Novartis Reports Phase 3 CANOPY-1 Study Does Not Meet Endpoints, However Sub-Group Data Supports Further Evaluation of Canakinumab in Lung Cancer

Novartis announced results from the CANOPY-1 Phase III study which evaluated canakinumab (ACZ885) as a first-line treatment for locally advanced or metastatic non-small cell lung cancer. The trial did not demonstrate the statistically significant primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients treated with canakinumab combined with pembrolizumab plus platinum-based doublet chemotherapy, compared to patients receiving placebo in combination with pembrolizumab plus platinum-based doublet chemotherapy. The trial data, however, showed potentially clinically meaningful improvements in both PFS and OS in pre-specified subgroups of patients based on the baseline inflammatory biomarker, hs-CRP, as well as other biomarker-defined subgroups. These data support further evaluation of canakunimab in lung cancer.

Novartis and investigators are collaborating on further data analysis and will present the full dataset at an upcoming medical meeting. The company is continuing with the evaluation of canakinumab in lung cancer.

Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung canc...

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