European Commission approves Opdivo + Yervoy ( low dose) for first line treatment of renal cell carcinoma.- BMS

Bristol-Myers Squibb Company announced that the European Commission has approved the combination of Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (�low-dose�) for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This decision represents the first approval of an Immuno-Oncology (I-O) combination therapy for patients with this type of cancer in the European Union.

�Currently, less than 50% of patients with metastatic renal cell carcinoma survive beyond two years, and there is almost no complete remission observed, which underscores the need for new treatments for this disease,� said Bernard Escudier, MD, ex-Chairman of the Genitourinary Oncology Committee, Institut Gustave Roussy. �Today�s approval offers patients in the European Union a first-line treatment option that has demonstrated a complete response rate of almost 10% and a significant improvement in overall survival with fewer Grade 3 and 4 adverse reactions compared to sunitinib.�

The approval is based on results from the Phase III CheckMate -214 clinical trial, which was stopped early following a planned interim analysis that showed that the combination of Opdivo plus low-dose Yervoy demonstrated a significant increase in overall survival (OS), with a 37% decreased risk of death in intermediate- and poor-risk patients 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). the os benefit was observed regardless of pd-l1 expression level. 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 demonstrated 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)" and a complete response rate of 9.4 for the opdivo plus low-dose yervoy cohort versus 1.2 for the sunitinib arm. among patients who responded median duration of response in patients treated with opdivo plus low-dose yervoy was not yet reached 95 ci: 21.8 to ne compared to 18.2 months for sunitinib 95 ci: 14.8 to ne. the combination of opdivo plus low-dose yervoy was also associated with fewer overall grade 3 or 4 adverse events compared to sunitinib 65 versus 76...>