Phase 3 trial of canakinumab for advanced NSCLC misses primary endpoint
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A randomized phase 3 trial designed to evaluate canakinumab plus chemotherapy for advanced non-small cell lung cancer failed to meet its primary endpoint of OS, according to the agent’s manufacturer.
Canakinumab (ACZ885, Novartis) is a human monoclonal antibody that targets interleukin-1 beta.
The CANOPY-2 trial included 237 adults with locally advanced or metastatic NSCLC whose disease progressed on or after platinum-based chemotherapy and immunotherapy with a PD-1/PD-L1 inhibitor.
Results showed the addition of canakinumab to docetaxel as second- or third-line treatment failed to extend OS compared with docetaxel alone.
Complete results will be submitted for presentation at a medical meeting.
“While results from the CANOPY-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other lines of therapy, these data give us valuable insights into interleukin-1 beta inhibition,” John Tsai, MD, head of global drug development and chief medical officer for Novartis, said in a company-issued press release.
Two phase 3 trials designed to evaluate canakinumab in earlier settings for patients with NSCLC will continue.
Results of CANOPY-1, which is investigating canakinumab in combination with first-line pembrolizumab (Keytruda, Merck) and platinum-based doublet chemotherapy, are expected by the end of this year. Enrollment for CANOPY-A, which is investigating canakinumab as adjuvant therapy after surgical resection and cisplatin-based chemotherapy, has enrolled more than 950 patients. Target enrollment is 1,500 patients.
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