MSD’s anti-PD-1 therapy Keytruda has been approved for use in combination with carboplatin and either paclitaxel or nab-paclitaxel for first-line treatment of adults with metastatic squamous non-small cell lung cancer (NSCLC).
Clearance of the treatment in this setting comes on the back of data from the Phase III KEYNOTE-407 trial, which showed that it significantly improved overall survival (OS) in adults with metastatic squamous NSCLC regardless of PD-L1 tumor expression status, reducing the risk of death by 36 percent compared to chemotherapy alone.
“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,” noted Dr Luis Paz-Ares, chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, 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.”
In NSCLC, Keytruda is also approved in Europe for first-line treatment of metastatic non-squamous NSCLC in combination with pemetrexed and platinum chemotherapy in adults whose tumors have no EGFR or ALK positive mutations; first-line treatment of metastatic squamous or nonsquamous NSCLC as monotherapy in adults whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations; and treatment of locally advanced or metastatic NSCLC in adults whose tumors express PD-L1 (TPS ≥1%) and who have received at least one prior chemotherapy regimen (KEYNOTE-010).
“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,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“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.”