European Commission Approves Merck?s KEYTRUDA (pembrolizumab) in Combination with Inlyta (axitinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma (RCC)
European Approval Based on KEYNOTE-426 Trial Results Demonstrating Significant Improvement in Overall Survival with KEYTRUDA in Combination with Axitinib Compared to Sunitinib
KEYTRUDA is First Anti-PD-1 Therapy Approved as Part of a Combination Regimen in Europe for RCC Across All IMDC Risk Groups
September 04, 2019 06:45 AM Eastern Daylight Time
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck?s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This approval includes patients in all IMDC risk groups. It is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated that KEYTRUDA in combination with axitinib reduced the risk of death by 47% compared with sunitinib (HR=0.53 [95% CI, 0.38, 0.74]; p=0.00005) in patients with advanced RCC. The KEYTRUDA with axitinib combination also demonstrated an improvement in progression-free survival (PFS) and objective response rate (ORR) compared with sunitinib.
?Advanced renal cell carcinoma is one of the most lethal types of cancer, with the majority of patients dying within five years of their initial diagnosis,? said Prof. Thomas Powles, lead investigator for KEYNOTE-426 and director of Barts Cancer Centre. ?It?s encouraging that we can now offer patients in Europe the KEYTRUDA with axitinib combination as a first-line treatment option.?
The approval allows marketing of the KEYTRUDA combination in all 28 EU member states plus Iceland, Lichtenstein and Norway.
?The European approval of the KEYTRUDA with axitinib combination for the treatment of advanced RCC marks an important milestone in our efforts for patients with this aggressive disease,? said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. ?Offering an additional treatment option in the first-line setting is particularly important in patients with advanced RCC and underscores our commitment to develop KEYTRUDA in areas of unmet need.?
Data Supporting the European Approval
The approval was based on data from KEYNOTE-426, a Phase 3, randomized, multi-center, open-label, active-controlled trial evaluating KEYTRUDA in combination with axitinib in patients with advanced RCC with clear cell component, regardless of PD-L1 tumor expression status and International Metastatic RCC Database Consortium (IMDC) risk categories. The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression. Randomization was stratified by risk categories (favorable versus intermediate versus poor) and geographic region (North America versus Western Europe versus ?Rest of the World?). The dual primary endpoints were overall survival (OS) and PFS (as assessed by BICR using RECIST 1.1); secondary endpoints included ORR and duration of response (DOR), as assessed by BICR using RECIST 1.1. The study enrolled 861 patients who were randomized (1:1) to one of the following treatment arms:
- KEYTRUDA 200 mg intravenously every three weeks in combination with axitinib 5 mg orally, twice daily. Patients who tolerated axitinib 5 mg twice daily for two consecutive treatment cycles (i.e. 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to = 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily. Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria. Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity.
- Sunitinib 50 mg orally, once daily for four weeks and then off treatment for two weeks.
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
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