Phase 3 trial of canakinumab for lung cancer misses primary endpoints
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The addition of canakinumab to pembrolizumab and chemotherapy failed to extend PFS or OS among patients with advanced non-small cell lung cancer, according to topline results of a randomized phase 3 trial.
However, results showed potentially clinically meaningful improvements in both outcomes among prespecified subgroups.
Canakinumab (ACZ885, Novartis) is an interleukin-1-beta inhibitor of the pro-tumor inflammation pathway in NSCLC.
The CANOPY-1 trial assessed the addition of canakinumab to pembrolizumab (Keytruda, Merck) and platinum-based doublet chemotherapy for patients with previously untreated locally advanced or metastatic NSCLC.
Results showed no benefit in PFS or OS — the study’s primary endpoints — with canakinumab.
Researchers reported potentially clinically meaningful improvements in both survival endpoints among prespecified subgroups of patients based on the baseline inflammatory marker hs-CRP, as well as other biomarker-defined subgroups, according to a Novartis-issued press release. Additional analyses are ongoing.
Results showed no unexpected safety signals with canakinumab when combined with pembrolizumab and platinum-based chemotherapy.
Complete results from CANOPY-1 will be submitted for presentation at a medical meeting.
“CANOPY-1 provides critical insights into the treatment of this devastating disease, and we will continue to analyze the data and conclusions, as well as their potential clinical implications,” John Tsai, MD, head of global drug development and chief medical officer for Novartis, said in the release. “[Although] this trial did not confirm the benefit for all patients we hoped for, we are energized by the overall CANOPY-1 findings as they support our commitment to continue studying canakinumab in lung cancer.”
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