Novartis Phase III study into canakinumab does not meet primary endpoint
pharmafile | October 25, 2021 | News story | Sales and Marketing |
Novartis have announced that their CANOPY-1 Phase III study, which evaluated the efficacy of canakinumab, did not meet its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study compared patients treated with canakinumab (ACZ885), in combination with pembrolizumab plus platinum-based doublet chemotherapy, with patients receiving placebo in addition to this same combination.
The trial data showed clinically meaningful improvements in both PFS and OS, in pre-specified subgroups of patients based on the baseline inflammatory biomark, hs-CRP, as well as other biomarker-defined subgroups.
Canakinumab is a potential first-in-class interleukin-1beta (IL-1β) inhibitor of the Pro-Tumour Inflammation pathway (PTI) in NSCLC. PTI enables tumour development by driving cancer-causing processes and suppressing anti-tumour immune responses.
“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, Novartis.
“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 CANOPY clinical trial programme will continue with CANOPY-A, a Phase III study investigating canakinumab as an adjuvant therapy (after surgery), and CANOPY-N, a Phase II study in the neoadjuvant setting (before surgery).
Novartis remains committed to working alongside the scientific and medical communities to create innovative treatments for lung cancer.
Lina Adams
