Pembrolizumab plus axitinib shows durable benefit in clear cell renal cell carcinoma
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CHICAGO — Pembrolizumab plus axitinib continued to confer a survival benefit vs. sunitinib at 5-year follow-up as first-line therapy for patients with advanced clear cell renal cell carcinoma, according to study results.
The long-term data, presented at ASCO Annual Meeting, showed improved outcomes with the combination even though more patients in the sunitinib group had subsequent treatment and more therapy lines.
“KEYNOTE-426 represents the longest follow-up to date of a checkpoint inhibitor plus a VEGFR [tyrosine kinase inhibitor] for first-line clear cell [renal cell carcinoma],” Brian I. Rini, MD, professor of medicine in the hematology oncology division at Vanderbilt University Medical Center, said during a presentation. “Pembrolizumab plus axitinib continues to demonstrate improved OS, PFS and overall response rate compared [with] sunitinib monotherapy in patients with previously untreated clear cell kidney cancer.”
Background and methodology
The randomized, phase 3 KEYNOTE-426 study assessed the efficacy of first-line treatment of pembrolizumab (Keytruda, Merck) and axitinib (Inlyta, Pfizer) compared with sunitinib (Sutent, Pfizer) for advanced clear cell renal cell carcinoma.
Eligible patients included adults with confirmed locally advanced or metastatic clear cell renal cell carcinoma with or without sarcomatoid features, no previous systemic therapy for advanced disease, a Karnofsky performance score of 70% or greater and at least one lesion measurable per RECIST v1.1.
Researchers randomly assigned patients 1:1 to receive either 200 mg pembrolizumab once every 3 weeks for up to 35 cycles plus 5 mg axitinib orally twice daily (n = 432) or 50 mg sunitinib orally twice daily for the first 4 weeks of 6-week cycles (n = 429).
OS and PFS served as primary endpoints. Secondary endpoints of ORR and duration of response.
Results
After median follow-up of 67.2 months (range, 60-75), results showed median PFS of 15.7 months (95% CI, 13.6-20.2) among patients in the combination group and 11.1 months (95% CI, 8.9-12.5) among patients in the sunitinib group (HR = 0.69; 95% CI, 0.59-0.81).
Researchers also noted longer median OS with the combination (47.2 months vs. 40.8 months; HR = 0.84; 95% CI, 0.71-0.99) and a higher ORR (60.6% vs. 39.6%).
Among patients who discontinued treatment, 62.2% of patients in the combination arm received subsequent anticancer treatment vs. 73.9% of patients receiving monotherapy.
Researchers noted an HR of 0.67 (95% CI, 0.52-0.84) for OS when adjusted for subsequent therapy. They observed no new safety signals with the pembrolizumab regimen.
A total of 27.8% of patients assigned the pembrolizumab regimen completed all 35 cycles of the PD-1 inhibitor. Those patients had an ORR of 85%, with a 5-year OS rate of 70.7% and 5-year PFS rate of 32.8%.
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Rini BI, et al. Abstract LBA4501. Presented at: ASCO Annual Meeting 2023; June 2-6, 2023: Chicago.
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