US regulators have approved MSD’s Keytruda, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

With this decision, Keytruda (pembrolizumab) is now the first anti-PD-1 approved for first-line treatment of squamous NSCLC regardless of PD-L1 expression, significantly expanding the drug’s treatment scope.

The approval was based on data from the pivotal Phase III KEYNOTE-407 trial, which showed that the drug in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone.

“The results that support this approval from the KEYNOTE-407 trial demonstrate the potential of Keytruda in combination with chemotherapy in patients with squamous non-small cell lung cancer, regardless of PD-L1 expression,” commented Balazs Halmos, director of the multidisciplinary thoracic oncology program at the Montefiore Einstein Center for Cancer Care and director of clinical cancer genomics at the Albert Einstein College of Medicine.

“With this important approval, more patients will have the opportunity to benefit from immunotherapy.”