CANOPY-1 Data Support Continued Study of Canakinumab in Select Populations of Patients With Non–Small Cell Lung Cancer

Although canakinumab, an investigational interleukin-1β inhibitor, plus pembrolizumab did not meet the primary end points for locally advanced metastatic non–small cell lung cancer in the CANOPY-1 trial, it could have potential in certain patient subgroups.

Although canakinumab (ACZ885) in combination with pembrolizumab (Keytruda) and platinum-based doublet therapy did meet the primary end points of the phase 3 CANOPY-1 trial (NCT03631199) in locally advanced or metastatic non–small cell lung cancer (NSCLC), investigators believe that further study of canakinumab is warranted in certain patient subgroups, according to a press release from Novartis.1

Findings from the study indicated that patients in a pre-specified subgroup with the inflammatory hs-CRP biomarker experienced clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS). It is also believed that data from the trial support further evaluation of canakinumab in earlier stages of lung cancer, either as an adjuvant or neoadjuvant therapy. However, the primary end points of OS and PFS in patients with locally advanced or metastatic disease were not met.

A full data analysis will be presented at an upcoming 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 at Novartis, said in the press release.

The randomized, double-blind CANOPY-1 trial enrolled 673 patients who were administered canakinumab every 3 weeks, and pembrolizumab at 200 mg every 3 weeks plus chemotherapy. To be enrolled on the trial, patients had to have histologically confirmed stage IIIB or stage IV NSCLC, a known PD-L1 status, and at least 1 measurable lesion by RECIST 1.1 criteria.

The CANOPY-1 trial is part of the overarching CANOPY clinical trial program, which includes other ongoing trials such as the phase 3 CANOPY-A trial (NCT03447769), assessing adjuvant canakinumab with stage IIIA and IIIB completely resected NSCLC, and CANOPY-N (NCT03968419), which is examining the efficacy of neoadjuvant canakinumab and pembrolizumab alone and combined in a population of patients with early-stage NSCLC.

Notably, patients in the CANOPY-A trial closely resemble those from the CANTOS trial (NCT01327846), which assessed the potential cardiovascular risk reduction associated with canakinumab. This was the first trial that showed that blocking the interleukin-1beta (IL-1β) inflammatory signal may potentially reduce lung cancer incidence and mortality.

The phase 3 CANOPY-2 (NCT03626545) also examined the efficacy of canakinumab in combination with docetaxel in the second- or third-line setting for a population of patients with advanced NSCLC, the results of which were previously reported at the 2021 European Society of Medical Oncology Congress. The trial notably did not meet its primary end point of OS.2

Canakinumab was designed as a human monoclonal antibody that binds with IL-1β. Evidence has suggested that canakinumab could inhibit pro-tumor inflammation, potentially eliciting an enhanced anti-tumor response, and helping to reduce tumor cell proliferation and invasiveness, increasing survival, and impairing angiogenesis.


1. 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 27, 2021.

2. Paz-Ares L, Goto Y, Lim WDT, et al. Canakinumab (CAN) + docetaxel (DTX) for the second- or third-line (2/3L) treatment of advanced non-small cell lung cancer (NSCLC): CANOPY-2 phase III results. Annal of Onc. 2021;32(suppl 5):S949-S1039. doi:10.1016/annonc/annonc729