European regulators have taken a key step toward authorizing Keytruda (pembrolizumab) as a therapy for certain kinds of metastatic non-small cell lung cancer patients.
The European Medicines Agency’s Committee for Medical Products for Human Use has recommended the treatment for patients with high PD-L1 levels and no ALK or EGFR mutations.
“Lung cancer is one of the leading causes of death in the EU, so today’s news is an important step forward for many patients in Europe,” Dr. Roger Dansey, a senior vice president at Merck Research Laboratories, said in a news release. “If approved, patients with metastatic non-small cell lung cancer with high PD-L1 expression could receive Keytruda instead of chemotherapy as their initial treatment.”
The research on the KEYNOTE-024 Phase 3 trial, “Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer,” was published in The New England Journal of Medicine.
The next step in treatment approval is for the European Commission to decide whether Keytruda should be marketed in the European Union for patients with high PD-L1 levels and no ALK or EGFR mutations.. That decision is expected in the first quarter of 2017.
Keytruda-024 (NCT02142738) was a randomized, multi-arm, open-label study designed to assess the safety and effectiveness of Keytruda compared with platinum-based chemotherapies in patients with PD-L1 who had yet to receive a treatment. The chemotherapies were Taxol (paclitaxel), Paraplatin (carboplatin), Alimta (pemetrexed), Platinol (cisplatin), and Gemzar (gemcitabine).
The trial showed that Keytruda improved patients’ rate of survival without the disease progressing, and their overall survival rate, better than chemotherapy.
The free-of-progression rate was 10.3 months for those getting Keytruda, versus 6 months for those getting chemotherapy. The six-month overall survival rate was 80.2% for Keytruda patients, versus 72.4% for chemotherapy patients.
The therapy response rate was also higher with Keytruda (44.8% vs. 27.8%), as was the duration of the response (no time vs. 6.3 months). Keytrude also led to fewer side effects (73.4% vs. 90.0%).
Keytruda is already approved in Europe for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have high-levels of PD-L1 and who have received at least one prior therapy. It is also approved for patients with EGFR or ALK mutations whose cancer progressed after receiving an EGFR or ALK inhibitor.