FDA Advisory Committee votes against risk:benefit profile of first line anti-PD-1 therapy with advanced HER2 -Negative microsatellite stable gastric/gastroesophageal junction (GEJ) adenocarcinoma with a PD-L1 expression of less than 1.1.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10 to 2 with 1 abstention against the risk:benefit profile of PD-1 inhibitors in the first-line treatment of patients with advanced HER2-negative, microsatellite stable (MSS) gastric/gastroesophageal junction (GEJ) adenocarcinoma with a PD-L1 expression of less than 1.1 The vote was preceded by discussion of the following question: DISCUSSION: In patients with HER2-negative microsatellite stable gastric/GEJ adenocarcinoma, does the cumulative data support the use of PD-L1 expression as a predictive biomarker when selecting patients for treatment with PD-1 inhibitors? "My vote was no based upon the preponderance of evidence at this time
I think the risk:benefit ratio is not favorable," Katherine Van Loon, MD, MPH, of the University of California, San Francisco, said following the vote. During the meeting, representatives from Bristol Myers Squibb, Merck Sharp & Dohme, and BeiGene presented data from the phase III CheckMate 649 (NCT02872116), KEYNOTE-859 (NCT03675737), and RATIONALE-305 (NCT03777657) trials, respectively. "My vote was no," Daniel Spratt, MD, of Case Western Reserve University, said following the vote. "Yelena Y. Janjigian MD, [of Memorial Sloan Kettering Cancer Center] said [during the ODAC meeting] the average doctor sees 5 of these [patients] a year, and I'm not sure we want to let those doctors make that decision [for including a PD-1 inhibitor for patients with a PD-L1 expression of less than 1] when these hazard ratios [for overall survival (OS) in these subgroups] are approaching 1, and there are financial and toxicity impacts."
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