Novartis has reported that its antibody canakinumab (ACZ885) in combination with pembrolizumab plus platinum-based doublet chemotherapy failed to meet primary goals in the Phase III CANOPY-1 clinical trial in non-small cell lung cancer (NSCLC) patients.
A human monoclonal antibody, canakinumab attaches to interleukin-1beta and hinders its interaction with receptors.
The double-blind, placebo-controlled Phase III trial assessed canakinumab as first-line therapy, along with platinum-based doublet chemotherapy and pembrolizumab, to treat priorly untreated locally advanced or metastatic NSCLC.
Overall survival (OS) and progression-free survival (PFS) were the primary goals of the trial.
Findings showed that the trial did not demonstrate the statistically significant OS and PFS endpoints in subjects who received canakinumab combination treatment versus placebo plus pembrolizumab and platinum-based doublet chemotherapy.
However, pre-specified subgroups of subjects based on the baseline inflammatory biomarker, hs-CRP, and other biomarker-defined subgroups exhibited a trend of possibly clinically meaningful advances in PFS and OS.
When coupled with pembrolizumab and platinum-based chemotherapy, canakinumab did not show any new safety signals in the trial.
These results back further analysis of canakinumab for lung cancer.
Novartis Global Drug Development head and chief medical officer John Tsai said: “CANOPY-1 provides critical insights into the treatment of this devastating disease, and we will continue to analyse the data and conclusions, as well as their potential clinical implications.
“While this trial did not confirm the benefit for all patients we hoped for, we are energised by the overall CANOPY-1 findings as they support our commitment to continue studying canakinumab in lung cancer.”
The CANOPY clinical trial programme is currently progressing with a Phase III CANOPY-A trial and Phase II CANOPY-N trial, with subject enrolment underway.
CANOPY-A is assessing canakinumab as an adjuvant treatment following surgery while CANOPY-N is evaluating the antibody in the neoadjuvant setting prior to surgery.
Last month, the US Food and Drug Administration granted fast track designation to Novartis’ LNA043 for knee osteoarthritis treatment.