The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

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.

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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.

Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2021 meeting by visiting the conference page.


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.