Merck announced results from Keynote-407, a pivotal, Phase 3 study evaluating Keytruda , Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC). In this study, the Keytruda plus chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone. This is the first time that a combination of an anti-PD-1 therapy and chemotherapy has significantly extended overall survival in the first-line treatment of patients with squamous NSCLC. These results, which mark the fifth study in advanced NSCLC where KEYKeytruda RUDA has demonstrated an improved survival benefit, will be presented today in an oral session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #105).
Findings from pre-specified exploratory analyses showed an OS benefit regardless of PD-L1 expression, as follows: patients whose tumors did not express PD-L1 ; patients whose tumors had PD-L1 tumor proportion scores (TPS) of 1-49 percent; and patients who had a TPS of greater than or equal to 50 percent. The addition of Keytruda to carboplatin plus paclitaxel or nab-paclitaxel chemotherapy also significantly improved progression-free survival (PFS), with a reduction in the risk of progression or death of nearly half for patients in the Keytruda combination group, compared with chemotherapy alone. A PFS improvement in the Keytruda combination group was observed in patients whose tumors did not express PD-L1; patients with a TPS of 1-49 percent; and patients with a TPS greater than or equal to 50 percent.
“Metastatic squamous non-small cell lung cancer is a difficult-to-treat type of lung cancer,” said Dr. Luis Paz-Ares, study investigator and professor of medicine at the Hospital Universitario 12 de Octubre, Madrid. “In Keynote-407, first-line treatment with Keytruda in combination with traditional chemotherapy significantly improved both overall survival and progression-free survival in these patients, regardless of PD-L1 expression.”
“Keytruda provides a foundation for treatment of non-small cell lung cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “At ASCO 2018, Merck is pleased to share important new first-line data from Keynote-407, which demonstrate a survival benefit with Keytruda plus chemotherapy, as opposed to chemotherapy alone, in patients with metastatic squamous cell pulmonary malignancies.”
As previously announced, data from Keynote-407 have been submitted to the FDA for review.
Filed Under: Drug Discovery