FDA Advisory Panel Rejects PD-1 Inhibitors for Gastric and Esophageal Cancers with Low PD-L1 Expression

FDA Panel Decision:
The FDA's Oncologic Drugs Advisory Committee (ODAC) voted against the use of PD-1 inhibitors in patients with gastric and esophageal cancers who have a PD-L1 expression of less than 1%.

Rationale:
The committee cited a lack of overall survival benefit and potential added toxicities in patients with low PD-L1 expression, leading to an unfavorable risk-benefit assessment.

Clinical Trials:
The decision was based on data from several clinical trials, including CheckMate 649, KEYNOTE-859, and RATIONALE-305, which showed limited efficacy of PD-1 inhibitors in patients with low PD-L1 expression.

Previous Approvals:
The FDA had previously approved pembrolizumab (Keytruda) and nivolumab (Opdivo) for certain gastric and esophageal cancers, but these approvals did not specifically address the use of PD-1 inhibitors in patients with low PD-L1 expression.

Future Implications:
The ODAC's decision may impact future approvals of immune checkpoint inhibitors for gastric and esophageal cancers, emphasizing the need for more precise biomarkers and patient selection criteria.