The US drugmaker Merck & Co's approved Keytruda lung cancer treatment showed promising results in a late-stage study of patients with advanced lung cancer by providing superior overall survival to chemotherapy. Tumors of patients of advanced disease produced a protein called PD-L1 associated with increased risk of the disease.
The U.S. drug maker released a statement saying that its Keynote-010 study, a randomized Phase two-third trial, showed that patients who were taking two different doses of Keytruda (FDA-approved two mg/kg dose and treatment dose of 10 mg/kg given every three weeks) had longer survival compared to those who took docetaxel, the drug widely used for non-small cell lung cancer (NSCLC). The results show that the success of the trial made the researchers meet their primary objective.
Researchers say that patients whose tumors have high levels of PD-L1, a protein linked to increased risk of the disease, had longer survival to chemotherapy without progression of the disease. This drug will be used for patients with metastatic or advanced lung cancer who did not respond to previous treatments.
More detailed data from the study will be provided soon, Merck said, adding that it will ask the U.S. Food and Drug Administration later this year to add the new data to the drug's package insert label.
Upon approval of this drug earlier this month, the trial showed that it shrank the tumor cells of patients who possess faulty PD-L1 by 41 percent with effects lasting for up to nine months. "Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine," FDA spokesperson Dr. Richard Pazdur said when they approved the drug.
"Today's approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug," he added.
Wall Street analysts expect cancer immunotherapies to earn combined annual sales of over $20 billion by 2020.