FDA to Reassess Checkpoint Inhibitors for Stomach Cancer Based on PD-L1 Expression

FDA Meeting:
The FDA has scheduled a meeting of the Oncologic Drugs Advisory Committee (ODAC) on September 26, 2024, to discuss the use of immune checkpoint inhibitors in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

Focus on PD-L1 Expression:
The meeting will focus on whether the approvals of these drugs should be restricted based on PD-L1 expression levels. PD-L1 expression appears to be a predictive biomarker of treatment efficacy in these patient populations.

Drugs Under Review:
The committee will review existing approvals for drugs like Merck’s Keytruda (pembrolizumab), Bristol Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab), and a new application for BeiGene’s Tevimbra (tislelizumab).

Clinical Trials:
Clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity. The FDA seeks the committee’s opinion on the adequacy of PD-L1 expression as a predictive biomarker and the risk-benefit assessments in different subpopulations defined by PD-L1 expression.

Impact on Treatment:
The outcome of this meeting could lead to changes in how these drugs are approved and used in the treatment of stomach cancers, potentially tailoring treatments more closely to individual patient profiles based on PD-L1 expression levels.