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Merck Receives Positive CHMP Opinion for KEYTRUDA® in Combination Therapy for First-Line Treatment of Non-Epithelioid Mesothelioma

NextEdge Admin

18 Nov 2024

2 min 12 sec

Merck , known as MSD outside the U.S. and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of KEYTRUDA® (pembrolizumab) in combination with pemetrexed and platinum chemotherapy. This therapy is intended as a first-line treatment for adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).

“This milestone brings us closer to offering a new first-line treatment with proven survival benefits for certain EU patients with this challenging cancer,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories.

The recommendation is based on the Phase 2/3 IND.227/KEYNOTE-483 trial, where KEYTRUDA plus chemotherapy showed significant improvements in overall survival (OS) compared to chemotherapy alone. KEYTRUDA reduced the risk of death by 21% (HR=0.79; 95% CI, 0.64-0.98; p=0.0162) and achieved a median OS of 17.3 months versus 16.1 months for chemotherapy alone. Progression-free survival (PFS) also improved (HR=0.80; p=0.0194), with both groups showing a median PFS of 7.1 months. The overall response rate (ORR) was notably higher with KEYTRUDA plus chemotherapy (52% vs. 29%; p<0.00001).

Following its U.S. approval in September 2024, the CHMP recommendation advances the treatment toward European Commission approval, with a final decision expected in Q4 2024. Adverse reactions observed in patients with MPM were consistent with previous findings for this treatment combination.