MSD's Keytruda/chemo combo nabs EU approval in first-line metastatic squamous lung cancer

MSD’s anti-PD-L1 therapy Keytruda (pembrolizumab) has been awarded marketing authorisation in Europe for the first-line treatment of adult patients with metastatic squamous non-small cell lung cancer (NSCLC) when used in combination with carboplatin and either paclitaxel or nab-paclitaxel, it has emerged.

Phase 3 data submitted in support of the application illustrated that the combo “significantly improved overall survival (OS)”, reducing risk of death by 36% compared to chemotherapy alone regardless of a patient’s PD-L1 tumour expression status.

“In KEYNOTE-407, first-line treatment with Keytruda in combination with chemotherapy resulted in significant improvements in overall survival for patients with metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression,” said Dr Luis Paz-Ares, Chair of the Medical Oncology Department, Hospital Universitario Doce de Octubre in Spain. “Lung cancer is the leading cause of cancer death in Europe, so this approval marks an important milestone for the patients and families facing this difficult-to-treat type of lung cancer.”

Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer at MSD, also remarked: “Keytruda provides a foundation for the treatment of lung cancer in Europe, and this approval expands our first-line combination indications to include adults with metastatic squamous non-small cell lung cancer. This is a meaningful treatment advance as an anti-PD-1 combination therapy is now approved in Europe for this type of non-small cell lung cancer. With this approval, more patients with non-small cell lung cancer may have the opportunity to benefit from combination therapy with Keytruda.”

Matt Fellows