Patients and doctors received news this week of the FDA’s approval of the immunotherapy drug pembrolizumab in combination with platinum doublet chemotherapy as first-line therapy for all patients with non-small cell lung cancer, irrespective of patients’ tumor PD-L1 status.
The new approval follows the FDA’s decision last November to approve pembrolizumab as a first-line therapy for some patients with non-small lung cancer, but only if their tumors showed expression of a protein called PD-L1. The previous approval was based on an international trial led by the Kimmel Cancer Center’s Julie Brahmer, M.D.
This week’s approval was based on a small clinical trial of 160 patients, led by Corey Langer, M.D., director of thoracic oncology and professor of medicine at the University of Pennsylvania. The trial showed that the chemo-pembrolizumab combination can improve the response rates (meaning some evidence of tumor shrinkage) in more than 50 percent of patients with lung cancer compared with nearly 30 percent who received chemotherapy alone. There was a small average benefit of four months — referred to as a progression-free survival benefit — for patients who received the combination compared with those who received only chemotherapy.
However, there was no overall survival benefit of the drug combination. “Immunotherapy, at this point, doesn’t benefit all patients, and we need to be mindful of the drug’s costs and potential side effects,” says Benjamin Levy, M.D., clinical director of medical oncology and medical director of thoracic oncology for the Johns Hopkins Kimmel Cancer Center at Sibley Memorial Hospital in northwest Washington, D.C. “This new drug approval provides a broader opportunity to consider the role of immunotherapy in the treatment of all of our patients with advanced non-small cell lung cancer.”
Watch a video of Levy: A Mission to Lead.