This approval marks the first-ever for 2 immuno-oncology agents in cancer treatment.
In a press release published today, Bristol-Myers Squibb (BMS) announced the approval of its combination regimen of 2 immuno-oncology agents, nivolumab (Opdivo) and ipilimumab (Yervoy), for patients with BRAF V600 wild-type metastatic melanoma.
This approval marks the first-ever approval of 2 immuno-oncology agents in cancer treatment. According to the FDA, the approval was based on objective response rate, prolonged duration of response, and improvement in progression free survival—outcomes from the CheckMate-069 trial in 142 treatment-naïve patients with unresectable or metastatic melanoma. The trial showed a statistically significant increase in confirmed objective response rate in 95 patients with melanoma expressing wild-type BRAF treated with the combination (60%; 95% confidence interval (CI), 48-71; P<.001), compared with ipilimumab and placebo (47 patients) (11%; 95% CI, 3-25). Nearly 17% of patients treated with the combination had a complete response, while 43% had a partial response.
A 60% reduction in the risk of progression was observed with the combination treatment compared with ipilimumab alone (Hazard ratio = 0.40; 95% CI: 0.22-0.71; P<.002). Median survival improved by more than 4 months with the combination, 8.9 months compared with 4.7 months seen with the ipilimumab-treated cohort.
The combination was, however, responsible for more serious adverse events (62% vs 39%), adverse reactions leading to permanent discontinuation (43% vs 11%) or dose delay (47% vs 2%), and grade 3 or 4 adverse reactions (69% vs 43%). The most frequent serious adverse reactions in patients receiving the combination were colitis (17%), diarrhea (9%), pyrexia (6%), and pneumonitis (5%). Additional clinically significant immune-mediated adverse reactions included pneumonitis, hepatitis, endocrinopathies, nephritis/renal dysfunction, and rash.
“Today’s approval of the Opdivo + Yervoy Regimen marks another first for our research in Immuno-Oncology and represents our unwavering commitment to continually redefine cancer care, and offer patients new treatment options with the goal of improved outcomes,” said Giovanni Caforio, CEO of BMS.