Pharmaceutical giant Merck's flagship immunotherapy drug that was just approved by the United States Food and Drug Administration (FDA) shows promise in the overall survival rate among patients suffering from one of the deadliest type of cancer that affects the lungs.
The drug, Keytruda or pembrolizumab, uses the body's own immune system to kill cancer tumors. Though it was already approved for melanoma, FDA regulators requested more detailed data from its latest trial to make certain that it will eventually improve survival rates among lung cancer patients.
The U.S. drug maker released a statement on Monday 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.
"The results from this trial provide part of a growing body of evidence supporting the potential of Keytruda in the treatment of non-small-cell lung cancer," Dr. Roger M. Perlmutter, president, Merck Research Laboratories said in a press release.
"Advancing the standard of care in cancer requires a collaborative effort, and we are grateful to the patients, institutions and caregivers who participated in this study. We look forward to sharing our complete data with the scientific community and with regulatory agencies in the near future," he added.
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.
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.
Lung cancer is one of the leading cause of deaths worldwide. In fact, according to the Centers for Disease Control and Prevention, 210,828 people were diagnosed with lung cancer in the United States in 2012. During that year, 157,423 people died from the said disease.
The National Cancer Institute reports that this year, there are expected 221,200 new cases and 158,040 deaths from lung cancer in the country.
Photo: Yale Rosen | Flickr
