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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 (nivolumab) 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.
“The efficacy was sustained across multiple subgroups, further underscoring the potential of this regimen to benefit a broad population with variable disease burden. We are proud to have established such a compelling standard of care for this community and remain committed to developing much-needed treatment options for all patients living with advanced cancers.”
Research carried out by GlobalData found that in 2024 Cabometyx brought in $1.7bn for Exelixis, with that number expected to grow to $2.3bn by 2029. At the same time, Opdivo brought in more than $9.3bn in 2024 alone.
GlobalData is the parent company of Clinical Trials Arena.
The announcement follows after Exelixis partnered with pharmaceutical giant MSD to examine its tyrosine kinase inhibitor Zanzalintinib alongside Keytruda. Elsewhere in the field of RCC treatment, US-based biotechnology company Adicet Bio has dosed the first subject in a multicentre Phase I trial of ADI-270, a gamma delta CAR T-cell therapy.