Trial Evaluating Canakinumab in Lung Cancer Does Not Reach Primary Endpoints, Supports Further Evaluation

In a phase 3 trial of canakinumab, the drug did not meet its primary endpoints of significant survival improvements for patients with non-small cell lung cancer (NSCLC); however, data support further evaluation of the drug in this indication, according to the investigators.

In the CANOPY-1 phase 3 trial, canakinumab (ACZ885), in combination with pembrolizumab plus platinum-based doublet chemotherapy, did not meet the primary endpoints of statistically significant improvements to overall survival (OS) and progression-free survival (PFS) in patients with NSCLC compared to patients receiving placebo. However, the investigators said that the trial data 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.

Novartis describes canakinumab as a potential first-in-class interleukin-1beta (IL-1beta) inhibitor of the pro-tumor inflammation (PTI) pathway in NSCLC. PTI enables tumor development by driving cancer-causing processes and suppressing anti-tumor immune responses, and it is one of the potential treatment targets for NSCLC.

“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,” said John Tsai, MD, head of Global Drug Development and chief medical officer at Novartis, in a press release. “While 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. We share our gratitude and thanks to the CANOPY-1 study patients and clinical investigators for their partnership.”

The investigators are collaborating with Novartis on conducting further data analysis and will present the full dataset at an upcoming medical meeting. Novartis is continuing its evaluation of canakinumab in lung cancer and is applying findings to the overall lung cancer development plan.


Novartis top-line results for CANOPY-1 Phase III study support further evaluation of canakinumab in lung cancer [news release]. Novartis; October 25, 2021. Accessed October 25, 2021.