First anti-PD-1 therapy approved in Europe for previously untreated patients with metastatic NSCLC.

Merck (MSD) has received approval from the European Commission for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumuors have high PD-L1 expression (tumour proportion score [TPS] of 50% or more) with no EGFR or ALK positive tumour mutations.

"The approval of Keytruda as a first treatment instead of chemotherapy for patients who express high levels of PD-L1 has the potential to transform the way metastatic NSCLC is treated," said Dr Roy Baynes, senior vice president, head of clinical development, and chief medical officer, Merck Research Laboratories. "We are committed to ensuring that patients in Europe – who are in need of new treatment options – are able to quickly gain access to Keytruda." The approval is based on Phase III data, which demonstrated superior overall survival (OS) and progression-free survival (PFS) with Keytruda compared with chemotherapy, the current standard of care for advanced NSCLC. The approval allows marketing of Keytruda in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every 3 weeks until disease progression or unacceptable toxicity. In August 2016, Keytruda (pembrolizumab) (2 mg/kg every 3 weeks) was approved in Europe for previously-treated patients with locally advanced or metastatic NSCLC whose tumours express PD-L1 (TPS of 1% or more) and who have received at least one prior chemotherapy regimen. "The data demonstrate that Keytruda provided meaningful improvements in survival versus the current standard of care in patients whose tumours express high levels of PD-L1," said Dr Luis Paz-Ares, chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, Spain. "These findings supporting the approval also provide further rationale for biomarker testing to identify those patients more likely to benefit the most from treatment with Keytruda."