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news.A phase 3 trial assessing the use of Merck’s Keytruda (pembrolizumab), in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed high levels of PD-L1, met its primary endpoint.
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The study demonstrated that Keytruda was superior to chemotherapy as measured by progression-free survival (PFS) and overall survival (OS).
Based on the positive results, the independent data monitoring committee has recommended to stop the trial and the patients receiving chemo be offered the opportunity to switch to Keytruda humanized monoclonal antibody.
Merck said the safety profile of antibody in the trial was consistent with that observed in earlier reported studies in patients with advanced NSCLC.
Merck Research Laboratories president Roger Perlmutter said: "We believe that the KEYNOTE-024 results have the potential to change the therapeutic paradigm in first-line treatment of non-small-cell lung cancer.
"We look forward to sharing these data with the medical community and with regulatory authorities around the world."
Keytruda increases the ability of the body’s immune system to help identify and fight tumor cells.
It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that could affect both tumor cells and healthy cells.
Merck is currently advancing five registration-enabling trials for NSCLC with Keytruda as a monotherapy and in combination.