FROM THE SMR INTERNATIONAL CONGRESS
Nivolumab achieves significant improvements in overall survival and progression-free survival compared with conventional chemotherapy in untreated patients with advanced melanoma, regardless of PD-L1 status, according to data presented at the International Congress for the Society for Melanoma Research.
Data from a randomized, double-blind, placebo-controlled phase III trial showed patients treated with nivolumab – a PD-1 immune checkpoint inhibitor – showed there was a 58% lower incidence of death at 1 year among patients treated with nivolumab compared with those treated with dacarbazine (72.9% vs. 42.1% HR 0.42, 95% CI 0.25-0.73, P < .001).
Median progression-free survival was 5.1 months in the nivolumab arm compared with 2.2 months in the dacarbazine group (HR for death or disease progression: 0.43, 95% CI 0.34-0.56, P < .001). The results were published simultaneously online Nov. 16 in the New England Journal of Medicine.
Researchers randomly assigned 418 previously untreated patients with BRAF mutation-negative advanced melanoma to nivolumab plus placebo, and dacarbazine plus placebo, finding an objective response rate of 40% in patients receiving nivolumab compared with 13.9% in the dacarbazine group.
While PD-L1-positive patients treated with nivolumab showed a greater median response rate compared with PD-L1-negative or indeterminate patients (52.7% vs. 33.1%), both still achieved greater response than either subgroup treated with dacarbazine (N. Engl. J. Med. 2014 Nov. 16 [doi:10.1056/NEJMoa1412082]).
The overall incidence of treatment-related adverse events was similar in the two study arms, although there was a higher incidence of treatment-related grade 3 and 4 adverse events, such as gastrointestinal and hematologic events, in the dacarbazine group.
“It has generally been accepted that immunotherapy is associated with long-term responses in a subset of patients, whereas targeted therapies, such as BRAF inhibitors, are associated with high response rates and a rapid effect, but the responses are often short-lived,” wrote Dr. Caroline Robert of Institut Gustave Roussy, Paris, and her colleagues.
“The present study shows nivolumab is associated with a high response rate, a rapid median time to response (2.1 months, which is similar to the time to response for dacarbazine), and a durable response (the median duration of response was not reached but the duration of follow-up was short),” the investigators said.
The study was supported by Bristol Myers-Squibb. Some authors declared grants, travel expenses, and personal fees from pharmaceutical companies including Bristol Myers-Squibb, and several were employees of the company.
tor@frontlinemedcom.com
