FOR IMMEDIATE RELEASE
October 2, 2015
FDA approval of Keytruda for patients who express PD-L1 could lead to better patient outcomes across lung cancer spectrum
MILWAUKEE, WISCONSIN – The U.S. Food and Drug Administration (FDA) announced the accelerated approval of Merck & Co., Inc.’s drug Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC) in patients whose tumors have progressed after other treatments and express PD-L1. Keytruda was approved along with the first companion diagnostic to detect PD-L1 expression in NSCLC, the PD-L1 IHC 22C3 pharmDx test by Dako North America, Inc. The Society for Immunotherapy of Cancer (SITC) anticipates that the news will strengthen immunotherapy’s position as a mainstay in cancer care by providing a long-awaited option for many patients afflicted with lung cancer.
“Biomarkers are critically important for patient care. Being able to determine who is most likely to derive benefit from immunotherapy allows physicians to make more informed choices about treatment, and reduces the likelihood of needless treatment or toxicity from regimens unlikely to help others,” says SITC President Elect Lisa H. Butterfield, PhD. The FDA approval offers encouragement to SITC who is dedicated to supporting initiatives and task forces dedicated to advancing similar technologies.
Keytruda is a type of immunotherapy that blocks the PD-1 receptor, which is a part of the pathway that prevents T cells from attacking cancer. PD-L1 is a protein that binds to the PD-1 receptor to activate this pathway. The 22C3 pharmDx test measures how many tumor cells are expressing the PD-L1 protein in order to identify patients who would benefit from Keytruda. The FDA approval is based on results from a large clinical trial KEYNOTE-001, a multipart study evaluating Keytruda in naïve and previously-treated patients with advanced NSCLC.
Keytruda was approved based on the results from a subgroup of 61 patients. These patients had advanced NSCLC that had progressed after other therapies and had PD-L1 positive tumors based on the cut-off values from the 22C3 pharmDx test. In this subgroup, the overall response rate to Keytruda was 41%. In addition, most of the patients who did respond to Keytruda had ongoing responses (84%), including 11 patients who had a response 6 months or longer.
The FDA granted Keytruda breakthrough status in 2014, and it received priority review for this indication. Keytruda was approved under the FDA’s accelerated program. This program is designed to approve drugs that treat patients with serious or life-threatening diseases and show an early effect in clinical trials that is deemed likely to predict a clinical benefit. It allows for patients to get earlier access to promising drugs, while further studies are conducted to confirm the preliminary results.
“It’s tremendously exciting to give clinicians a new tool for treating patients with advanced NSCLC,” says KEYNOTE-001 investigator and SITC member Naiyer A. Rizvi, MD. “We lose 160,000 Americans to lung cancer every year and immunotherapies such as Keytruda demonstrate scientific progress in developing new approaches that can hold promise for patients who need it most.”
Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a non-profit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC is comprised of influential basic and translational scientists, clinicians, health care professionals, government leaders and industry professional around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC aims to one day make the word “cure” a reality for cancer patients everywhere.