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.

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

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.

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.

Read Next:

• Bristol Myers-2seventy Bio Halt Phase 3 Trial For Abecma In Newly Diagnosed Myeloma Patients, Speeds Path To Profitability.

Image by PDPics from Pixabay