The Phase 3 CANOPY-1 study did not meet its primary endpoints of OS and PFS in patients with previously untreated non-small cell lung cancer


Novartis Tower with surrounding buildings. (Credit: Novartis AG.)

Novartis announced that its canakinumab combination did not meet the primary endpoints of overall survival (OS) and progression-free survival (PFS) in Phase 3 CANOPY-1 trial.

In the study, patients with non-small cell lung cancer (NSCLC) were treated using canakinumab plus pembrolizumab and platinum-based doublet chemotherapy.

Earlier this year, the drug, in combination with chemotherapy agent docetaxel, has failed to improve survival in patients in Phase 3 Canopy-2 study.

Canakinumab is a human monoclonal antibody designed to selectively bind with human interleukin-1beta (IL-1β) with high affinity, blocking its interaction with its receptors.

The drug inhibits Pro-Tumour Inflammation (PTI) to enhance anti-tumour immune response, and reduce tumour cell proliferation, survival, and invasiveness and impair angiogenesis.

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 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 Swiss drugmaker, together with investigators, is continuing to evaluate canakinumab in lung cancer, both as a pre- and post-surgery treatment.

It is studying the drug in the ongoing CANOPY clinical trial programme, which includes Phase 3 CANOPY-A study, and Phase 3 CANOPY-N study.

Novartis said that canakinumab is a potential IL-1β inhibitor of the PTI pathway in NSCLC, and the study data supports further evaluation of the drug in lung cancer.

PTI enables tumour development by suppressing anti-tumour immune responses and is considered a potential indicator of cancer and targets in NSCLC.

The company said that it is developing additional potential PTI pathway inhibitors, including gevokizumab, and are currently at various stages of development.