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Extended Follow-up From KEYNOTE-426: Pembrolizumab Plus Axitinib in Kidney Cancer

By: Joseph Fanelli
Posted: Monday, January 11, 2021

Extended follow-up results from the phase III KEYNOTE-426 study, presented in The Lancet Oncology, demonstrate that pembrolizumab plus axitinib provides superior clinical outcomes over treatment with sunitinib alone for patients with advanced renal cell carcinoma. Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues concluded that pembrolizumab plus axitinib remains the standard of care for this population.

“The results…probably represent a more mature signal regarding the benefits of pembrolizumab plus axitinib treatment over sunitinib monotherapy and support that earlier immunotherapy improves survival,” the authors said.

In this ongoing, open-label trial, the authors enrolled 861 patients with treatment-naive, advanced renal cell carcinoma who had clear cell histology. Patients received treatment with 200 mg of pembrolizumab intravenously every 3 weeks for up to 35 cycles plus 5 mg of axitinib twice daily (432 patients) or 50 mg of sunitinib monotherapy orally once daily for 4 weeks every 6-week cycle (429 patients).

After a median follow-up of 30.6 months, the authors observed a continued clinical benefit for patients treated with pembrolizumab plus axitinib over sunitinib in regard to overall survival (median not reached vs. 35.7 months, respectively) and progression-free survival (median 15.4 months vs. 11.1 months, respectively).

The most frequent treatment-related grade 3 or worse adverse events for both groups of patients were hypertension, alanine aminotransferase increase, and diarrhea. The authors reported no new treatment-related deaths since the first interim analysis.

Disclosure: For full disclosure of the study authors, visit thelancet.com.



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