EC OKs Merck KEYTRUDA, Chemo for First-Line Non-Small Cell Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of adults with metastatic squamous non-small cell lung cancer (NSCLC). This approval is based on data from the Phase 3 KEYNOTE-407 trial, which demonstrated that KEYTRUDA in combination with chemotherapy 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 (HR=0.64 [95% CI, 0.49-0.85]; p=0.0008).

“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, 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.”

The approval allows marketing of the KEYTRUDA combination in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity. In NSCLC, KEYTRUDA is also approved in Europe for the:

• First-line treatment of metastatic nonsquamous NSCLC in combination with pemetrexed and platinum chemotherapy in adults whose tumors have no EGFR or ALK positive mutations (KEYNOTE-189);
• First-line treatment of metastatic squamous or nonsquamous NSCLC as monotherapy in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) with no EGFR or ALK positive tumor mutations (KEYNOTE-024); 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).

https://www.biospace.com/article/releases/european-commission-approves-merck-s-keytruda-pembrolizumab-in-combination-with-chemotherapy-for-first-line-treatment-of-adults-with-metastatic-squamous-non-small-cell-lung-cancer-nsclc-/