Bristol-Myers Squibb Company (NYSE: BMY) 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 3 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%).
"We are extremely pleased that the European Commission has approved Opdivo plus low-dose Yervoy based on the significant survival benefit demonstrated in the CheckMate -214 trial," said Chris Boerner, Chief Commercial Officer, Bristol-Myers Squibb. "Today's approval helps further our goal of transforming the way cancer is treated and increasing quality, long-term survival for patients."
About CheckMate -214
CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo 3 mg/kg plus Yervoy 1 mg/kg versus sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC). In the intermediate- and poor-risk study population, 425 patients received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses, followed by Opdivo 3 mg/kg every two weeks, and 422 patients received sunitinib 50 mg once daily for four weeks, followed by two weeks off every cycle. The recommended dosing for the Opdivo plus low-dose Yervoy combination is Opdivo 3 mg/kg followed by Yervoy 1 mg/kg each infused intravenously over 30 minutes on the same day every three weeks for four doses. After completing four doses of the combination, Opdivo should be administered intravenously 240 mg every two weeks over 30 minutes or 480 mg every four weeks over 60 minutes until disease progression or unacceptable toxicity.
The co-primary efficacy outcome measures of the trial were overall survival, objective response rate (Complete Response + Partial Response) and progressi...
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