Nivolumab appears to be more active and safer than chemotherapy in patients with advanced melanoma who have received previous treatment. These findings were presented at the 2014 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, September 26–30.
Of the more than one million new diagnoses of skin cancer each year, roughly 68,000 involve melanoma. More than 8,000 people die of melanoma each year in the United States. Melanoma is dangerous because it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body.
Nivolumab belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer. Nivolumab works by blocking PD-1.
Earlier this year, a clinical trial evaluating nivolumab as first-line, or initial, therapy for patients with advanced melanoma was halted early after it was determined that the drug was likely to prolong survival. An interim analysis, performed by an independent data-monitoring committee, found that patients receiving nivolumab had better overall survival compared with those who received the chemotherapy dacarbazine. Patients in the chemotherapy group were allowed to switch to nivolumab.
Researchers are also studying nivolumab in patients with advanced melanoma whose disease has progressed during or after other therapy. The recent study presented at ESMO evaluated nivolumab in patients with progression during or after treatment with anti-CTLA-4 therapy and a BRAF inhibitor.
A total of 370 patients were assigned to receive either nivolumab (268 patients) or chemotherapy (102 patients), which included dacarbazine or carboplatin plus paclitaxel. Treatment continued until disease progressed or side effects became unacceptable.
Beginning at six months, a portion of patients in both treatment groups was assessed for partial or complete response.
- Of the 120 evaluated patients in the nivolumab group, 32% had responded to treatment—compared with just 11% of patients in the chemotherapy group.
- Patients in the nivolumab group tended to respond to treatment more quickly: their median response time with just over 2 months, whereas median response time in the chemotherapy group was three and a half months.
- Nivolumab also appeared to more effectively reduce melanoma lesions: there was a more than 50% reduction in measured lesions in 82% of patients responding to nivolumab versus 60% in patients responding to chemotherapy.
- Median duration of response in the nivolumab hasn’t been reached yet, but with a projected range from more than one month to over 10 months, it will be longer than the median duration of just under four months in the chemotherapy group.
- Side effects, including complications that required patients to stop treatment, were less frequent in the nivolumab group.
With a response rate for nivolumab that was three times higher than chemotherapy, as well as less severe side effects, this drug is emerging as a promising treatment option for previously treated patients with advanced melanoma. This is welcome news for this patient population, which is in need of options for disease that progresses after initial therapy.
Weber J, D’Angelo S, Gutzmer R, et al. LBA3_PR – A Phase 3 Randomized, Open-Label Study of Nivolumab (Anti-PD-1; BMS-936558; ONO-4538) Versus Investigator’s Choice Chemotherapy (ICC) in Patients with Advanced Melanoma after Prior Anti-CTLA-4 Therapy. European Society for Medical Oncology (ESMO) Congress 2014: Abstract LBA3_PR. Presented September 29, 2014.
 Topalian SL, Sznol M, McDermott DF, et al. Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab. Journal of Clinical Oncology [early online publication]. March 3, 2014. doi: 10.1200/JCO.2013.53.0105.
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