Updated results from the phase 3 KEYNOTE-426 trial found that pembrolizumab plus axitinib continued to demonstrate superior and durable antitumor activity compared with sunitinib as first-line therapy for patients with advanced renal cell carcinoma (aRCC), investigators reported at the ASCO20 Virtual Scientific Program. The analysis also found no new safety issues with the dual-drug regimen.

For the KEYNOTE-426 trial, investigators randomly assigned 861 treatment-naive patients with clear cell aRCC to receive pembolizumab 200 mg IV once every 3 weeks for up to 35 doses plus axitinib 5 mg orally twice daily (432 patients) or sunitinib (429 patients).

At the first preplanned interim analysis (minimum study follow-up of 7 months), results showed that the dual regimen significantly improved overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) compared with sunitinib as first-line therapy for aRCC.

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After a median follow-up period of 27 months, the combination treatment was significantly associated with an improved 24-month overall survival (OS) rate (74% vs 66%) compared with sunitinib, Elizabeth R. Plimack, MD, MS, of Fox Chase Cancer Center in Philadelphia, Pennsylvania, and colleagues reported. Pembrolizumab plus axitinib was significantly associated with a 32% decreased risk of death compared with sunitinib (95% CI, 0.55-0.85; P < .001). Median OS was 35.7 months among sunitinib recipients and was not reached in the combination-treatment arm.

The 24-month PFS rate was 38% in the pembrolizumab-axitinib arm compared with 27% among sunitinib recipients. Median PFS was 15.4 months in the combination-treatment arm compared with 11.1 months in the sunitinib arm. Pembrolizumab plus axitinib was significantly associated with a 29% decreased risk of progression (95% CI, 0.60-0.84; P <.001).

Recipients of the combination regimen had a significantly higher ORR than the monotherapy arm (60% vs 40%; P <.0001). The complete response rate and median duration of response were both higher in the pembrolizumab-axitinib group than the sunitinib group (9% vs 3% and 23.5 vs 15.9 months, respectively).

Disclosure: Research was funded by Merck Sharp & Dohme Corp. For a full list of disclosures, please refer to the original abstract.


Plimack ER, Rini BI, Stus V, et al. Pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced renal cell carcinoma (RCC): Updated analysis of KEYNOTE-426. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 5001.

This article originally appeared on Cancer Therapy Advisor