New data for Merck’s Keytruda suggests that the immunotherapy can improve survival in patients with advanced non-small cell lung cancer (NSCLC) who expressed PD-L1, potentially allowing the company to update the drug’s label.
Although the drug, which was originally approved for melanoma, was approved by the FDA for NSCLC earlier in October, the regulator requested more detailed data and the label was not allowed to say that an improvement in survival had been established.
In a statement the company says that the Phase II/III KEYNOTE-010 study found that both the approved 2mg/kg dose and an investigational 10mg/kg does given every three weeks improved overall and survival compared to the standard chemotherapy treatment docetaxel. Both doses also led to high progression-free survival in patients with high levels of PD-L1.
Merck says it will ask the reveal the full results of the study “in the near future” and will be asking the FDA to add the new data to Keytruda’s label later in the year.