September 26, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

At this meeting, during the morning session the Committee will discuss the use of immune checkpoint inhibitors in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. The current labeling for approved checkpoint inhibitors in this indication reflect broad approvals in the intent to treat patient populations agnostic of programmed death cell ligand-1 (PD-L1) expression. Cumulative data has shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in this patient population; however, clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity. The FDA would like the Committee’s opinion on the: adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population, differing risk-benefit assessments in different subpopulations defined by PD-L1 expression, and adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression. The Committee will discuss the existing supplemental biologics license application (sBLA) 125554/S-091 for OPDIVO (nivolumab) injection, submitted by Bristol Myers-Squibb Company, and sBLA 125514/S-143 for KEYTRUDA (pembrolizumab) injection, submitted by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. which were approved for patients with previously untreated HER2-negative unresectable or metastatic gastric or gastroesophageal adenocarcinoma, and BLA 761417 for tislelizumab injection, submitted by BeiGene USA, Inc. for the same proposed indication.
o During the afternoon session the Committee will discuss the use of immune checkpoint inhibitors in patients with metastatic or unresectable esophageal squamous cell carcinoma. The current labeling for approved checkpoint inhibitors in this indication reflect broad approvals in the intent to treat patient populations agnostic of programmed death cell ligand-1 (PD-L1) expression. Cumulative data has shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in this patient population; however, clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity. The FDA would like the Committee’s opinion on the: adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population, differing risk-benefit assessments in different subpopulations defined by PD-L1 expression, and adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression. The Committee will discuss the existing sBLA 125514/S-096 for KEYTRUDA (pembrolizumab) injection, submitted by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc and sBLAs 125554/S-105 and S-106 for OPDIVO (nivolumab) injection, and sBLA 125377/S-122 for YERVOY (ipilimumab) injection, submitted by Bristol Myers-Squibb Company. which were approved for patients with previously untreated unresectable or metastatic esophageal squamous cell carcinoma, and the new BLA 761380 for tislelizumab, submitted by BeiGene USA, Inc. for the same proposed indication.