses the key limitation of first-generation KRAS G12C inhibitors (sotorasib, adagrasib) by maintaining GDP-bound state binding despite rapid nucleotide exchange. D3 Bio raised $108M to advance elisrasib into Phase 3 trials.
Post angle: AACR 2026 Oral: Elisrasib — next-gen KRAS G12C inhibitor. ORR 89% in CRC, 75% in PDAC (Phase 1a). Overcomes resistance to sotorasib/adagrasib. Phase 3 coming. #KRASG12C #CRC #PDAC #AACR2026
#4
Source: AACR 2026 Poster / Agenus  |  Authors: Agenus Inc.  |  Published: April 2026
Score: 9/20 — AACR presentation (6) + Phase I in MSS CRC (+2) + colleague engagement (+1)
Agenus presented preliminary data from an investigator-sponsored study of botensilimab (anti-CTLA-4 Fc-enhanced) plus balstilimab (anti-PD-1) in first-line microsatellite stable (MSS) metastatic CRC at AACR 2026. This extends the prior refractory MSS mCRC data that showed sustained efficacy. France has already granted reimbursed compassionate access for BOT/BAL in refractory MSS CRC. The Phase 3 BATTMAN trial (first patient enrolled April 2026) will provide definitive randomized evidence. If confirmed, this could represent the first effective IO regimen in MSS CRC, which accounts for ~85% of all mCRC.
Post angle: AACR 2026: BOT+BAL (anti-CTLA-4 + anti-PD-1) now in FIRST-LINE MSS mCRC. Preliminary data presented. Phase 3 BATTMAN enrolling. Could IO finally work in MSS CRC (~85% of mCRC)? #CRC #MSS #Immunotherapy #AACR2026
#5
Source: AACR 2026 / Brenus Pharma  |  Authors: Brenus Pharma  |  Published: April 14, 2026
Score: 8/20 — AACR presentation (6) + first-in-human novel platform (+1) + MSS CRC relevance (+1)
Brenus Pharma presented first-in-human data from the BreAK CRC001 Phase I/IIa trial of STC-1010, a next-generation in vivo allogeneic immunotherapy built on the Stimulated Ghost Cells (SGC) platform, in first-line unresectable metastatic MSS CRC at AACR 2026. Among 6 patients with median follow-up of 6 months: 100% disease control rate (DCR) by RECIST, no dose-limiting toxicities, and evidence of early immune engagement. The SGC platform uses dead tumor cells to stimulate the patient's immune system without need for cell manufacturing.
Post angle: AACR 2026: STC-1010 first-in-human in MSS mCRC. 100% disease control rate (6 pts), no DLTs. Novel Stimulated Ghost Cell platform — off-the-shelf IO. #CRC #MSS #Immunotherapy #AACR2026

Additional Papers of Interest

  1. OncoDaily — First EU compassionate access for IO in MSS mCRC; botensilimab + balstilimab available outside clinical trials in France.
  2. AACR 2026 Poster — Preclinical data on novel KRAS and ErbB2 targeted agents for GI and other solid tumors.
  3. British Journal of Cancer — Another KRAS G12C inhibitor showing activity in advanced PDAC; expanding the competitive landscape.
  4. AACR — Dedicated RAS-targeted therapies conference with presentations on next-gen KRAS inhibitors, degraders, and vaccines for PDAC and CRC.
  5. FDA NDA Resubmission — Apatinib (rivoceranib) + camrelizumab for 1L unresectable or metastatic HCC; PDUFA date set.
  6. FDA Priority Review — ORR 46.5%, mPFS 11.3 mo in FGFR2 fusion+ CCA from ReFocus trial.
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