More than one-third of patients with previously treated advanced melanoma survived at least five years after taking Bristol-Myers Squibb’s nivolumab (Opdivo), according to a recent study.
The Phase 1 study, presented Sunday at the American Association for Cancer Research (AACR) annual meeting, followed 107 patients who took the programmed death-1 (PD-1) inhibitor. Study participants who took single-agent nivolumab had a 5-year overall survival (OS) of 34 percent.
“These data represent the longest survival follow-up of patients who received anti-PD-1 therapy in a clinical study, and suggest durable, long-term survival with nivolumab monotherapy,” F. Stephen Hodi, MD, of Dana-Farber Cancer Institute in Boston, said at an AACR press briefing.
The study is particularly significant because it demonstrates the strength of cancer immunotherapy at advanced stages, in stopping the disease from returning. It is also the first study to look at long-term survival for an anti-PD-1 agent. (The Phase 1 study of nivolumab was conducted in 2008).
In the study, labeled CA209-003, patients received nivolumab across five dose levels every two weeks. Doses were escalated from 0.1 mg/kg to 10 mg/kg and were continued for as long as 96 weeks.
The survival rate seemed to reach a plateau at about 48 months. “In all patients, there is a plateauing, and it’s lasting many months to years, and about a third of patients have this long-term survival, said Hodi, in an OncLive article.
Nivolumab has demonstrated efficacy in melanoma and other advanced cancers. The drug was approved for melanoma by the FDA in 2014. In the U.S., nivolumab’s approved indications include use as a single agent or in combination with ipilimumab (Yervoy), also from BMS, for first-line treatment of advanced melanoma.
The trial’s primary objective was safety and tolerability. Common side effects included rash, cough, and more seriously, immune system attacks on organs, like the lung and colon.
Melanoma is the most aggressive form of skin cancer, with an increase in global incidence rates over the last 30 years. Patients with advances stages of the disease have lower survival rates, with a five-year survival of 15 to 20 percent for Stage IV.
In 2016, approximately 76,000 new melanoma cases will be diagnosed, and about 10,000 people are expected to die of melanoma, according to the American Cancer Society.
Source: Hodi FS, et al ‘Durable, long-term survival in previously treated patients with advanced melanoma who received nivolumab monotherapy in a phase 1 trial” AACR 2016; Abstract CT001.
Filed Under: Drug Discovery