Merck's Keytruda has hit targets in a Phase III trial investigating its safety and efficacy in patients with previously untreated lung cancer, backing its use in the first-line treatment setting.
An independent data monitoring committee has recommended that the trial be stopped and that patients in the placebo arm be offered the opportunity of treatment with Keytruda (pembrolizumab), after the drug came on out top on both progression-free survival (PFS) and overall survival (OS).
The KEYNOTE-024 study, which enrolled 305 patients with treatment-naïve advanced non-small cell lung cancer and high levels of PD-L1, also showed a safety profile for Keytruda consistent with that seen in previously reported studies.
The degree of the Keytruda's benefit was not disclosed at this time, but Merck said it would be sharing the data with both the medical community and regulatory authorities, presumably in the hope of securing an expanded approval for the drug.
Keytruda, a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands to activate the immune system, is currently approved in the US for patients who have already been treated for advanced NSCLC.
The drug is also approved to treat advanced melanoma.