The American Association for Cancer Research Center for Cancer Clinical Trials enrolled its first patient in a phase 2 trial testing whether targeted drug regimens can let some stomach and esophageal cancer patients skip surgery.
The trial, called AACR-ADOPT-GEA, is the first study sponsored by the AACR Center for Cancer Clinical Trials, which AACR formed in 2023. It targets patients with localized or locally advanced gastroesophageal adenocarcinoma, a group that currently undergoes chemotherapy followed by removal of the stomach or esophagus, according to an Aug. 5 AACR news release.
Patients with stage 2-3 disease will receive treatment matched to their tumor’s biomarkers. Those with HER2-positive tumors will get zanidatamab (Ziihera), tislelizumab (Tevimbra) and chemotherapy. Those with claudin 18.2-positive tumors will get zolbetuximab (Vyloy), tislelizumab and chemotherapy. AACR plans to add more treatment arms as new therapies emerge.
The two-stage trial will first measure how often each regimen produces a pathologic complete response and build a signature to predict which patients respond. In the second stage, patients predicted to respond will skip surgery. Any regimen that spares at least 20% of patients from surgery will advance to further study.
“To date, perioperative studies in patients with GEA have applied a one-size-fits-all approach, with all patients being treated in the same way regardless of the molecular markers their tumors express and all these patients ultimately needing a large surgical procedure to achieve cure. The AACR-ADOPT-GEA study is a departure from this paradigm,” Elena Elimova, MD, co-principal investigator of the trial and a gastrointestinal medical oncologist at the Princess Margaret Cancer Centre in Toronto, said in the release. “Additionally, the adaptive design allows for rapid assessment of novel or targeted therapies in the curative setting, where they can potentially have the most impact.”
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