US regulators are reviewing Merck & Co’s application to include new data on its immunotherapy Keytruda that could expand its use within the non-small cell lung cancer (NSCLC) patient population.
Keytruda (pembrolizumab) is currently indicated in the US for the treatment of patients with metastatic NSCLC whose tumours express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.
The current NSCLC indication, cleared under the accelerated approvals process, was based on tumour response rate and durability of response in patients with PD-L1 expression on 50 percent or more of the cancer cells.
But data from KEYNOTE-010, now filed with the regulator, show superior overall survival for patients taking Keytruda compared to chemotherapy in patients with PD-L1 expression on just one percent or more of the cancer cells.
As per the accelerated approval process, findings from the study were intended to serve as the confirmatory trial for receiving full approval, establishing the clinical benefit by demonstrating improved survival over standard chemotherapy.
Keytruda is a humanised monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. The drug is also indicated in the US for the treatment of patients with unresectable or metastatic melanoma.