Merck & Co says Keytruda shows better results than chemotherapy in Phase III trials for lung cancer
pharmafile | June 17, 2016 | News story | Medical Communications | MSD, Merck & Co, drug trial, keytruda, lung cancer
US drug major Merck & Co (NYSE: MRK) said late-stage trials for its immunotherapy Keytruda (pembrolizumab) to treat advanced non-small-cell lung cancer showed superiority to standard chemotherapy.
Based on the results, an independent data monitoring committee recommended that the trial be stopped and that patients in the chemotherapy arm of the study have the opportunity to receive Keytruda.
Roger Perlmutter, president, Merck Research Laboratories, 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.”
The study enrolled 305 patients with treatment-naïve advanced NSCLC and high levels of the PD-L1 protein, defined as a tumour proportion score of at least 50%.
Merck said the safety profile of Keytruda in the trial was consistent with that observed in previously reported studies in patients with advanced NSCLC.
Keytruda is already available in a number of indications, and is trialling it in other indications such as head and neck cancer. It also recently received its fourth breakthrough therapy designation from the FDA for the treatment of refractory classical Hodgkin lymphoma.
Anjali Shukla
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