Five-year results see Exelixis’ RCC therapy extending overall survival

Studied in combination with Opdivo, Cabometyx saw RCC patients surviving 11 months longer than Sunitinib patients reports clinicaltrials.com.

Five-year results from a trial examining Exelixis’ Cabometyx as a therapy for previously untreated advanced renal cell carcinoma (RCC) sustaining progression-free (PFS) and overall survival (OS) over the standard of care (SoC).

The US-based company presented data at the American Society of Clinical Oncology 2025 Genitourinary Cancers Symposium (ASCO GU) 2025 about its therapy Cabometyx, a cabozantinib-based treatment, examined in combination with Bristol Myers Squibb’s Opdivo in the Phase III CheckMate-9ER pivotal trial (NCT02477826).

Examined against the targeted cancer drug sunitinib, results saw the arm treated with combination therapy achieving a median OS of 46.5 months against the monotherapy’s 35.5 months at the median follow-up time of 67.6 months. At the same time, the Cabometyx arm saw an overall response rate (ORR) of 55.7% versus 27.4% with Opdivo.

The open-label, randomised trial enrolled 651 patients across a range of RCC tumour types, including liver, bone and lung. Typically, RCC begins as a form of kidney cancer but has the potential to spread to other parts of the body.

No new safety signals were reported but grade 3/4 adverse events (AEs) occurred in 68% of patients treated with Cabometyx and Opdivo against 55% of patients treated with sunitinib. One treatment-related death per investigator occurred in the Cabometyx group, in the sunitinib group there were three deaths per investigator. Additionally, 28% of patients dosed with the combination therapy saw adverse events forcing investigators to discontinue the therapy.

Amy Peterson, chief medical officer at Exelixis, said: “With now more than five years of follow-up, these results continue to support cabometyx in combination with Opdivo as a treatment regimen that can have enduring survival benefits for patients with previously untreated advanced kidney cancer.

To read the full story visit clinicaltrials.com HERE