Nivolumab plus cabozantinib improves outcomes in advanced renal cell carcinoma
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SAN FRANCISCO — Nivolumab plus cabozantinib extended OS and PFS compared with sunitinib as first-line treatment for patients with advanced renal cell carcinoma, according to updated results of the randomized phase 3 CheckMate 9ER trial.
An analysis performed after a median 44 months of follow-up showed the benefit persisted regardless of PD-L1 status, findings presented at ASCO Genitourinary Cancers Symposium showed.
“This is the first time we have this long of maturity in a [trial of an] immunotherapy/[tyrosine kinase inhibitor] combination [in this setting],” Mauricio Burotto, MD, medical oncologist at Bradford Hill Clinical Research Center in Chile, told Healio. “With this data, [physicians] can hopefully choose, with more confidence, this combination instead of others.”
Background and methodology
The CheckMate 9ER trial assessed the efficacy and safety of nivolumab (Opdivo, Bristol Myers Squibb) — a PD-1 immune checkpoint inhibitor — and cabozantinib (Cabometyx, Exelixis), a multitargeted TKI, vs. sunitinib (Sutent, Pfizer), a TKI that targets VEGFR.
The trial included 651 patients with advanced renal cell carcinoma.
Researchers randomly assigned 323 patients to 240 mg IV nivolumab every 2 weeks plus 40 mg oral cabozantinib daily. The other 328 patients received 50 mg oral sunitinib daily in a 4-weeks-on, 2-weeks-off schedule.
Treatment continued until disease progression or unacceptable toxicity.
PFS served as the primary endpoint. OS, objective response rate and safety served as secondary endpoints.
Results
Previously reported results — based on median follow-up of 32.9 months — showed patients assigned nivolumab-cabozantinib achieved longer PFS (median, 16.6 months vs. 8.3 months; HR = 0.56; 95% CI, 0.46-0.68) and OS (median, 37.7 months vs. 34.3 months; HR = 0.7; 95% CI, 0.55-0.9).
At ASCO GU, Burotto reported results based on median follow-up of 44 months.
Results continued to show benefit with the nivolumab-cabozantinib combination with regard to PFS (median, 16.6 months vs. 8.4 months; HR = 0.58; 95% CI, 0.48-0.71) and OS (median, 49.5 months vs. 35.5 months; HR = 0.7; 95% CI, 0.56-0.87).
Results also showed a higher ORR in the nivolumab-cabozantinib group (55.7% vs. 28.4%).
Researchers observed no new safety signals during the additional follow-up.
Nearly all patients experienced any-grade treatment-related adverse events (97% for the combination vs. 93% with sunitinib). A higher percentage of those assigned the combination experienced grade 3 or higher treatment-related adverse events (67% vs. 55%).
Next steps
The updated results suggest the nivolumab-cabozantinib combination is a viable treatment option for patients with advanced renal cell carcinoma, Burotto said.
“The most important thing is to get all data ... [to] see if we can see a tail in the curve and [whether] we can really cure some patients with this combination,” Burotto told Healio. “I believe we can.”
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Burotto M, et al. Abstract 603. Presented at: ASCO Genitourinary Cancers Symposium; Feb. 16-18, 2023: San Francisco.
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