Bristol Myers Squibb (BMS), Exelixis and Ipsen have reported positive three-year follow-up results from a phase 3 study of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in advanced renal cell carcinoma (RCC), the most common type of kidney cancer in adults.
More than 431,000 new cases of RCC are diagnosed globally each year, and 179,000 deaths occur as a result of the disease.
RCC is about twice as common in men as it is in women, with the highest rates of the disease in North America and Europe. At diagnosis, up to 30% of patients present with advanced or metastatic RCC.
“Despite the progress made through science and medicine, there remains a need for treatment options that can durably extend survival for patients with metastatic RCC, especially for those classified as higher risk,” said Mauricio Burotto, medical director at Bradford Hill Clinical Research Center.
Results from the analysis of the CheckMate -9ER trial, which represent the longest reported follow-up in any phase 3 trial with an immunotherapy-tyrosine kinase inhibitor regimen in this population, showed sustained survival and response rate benefits with the combination treatment versus Pfizer’s sunitinib.
The combination continued to show a 30% reduction in the risk of death, and improvement in median overall survival versus sunitinib. Additionally, median overall survival improved by 11.8 months since the previous data cut at 32.9 months median follow-up.
Profession-free survival (PFS) benefits were also sustained, with the combination treatment continuing to double median PFS versus sunitinib. Objective response rate, duration of response and complete response rates versus sunitinib were also maintained.
Additionally, a biomarker analysis showed that improvements in median PFS and overall survival were sustained with the combination regardless of PD-L1 status.
The updated results will be shared at the American Society of Clinical Oncology 2023 Genitourinary Cancers Symposium, the companies said.
Vicki Goodman, executive vice president, product development and medical affairs, and chief medical officer at Exelixis, said: “With 44 months median follow-up, the compelling survival benefit further reinforces the value of the Cabometyx and Opdivo combination regimen as a first-line option for patients with advanced kidney cancer.”
Exelixis gave Ipsen exclusive rights for the commercialisation and further clinical development of Cabometyx outside the US and Japan in 2016, and gave Takeda the rights for all future indications in Japan in 2017.