FDA approves first-line Opdivo-Cabometyx regimen for advanced renal cell carcinoma
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The FDA approved nivolumab in combination with cabozantinib as first-line treatment of patients with advanced renal cell carcinoma, according to a manufacturer-issued press release.
The approval was based, in part, on data presented at ESMO Virtual Congress 2020 from the phase 3 CheckMate –9ER trial, which included 651 patients with advanced or metastatic renal cell carcinoma.
Of them, 323 patients received 240 mg nivolumab (Opdivo, Bristol Myers Squibb), an anti-PD-1 antibody, every 2 weeks in combination with 40 mg daily cabozantinib (Cabometyx, Exelixis), a multitargeted tyrosine kinase inhibitor. The other 328 patients received standard 50 mg daily sunitinib (Sutent, Pfizer) in a 4-weeks-on, 2-weeks-off schedule.
PFS served as the study’s primary endpoint. Secondary endpoints included OS and objective response rate.
Median follow-up was 18.1 months.
As Healio previously reported, the nivolumab-cabozantinib combination conferred median PFS double that of sunitinib (16.6 months vs. 8.3 months; HR = 0.51; 95% CI, 0.41-0.64). The combination also demonstrated an OS benefit (HR = 0.6; 98.9% CI, 0.4-0.89) and an improvement in ORR (55.7% vs. 27.1% P < .0001).
A similar proportion of patients in the combination group and the sunitinib group experienced grade 3 or worse adverse events (75% vs. 71%). In total, 19.7% of patients assigned the combination discontinued treatment (nivolumab, 6.6%; cabozantinib, 7.5%; both, 5.6%).
Serious adverse events associated with the combination occurred among 48% of patients, the most common of which were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection and hyponatremia.
“This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib — progression-free survival, overall survival and objective response rate — while showing a low rate of treatment discontinuations due to side effects. The therapeutic benefit demonstrated in CheckMate -9ER and quality-of-life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” Toni Choueiri, MD, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg professor of medicine at Harvard Medical School, said in the press release. “With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.”
The FDA previously granted this application priority review and reviewed it under the Real-Time Oncology Review pilot program.
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