A phase 3 trial evaluating canakinumab in combination with docetaxel for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) did not meet its primary end point, according to Novartis.

Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to interleukin-1beta (IL-1β). Early data suggest that by neutralizing IL-1β, canakinumab inhibits pro-tumor inflammation thereby enhancing anti-tumor immune responses.

The randomized, double-blind, placebo-controlled CANOPY-2 trial (ClinicalTrials.gov: NCT03626545) investigated the efficacy and safety of canakinumab plus docetaxel in 237 adults with locally advanced or metastatic NSCLC whose disease progressed while on or after previous platinum-based chemotherapy and PD-L1 inhibitor immunotherapy. Patients were randomly assigned to receive canakinumab plus docetaxel or docetaxel alone.

Results showed that treatment with canakinumab plus docetaxel did not meet the primary end point of overall survival. Study data will be analyzed and are expected to be submitted for presentation at an upcoming medical meeting.

“While results from the CANOPY-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other lines of therapy, these data give us valuable insights into IL-1β inhibition,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis.

Novartis will continue evaluating canakinumab in the ongoing phase 3 CANOPY-1 (ClinicalTrials.gov: NCT03631199) and CANOPY-A (ClinicalTrials.gov: NCT03447769) trials for the treatment of NSCLC in a first-line and adjuvant therapy setting, respectively. 


Novartis provides update on phase III study evaluating canakinumab (ACZ885) as second or third-line treatment in combination with chemotherapy in non-small cell lung cancer. [press release]. Basel, Switzerland: Novartis Pharma AG; March 9, 2021.