Top Gastrointestinal Cancer News: October 2025

November 5, 2025
Spencer Feldman
Spencer Feldman

Spencer, Assistant Editor of CURE®, has been with MJH Life Sciences since 2024. A graduate of Rowan University with a bachelor's degree in health communication, Spencer manages CURE's Facebook, Instagram and YouTube. He also enjoys spending time with family and friends, hiking, playing guitar and rock climbing.

Long-awaited progress in rectal and gastric cancer research includes a fast track designation and new survival data.

October brought several significant updates in gastrointestinal cancer research and drug development, including progress in rectal and gastric cancers. Here are the most notable FDA designations and clinical findings shaping treatment discussions this month.

FDA Fast Tracks NG-350A for Mismatch Repair-Proficient Locally Advanced Rectal Cancer

The U.S. Food and Drug Administration (FDA) granted fast track designation to NG-350A as a potential treatment for patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC).

The news was shared in a recent announcement from Akamis Bio, the clinical-stage oncology company developing the therapy.

According to the FDA, fast track status helps speed the development and review of drugs for serious conditions that lack effective treatments, with the goal of accelerating access for patients.

Glossary

Glossary:

Hazard ratio (HR): compares the chance of an event happening over time between two treatment groups.

Overall survival (OS): time from treatment start or diagnosis until death from any cause.

“The NG-350A fast track designation from FDA is a recognition of the significant unmet need for new therapies to treat locally advanced rectal cancer (LARC),” said Dr. Oliver Rosen, chief medical officer at Akamis Bio, in a statement included in the news release. “The global incidence of LARC continues to rise, with a particularly alarming increase of this cancer among younger populations. Patients with mismatch repair-proficient tumors account for approximately 90% of LARC cases, and this population has the greatest need for evolution in the standard of care to include treatments that may enable patients to avoid surgical interventions.”

Imfinzi Plus Chemo Improves Survival in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

For patients with resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, combining the anti-PD-L1 monoclonal antibody Imfinzi (durvalumab) with FLOT chemotherapy (5-fluorouracil-leucovorin-oxaliplatin-docetaxel) led to a significant and meaningful improvement in overall survival — defined as how long patients live after starting treatment — compared with placebo plus FLOT.

These results, which applied regardless of pathological findings, were reported in a presentation of phase 3 MATTERHORN trial data at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin.

With a data cutoff of Sept. 1, 2025, the final overall survival analysis in the intention-to-treat population showed a hazard ratio (HR) of 0.78 for the investigational arm versus the control arm, and median OS had not been reached in either group.

A subgroup analysis by demographic and clinical traits also demonstrated consistent overall survival benefits across most key populations. Importantly, similar results were seen whether patients were PD-L1-positive or PD-L1-negative, with both groups showing an HR of 0.79.

Investigators also noted improvements in event-free survival (EFS), the trial’s primary end point, for patients with any level of pathological response and regardless of nodal status as of the data cutoff on Dec. 20, 2024.

FDA OKs Orphan Drug Designation to DPTX3186 Therapy in Gastric Cancer

The FDA has granted orphan drug designation to DPTX3186, an investigational therapy from Dewpoint Therapeutics being evaluated for gastric cancer, according to a company news release.

This is the first time a condensate-modulating therapeutic has received orphan designation, marking a meaningful development in the advancing field of condensate biology. The announcement comes after the opening of an investigational new drug application for DPTX3186.

Orphan drug designation supports the development of treatments for rare diseases that affect fewer than about 200,000 people in the United States.

“The FDA’s decision to grant orphan drug designation to DPTX3186 is an extraordinary validation of both the promise of condensate biology and the importance of our work in gastric cancer,” said Dr. Isaac Klein, chief scientific officer and head of R&D at Dewpoint Therapeutics. “This recognition reflects the agency’s confidence in our mechanism, our science and our shared goal of bringing new hope to patients facing this devastating disease.”

References

  1. “Final overall survival (OS) and the association of pathological outcomes with event-free survival (EFS) in MATTERHORN: A randomised, phase III study of durvalumab (D) plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric / gastroesophageal junction (G / GEJ) adenocarcinoma.” by Dr. Josep Tabernero. Presented at: ESMO 2025 Congress; October 17–20, 2025; Berlin, Germany. Abstract LBA81.
  2. “Assessing durvalumab and FLOT chemotherapy in resectable gastric and gastroesophageal junction cancer;” https://clinicaltrials.gov/study/NCT04592913
  3. “Akamis Bio Receives FDA Fast Track Designation for NG-350A for the Treatment of Mismatch Repair-Proficient Locally Advanced Rectal Cancer,” news release; https://www.akamisbio.com/items/akamis-bio-receives-fda-fast-track-designation-for-ng-350a
  4. “Fast Track,” FDA; https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
  5. “NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer (FORTRESS);” https://clinicaltrials.gov/study/NCT06459869#study-overview
  6. “FDA Grants Orphan Drug Designation to Dewpoint Therapeutics’ DPTX3186 for the Treatment of Gastric Cancer,” by Dewpoint Therapeutics. News release; Oct. 29, 2025.
  7. “Dewpoint Therapeutics Announces an Open IND for First-in-Class Condensate Modulator DPTX3186 for Wnt-Driven Cancers,” by Dewpoint Therapeutics. News release; Oct. 21, 2025.

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Related Content:

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FDA Grants Orphan Drug Designation to DPTX3186 Therapy in Gastric Cancer
Imfinzi Plus Chemo Improves Survival in G/GEJ Adenocarcinoma