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# Novartis Phase 3 Lung Cancer Trial Doesn’t Hit Endpoints
- URL: https://www.fdaweb.com/novartis-phase-3-lung-cancer-trial-doesnt-hit-endpoints/
- Published: 2021-10-26T12:00:00.000Z
- Updated: 2026-09-14T17:20:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150442

Novartis says the CANOPY-1 Phase 3 study of canakinumab in lung cancer did not meet its primary endpoints of overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic non-small cell lung cancer. The company [says](https://www.novartis.com/news/media-releases/novartis-top-line-results-canopy-1-phase-iii-study-support-further-evaluation-canakinumab-lung-cancer?ref=fdaweb.com) patients in the treatment arm received canakinumab combined with pembrolizumab (Merck’s Keytruda) plus platinum-based doublet chemotherapy, compared to patients receiving placebo in combination with pembrolizumab plus platinum-based doublet chemotherapy.

The company says that while the drug did not meet the primary endpoints, it showed potentially clinically meaningful improvements in both progression-free survival and overall survival in pre-specified subgroups of patients based on biomarkers. “These data support further evaluation of canakinumab in lung cancer,” Novartis says.

Canakinumab is described as a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta and neutralizes its activity by blocking its interaction with its receptors.