An immunotherapy drug tested on non-small cell lung cancer patients proved so effective in a recent clinical trial that the study has been cut short and the drug is being fast-tracked for approval from the Food and Drug Administration.
Merck, based in Kenilworth, N.J., developed Keytruda, an immunotherapy drug that helps cancer patients' T cells recognize and attack cancer cells growing in the lungs.
In August 2014, researchers at the University of California, Davis introduced a study of Keytruda involving 305 cancer patients. Last week, Merck ended the Phase III clinical trial early, stating that the study proved the drug's effectiveness at lengthening progression-free survival and overall survival compared to standard chemotherapy.
"They would not have done that if the results were not very impressive," said David Gandara, MD, director of the thoracic oncology program at UC Davis. "We know that it's positive, and it will undoubtedly now make immunotherapy the first line of treatment for patients with metastatic lung cancer."
The FDA approved Keytruda for lung cancer treatment in 2015, but only as a follow up treatment if chemotherapy fails. Many physicians prefer immunotherapy over chemotherapy as the treatment is more targeted to cancer cells and better tolerated by patients.
Merck plans to file for label expansion of the drug as soon as possible.
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