Bristol-Myers Squibb (BMS) said that European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the approval of Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
This recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
Bristol-Myers Squibb melanoma and genitourinary cancers development lead said: “There remains a high unmet medical need for patients with advanced renal cell carcinoma.
“We are encouraged by today’s positive opinion from the CHMP and look forward to potentially bringing the first Immuno-Oncology combination therapy to appropriate RCC patients across the EU.”
The CHMP recommendation is based on positive data from the Phase 3 CheckMate -214 clinical trial, which was stopped early following a planned interim analysis that showed the combination of Opdivo 3 mg/kg plus Yervoy 1 mg/kg demonstrated a significant increase in overall survival (OS) with a 37% decreased risk of death in intermediate- and poor-risk patients, regardless of PD-L1 expression level, compared to a current standard of care, sunitinib (Hazard Ratio [HR] 0.63; 99.8% Confidence Interval [CI]: 0.44 to 0.89; p<0.0001).
Median OS in patients treated with Opdivo plus low-dose Yervoy was not yet reached (95% CI: 28.2 to not estimable [NE]), compared to 25.9 months for patients treated with sunitinib.
Opdivo plus low-dose Yervoy also delivered durable responses with a higher objective response rate of 41.6% (95% CI: 36.9 to 46.5; p<0.0001; n=177/425) versus 26.5% for sunitinib (95% CI: 22.4 to 31.0; n=112/422). Median duration of response (durability) for Opdivo plus low-dose Yervoy was not yet reached (95% CI: 21.8 to NE) among responded patients, compared to 18.2 months for sunitinib (95% CI: 14.8 to NE).
The overall safety profile was consistent with prior studies of Opdivo in combination with low-dose Yervoy.
The results of the CheckMate -214 study were first presented at the European Society for Medical Oncology (ESMO) 2017 Congress and were published in the New England Journal of Medicine in March 2018.
Source: Company Press Release