Bristol-Myers Squibb has revealed results from its phase III trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).
CheckMate-214 evaluated BMS’ combination therapy versus Pfizer’s Sutent (sunitinib), the current standard of care, in RCC patients. It found an overall survival benefit across programmed death ligand 1 (PD-L1) expression levels, which is how a patient responds to anti-PD-1/L1 antibodies.
Arvin Yang, development lead, melanoma and genitourinary cancers, BMS, said: “As a leader in immuno-oncology, we are committed to improving overall survival and are encouraged by these results in patients with advanced renal cell carcinoma, whose treatment options remain limited.”
Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year, with only a 12.1% five-year survival rate for those diagnosed with metastatic, or advanced kidney cancer.
Yang continued: “We continue to evaluate the potential of Opdivo plus Yervoy in this population and look forward to discussing these results with regulatory authorities.”
Patients also reported a statistically significant better kidney cancer symptom control with the combination compared to sunitinib when assessed using a valid tumour-specific patient-reported kidney cancer scale in the FKSI-19.
Through the first six months of data, when completion rates exceeded 80%, a 3-6 point difference was observed, which is considered clinically meaningful, according to BMS.
Meanwhile, BMS has been investigating this particular combination for other indications, including lung cancer, and the drug maker is hoping to see an approval in the second half of 2018.