US regulators have approved a combination of Bristol-Myers Squibb’s immunotherapy drugs Opdivo and Yervoy as a first-line treatment for patients with advanced renal cell carcinoma.
Approval was based on data from the Phase III CheckMate -214 clinical trial, in which the Opdivo (nivolumab) + Yervoy (ipilimumab) combination showed “a significant and unprecedented increase in overall survival (OS) in this patient population compared to a current standard of care, sunitinib,” according to BMS.
Opdivo + Yervoy reduced the risk of death by 37 percent versus sunitinib, while the objective response rates were 41.6 percent and 26.5 percent, respectively.
An OS benefit was observed regardless of PD-L1 expression level, but there was no significant difference seen in progression free survival between the two treatment arms.
Currently, only 36 percent of patients with advanced RCC survive beyond one year, and only 8 percent will live past five years, highlighting the need for new treatment options.
“Data from the CheckMate -214 trial demonstrated superior overall survival with Opdivo + Yervoy, showing the potential for the combination to become a new standard of care for patients with intermediate- and poor-risk advanced RCC,” said Robert Motzer, medical oncologist, Jack and Dorothy Byrne chair in clinical oncology, Memorial Sloan Kettering Cancer Center.
“What's more, the combination resulted in fewer overall Grade 3 and 4 adverse reactions compared to sunitinib. Because of these encouraging results, we now have a new treatment option for newly diagnosed advanced RCC patients across PD-L1 expression levels.”
Lung cancer success
Meanwhile, BMS also unveiled new data showing that the Opdivo/Yervoy combo slashed the risk of progression or death by 42 percent versus chemotherapy in first-line advanced NSCLC cancer patients whose tumours have high tumour mutation burden (TMB).
Also, based on an early descriptive analysis, encouraging overall survival was observed with the combination versus chemotherapy in patients with high TMB.
“CheckMate -227 is the first Phase III study to demonstrate the important clinical benefit of combining two immunotherapy agents to treat first-line NSCLC patients with high TMB,” said Matthew Hellmann, study investigator and medical oncologist at Memorial Sloan Kettering Cancer Center.
“Results demonstrated that first-line nivolumab plus ipilimumab can provide frequent, deep and durable responses compared with chemotherapy in patients with NSCLC who have TMB ≥10 mut/Mb. The trial also supports the rationale for molecular testing to determine potential biomarkers in patients with lung cancer.”