Cancer Medicines From Merck, Bristol Myers And BeiGene In Question, As FDA Committee To Discuss Limiting PD-1 Drugs For Stomach Cancer

The FDA will hold an Oncologic Drugs Advisory Committee (ODAC) meeting on September 26 to reevaluate the approvals of checkpoint inhibitors for advanced gastric, gastroesophageal junction adenocarcinoma, and esophageal squamous cell carcinoma.

The current labeling for approved checkpoint inhibitors in this indication reflects broad approvals in the intent to treat patient populations agnostic of programmed death cell ligand-1 (PD-L1) expression.

Also Read: Merck Stops Lung Cancer Study For Keytruda Combo Due To Ineffective Results, Side Effects.

Cumulative data have 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 focus will be on whether these approvals should be restricted based on tumors’ PD-L1 expression.

The review includes existing approvals for Bristol Myers Squibb Co’s BMY Opdivo (nivolumab) and Yervoy (ipilimumab), Merck & Co Inc.’s MRK Keytruda (pembrolizumab), and pending applications for BeiGene Inc’s BGNE Tevimbra (tislelizumab).

FDA would like the Committee’s opinion on the following:

• 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.
• Adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression.

Earlier this year, the FDA approved BeiGene’s Tevimbra as monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. 

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