(HealthDay News) — For patients with advanced melanoma, nivolumab may improve overall survival and has an acceptable long-term safety profile, according to a study published online March 3 in the Journal of Clinical Oncology.
Suzanne L. Topalian, MD, from Johns Hopkins University in Baltimore, and colleagues examined whether nivolumab can extend survival and maintain response after discontinuation of treatment for patients with advanced melanoma. One hundred seven patients received intravenous nivolumab in an outpatient setting every 2 weeks for up to 96 weeks.
The researchers found that, for nivolumab-treated patients, the median overall survival was 16.8 months, and 1- and 2-year survival rates were 62% and 43%, respectively.
Nearly two-thirds (62%) of patients had received two to five prior systemic therapies. The estimated median response duration was 2 years among 33 patients with objective tumor regressions.
Therapy was discontinued in 17 patients for reasons other than disease progression, and 71% of these maintained responses while off therapy for at least 16 weeks. Overall response and toxicity rates were comparable to those reported earlier.
Exposure-adjusted toxicity rates were not cumulative in an analysis of all patients treated on this trial, including those with other cancer types.
“Overall survival following nivolumab treatment in patients with advanced treatment-refractory melanoma compares favorably with that in literature studies of similar patient populations,” the researchers wrote.
Several authors disclosed financial ties to pharmaceutical companies, including Bristol-Myers Squibb and Ono Pharmaceutical, which supported the study and manufacture nivolumab.
In an accompanying editorial, several authors wrote, “If future clinical trialsvalidate the findings that have been seen in recent years, perhapsimmunotherapy will not just raise expectations, but the all-important survival tail of Kaplan-Meier curves as well.”
- Topalian SL, Sznol M, McDermott DF, et al. Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab. J Clin Oncol. 2014; doi:10.1200/JCO.2013.53.0105.
- O’Sullivan G, Madan RA, Gulley JL. Nivolumab: Promising Survival Signal Coupled With Limited Toxicity Raises Expectations. J Clin Oncol. 2014; doi:10.1200/JCO.2013.54.5996.