On Thursday, 26 September, the FDA's Oncologic Drugs Advisory Committee will discuss the use of immune checkpoint inhibitors in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
The FDA notes that 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.
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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 review includes existing approvals for Bristol Myers Squibb Co's (NYSE:BMY) Opdivo (nivolumab) and Yervoy (ipilimumab), Merck & Co Inc.'s (NYSE:MRK) Keytruda (pembrolizumab), and pending applications for BeiGene Inc's (NASDAQ:BGNE) Tevimbra (tislelizumab).
In a briefing document, the FDA indicated that combining immune checkpoint inhibitors (ICIs) with standard chemotherapy does not seem to offer benefits for patients with PD-L1 expression below 1%. Patients with PD-L1 levels of 10% or higher experience the most significant benefit.
The advantages remain unclear for those with PD-L1 levels between 1% and 10%, and interpreting the data is difficult.
Given that patients with low or absent PD-L1 expression are unlikely to benefit, administering anti-PD-1 therapy may introduce risks, including severe immune-related adverse effects, which can further diminish the quality of life in individuals already dealing with malignancy.
"Although these results are exploratory ... strong evidence does not appear to support the use of anti-PD-L1 drugs in patients with low PD-L1 expression," the FDA said.
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