Merck’s immunotherapy Keytruda (pembrolizumab) demonstrated positive results in three different cancers, including lung cancer, melanoma, and mesothelioma, according to presentations at the American Association for Cancer Research (AACR) conference in Philadelphia.
At the cancer research meeting Sunday, Merck presented new Keytruda data, showing an overall response rate (ORR) of 19 percent and a median duration of response exceeding one year in a diverse group of patients with advanced lung cancer. Based on results from the study, known as KEYNOTE-001, Merck said that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the drug for treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The drug has already received Breakthrough Therapy designation for treatment of advanced NSCLC.
“In this study, NSCLC patients whose tumors express PD-L1 in the majority of their cells experienced the highest response rates to Keytruda treatment,” said Roger Perlmutter, president, Merck Research Laboratories. “The results from this study formed the basis for our Breakthrough Therapy designation and our recent FDA submission for advanced NSCLC, and indicate that tumor PD-L1 expression may be a relevant biomarker to identify patients more likely to have higher rates of response to Keytruda in this tumor type.”
Additionally, Merck presented results from a Phase III study comparing Keytruda to Bristol-Myers Squibb’s (BMS) Yervoy (ipilimumab) for the treatment of unresectable advanced melanoma. In the trial, known as KEYNOTE-006, Keytruda was statistically superior to Yervoy for progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). Last month, the company announced that the study would be stopped early based on these positive results.
According to Merck, compared to Yervoy, Keytruda boosted survival without cancer worsening by 42 percent after 6 months and improved OS by more than 30 percent after a year. Among patients treated with Keytruda, roughly 33 percent responded, compared to 12 percent in the Yervoy group. Based on these results, Merck plans to submit a sBLA for Keytruda for the first-line treatment of advanced melanoma in mid-2015.
“Our goal with the Keytruda development program is to help improve long-term disease control and survival for people suffering from a wide range of cancers,” said Dr. Perlmutter. “They KEYNOTE-006 study compared two immunotherapies that target distinct immune checkpoint pathways, PD-1 and CTLA-4. In this study, our anti-PD-1 antibody, Keytruda, improved overall survival by more than 30 percent compared to ipilimumab, an anti-CTLA-4 antibody, in the treatment of advanced melanoma. We look forward to filing these data with the FDA and health authorities around the world.”
Lastly, the company reported results from a study evaluating Keytruda in patients with mesothelioma, a rare but difficult-to-treat cancer of the lining of the lungs, abdomen and other organs. According to the company, in the trial including 25 patients with advanced pleural mesothelioma, early findings show an overall response rate of 28 percent with Keytruda in patients with tumors that expressed PD-L1. Additionally, 48 percent of patients had stable disease, resulting in a disease control rate of 76 percent.
“This unique study is helping to accelerate our understanding of where Keytruda may work in cancers with limited or no treatment options,” said Dr. Roger Dansey, therapeutic area head and senior vice president, oncology late stage development, Merck Research Laboratories. “These early data in advanced pleural mesothelioma reinforce the clinically meaningful results we are seeing with Keytruda across multiple cancers.”
Last updated: 4/20/15; 11:05am EST