Novartis cancer drug falls short of primary endpoints at Phase 3 trial

SWITZERLAND – Novartis has announced that the primary endpoints of a Phase 3 trial evaluating canakinumab drug failed in its second attempt, missing targets to improve overall survival rates for lung cancer patients and arrest the progression of free-survival of people with the condition.

According to the Swiss pharmaceutical company, the CANOPY-1 trial did not show statistical significance in overall survival or progression-free survival, which is the amount of time a patient can live without the disease progressing.

Canakinumab failed to meet its primary endpoints in the CANOPY-1 Phase III trial when combined with Merck’s checkpoint inhibitor Keytruda (pembrolizumab) plus platinum-based doublet chemotherapy in non-small cell lung cancer (NSCLC).

The trial evaluated canakinumab, a monoclonal antibody, in combination with chemotherapy for patients with non-small cell lung cancer.

The trial specifically failed to meet the primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients receiving the combination therapy when compared to the placebo cohort that received Keytruda plus platinum-based doublet chemotherapy in patients with previously untreated locally advanced or metastatic NSCLC.

The study’s statistical significance for those endpoints was not met. Nonetheless, according to the company, the study showed potentially clinically meaningful improvements in PFS and OS in pre-specified subgroups based on the baseline inflammatory biomarker, high sensitivity-C reactive protein (hs-CRP), and other biomarker-defined subgroups.

The company believes this validates the drug’s continued research in lung cancer.

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, M.D., 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.”

Canakinumab is a human monoclonal antibody that targets human interleukin-1 beta (IL-1B) and neutralizes its activity.

Data suggests this can inhibit Pro-Tumor Inflammation (PTI) from improving anti-tumor immune response and decreasing tumor cell proliferation, survival, invasiveness, and impairing angiogenesis.

The drug was initially developed to treat atherosclerotic disease, but the company discovered in 2017 that it also reduced the risk of dying from lung cancer.

Novartis and the industry are investigating whether drugs that affect the PTI pathway in NSCLC can be beneficial. Novartis is also conducting a Phase I trial with gevokizumab, an anti-IL-1B antibody.

Novartis signed an initial agreement with Pfizer and BioNTech late last week to expand its fill-and-finish activities for the companies’ COVID-19 vaccine.

Novartis will make use of its sterile manufacturing facilities at the Novartis Technical Operations site in Ljubljana, Slovenia. It anticipates filling at least 24 million doses by 2022.

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