Date: 2018-10-12
Type of
information: Results
phase: 3
Announcement: results
Company: BMS (USA - NY)
Product: Opdivo® (nivolumab)
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor.
- Nivolumab is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. PD-1, a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body. Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them. Opdivo® is the world’s first approved drug targeting PD-1.
- This monoclonal antibody has been generated under a research collaboration entered into in May 2005 between Ono and Medarex. When Medarex was acquired by BMS in 2009, it also granted BMS its rights to develop and commercialize the anti-human PD-1 monoclonal antibody in North America. Through the collaboration agreement entered into in September 2011 between Ono and BMS, Ono granted BMS exclusive rights to develop and commercialize Opdivo® in the rest of the world, except in Japan, Korea and Taiwan where Ono has retained all rights to develop and commercialize the compound.
Disease: relapsed small cell lung cancer
Therapeutic
area: Cancer - Oncology
Country: Australia, Austria, Belgium, Brazil, Chile, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Norway, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, UK, USA
Trial
details:
- CheckMate -331 study is an open-label, randomized Phase 3 study evaluating nivolumab monotherapy versus chemotherapy in patients with relapsed small cell lung cancer (SCLC) following platinum-based chemotherapy. Patients were randomized to two treatment arms: an experimental arm assessing Opdivo; and an active comparator arm evaluating topotecan (or amrubicin, upon investigator’s choice, where locally approved for second-line SCLC treatment). The primary objective was overall survival. Secondary endpoints included progression-free survival and objective response rate. (NCT02481830)
Latest
news:
- • On October 12, 2018, BMS announced that Phase 3 CheckMate -331 study does not meet primary endpoint of overall survivald in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The trial was evaluating nivolumab versus the current standard of care, topotecan or amrubicin (where approved). The safety profile of nivolumab in this trial was consistent with that observed in previously reported monotherapy studies involving patients with SCLC.
Is
general: Yes
