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FDA approves Opdivo for advanced, treatment-naive BRAF wild-type melanoma
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The FDA approved nivolumab as monotherapy for treatment-naive, BRAF wild-type unresectable or metastatic melanoma.
Nivolumab (Opdivo, Bristol-Myers Squibb), administered via IV injection, is the first PD-1 immune checkpoint inhibitor to be approved for single-agent, first-line treatment of advanced BRAF wild-type melanoma.
Jeffrey S. Weber
“Advanced melanoma continues to be one of the deadliest and most challenging cancers to treat, and ongoing research in immuno-oncology from clinical trials … shows the potential to provide improved overall survival for newly diagnosed patients with BRAF wild-type metastatic melanoma,” Jeffrey S. Weber, MD, PhD, deputy director of Laura and Isaac Perlmutter Cancer Center at NYU Langone Medical Center, said in a press release. “This important news means that we now have another new option to offer patients with BRAF wild-type metastatic melanoma.”
The FDA based the approval on results of the phase 3 CheckMate 066 trial, which compared nivolumab with dacarbazine chemotherapy in 418 treatment-naive patients with BRAF wild-type unresectable or metastatic melanoma.
Researchers randomly assigned 210 patients to nivolumab 3 mg/kg every 2 weeks. The other 208 patients received dacarbazine 1,000 mg/m2 every 3 weeks.
OS served as the primary endpoint. Secondary endpoints included PFS and objective response rate.
In an interim analysis, researchers reported significantly longer median OS (not reached vs. 10.8 months; HR = 0.42; 95% CI, 0.3-0.6) and median PFS (5.1 months vs. 2.2 months; HR = 0.43; 95% CI, 0.34-0.56) in the nivolumab arm.
Nivolumab-treated patients also demonstrated higher rates of overall response (34% vs. 9%), complete response (4% vs. 1%) and partial response (30% vs. 8%).
At the time of analysis, 88% of patients in the nivolumab arm had ongoing responses, and 43 patients had responses of at least 6 months.
Based on a recommendation from the independent data monitoring committee, researchers stopped the trial early and allowed patients in the dacarbazine arm to receive nivolumab.
Patients assigned nivolumab experienced higher rates of fatigue (49% vs. 39%), musculoskeletal pain (32% vs. 25%), rash (28% vs. 12%) and pruritus (23% vs. 12%).
About one-third (36%) of patients assigned nivolumab experienced serious adverse events. Also, 41% experienced grade 3 or grade 4 adverse events, the most common of which were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%).
Seven percent of patients assigned nivolumab discontinued treatment due to adverse events, and 26% required dose interruption.
“Our focused approach to immuno-oncology research is to deliver treatment options that have the potential to improve long-term survival outcomes for patients,” Michael Giordano, MD, senior vice president and head of oncology development at Bristol-Myers Squibb, said in a press release. “Opdivo has become a critical part of the treatment landscape for advanced melanoma patients and their physicians, both as a monotherapy and in combination, and we are committed to exploring opportunities for this treatment across stages of disease and lines of therapy.”