Phase 3 trial of canakinumab for non-small cell lung cancer misses endpoint
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A randomized phase 3 trial designed to evaluate canakinumab as adjuvant treatment for completely resected non-small cell lung cancer failed to meet its primary endpoint, according to the agent’s manufacturer.
Canakinumab (ACZ885, Novartis) is a human monoclonal antibody that binds to and inhibits interleukin-1 beta.
The multicenter, double-blind CANOPY-A study included 1,382 patients with stage II, stage IIIA or stage IIIB NSCLC who had cancer-free margins after surgery. If warranted, study participants completed standard adjuvant cisplatin-based chemotherapy and radiation therapy.
Researchers randomly assigned half of study participants to adjuvant treatment with 200 mg canakinumab administered subcutaneously every 3 weeks. The other half received matching placebo. Treatment continued for 1 year.
Investigators reported no improvement in DFS — the study’s primary endpoint — among canakinumab-treated patients.
Researchers observed no new safety signals with canakinumab.
Complete results of CANOPY-A will be submitted for presentation at a medical meeting.
“We made an investment in the CANOPY program based on signals of reduced lung cancer incidence and mortality observed in the CANTOS study. These positive signals supported the study of canakinumab as adjuvant treatment for early lung cancer,” Jeff Legos, executive vice president and global head of oncology and hematology development with Novartis, said in a company-issued press release. “[Although] we are disappointed CANOPY-A did not show the benefit we hoped for, every trial generates scientific evidence that supports future research and development, and we look forward to continuing to pursue new therapeutic options for people living with lung cancer.”
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