Bristol-Myers Squibb’s nivolumab (Opdivo) has shown a robust five-year overall survival (OS) rate of 34 percent in heavily pretreated patients with metastatic melanoma, who had not received prior ipilimumab (Yervoy) therapy. The results, from a long-term single-arm Phase 1 study, were presented at the 2016 AACR annual meeting.
The study, CA209-003, followed 107 patients who were administered nivolumab, a programmed death-1 (PD-1) inhibitor. Participants received nivolumab across five dose levels every two weeks. Doses were escalated from 0.1 mg/kg to 10 mg/kg, and patients continued taking nivolumab for 96 weeks.
“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 in a press release.
The study is significant for demonstrating the potential of cancer immunotherapy, in people with advanced disease, in preventing the disease’s return. It is also the first to assess long-term survival using an anti-PD-1 agent.
Results showed that the survival rate reached 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,” Dr. Hodi said.
Treatment safety and tolerability were the study’s primary endpoints. The most commonly observed adverse events related with the treatment included cough, rash, and common serious events included immune system attacks on organs.
Nivolumab is currently approved by the U.S. Food and Drug Administration (FDA) as a single agent and in combination with ipilimumab for patients with metastatic melanoma. Additionally, the agent is approved for patients with non-squamous and squamous non-small cell lung cancer (NSCLC) and for those with metastatic renal cell carcinoma (RCC).
Massachusetts General Hospital researchers working in a mouse model of melanoma found that a specific type of immune cell — called subcapsular sinus (SCS) macrophages — forms a protective coat around lymph nodes to prevent cancer tissue invasion and to protect against tumor progression. But the coating is temporary, breaking down as tumors develop and under certain chemotherapy and immune therapy drugs.