Novartis: Phase III CANOPY-A Study Evaluating Canakinumab Fails To Meet Primary Goal

Swiss drug major Novartis AG (NVS) announced Monday that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab (ACZ885) did not meet its primary endpoint of disease-free survival or DFS versus placebo in non-small cell lung cancer.

The trial of ACZ885, an inhibitor of interleukin-1beta (IL-1ß), was in adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer or NSCLC.

No unexpected safety signals were observed.

The company will present the findings from the trial at an upcoming medical meeting.

Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human IL-1ß and inhibits IL-1ß activity by blocking its interaction with its receptors.

Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular CANTOS trial. The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack.

The company noted that patients in the CANTOS trial also were at high risk for inflammatory cancers like lung cancer due to advanced age, smoking history, and other clinical risk factors.

Based on these findings, Novartis launched three large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in NSCLC.

Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis, said, “We made an investment in the CANOPY program based on signals of reduced lung cancer incidence and mortality observed in the CANTOS study. These positive signals supported the study of canakinumab as adjuvant treatment for early lung cancer. While we are disappointed CANOPY-A did not show the benefit we hoped for, every trial generates scientific evidence that supports future research and development..”

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