Canakinumab did not meet the primary endpoint of disease-free survival in adult patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer.
Novartis recently announced that canakinumab (ACZ885) did not meet the primary endpoint of disease-free survival (DFS) in adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected non-small cell lung cancer (NSCLC) in the CANOPY-A phase 3 trial, which compared canakinumab with a placebo.
“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,” said Jeff Legos, executive vice president, global head of Oncology and Hematology Development, Novartis, in a press release.
More than 2 million people are diagnosed with lung cancer each year. It is they most deadly cancer in the world and divided into 2 main subtypes: small cell lung cancer (SCLC) and NSCLC. Nearly 85% of lung cancer diagnoses are for NSCLC, and 30%-55% of these cases are recurrent.
CANOPY-A was a multicenter, randomized, double blind trial evaluating the safety and efficacy of canakinumab as a secondary treatment for patients with NSCLC stage II-IIIA and IIIB, some of whom completed cisplatin-based chemotherapy and radiation therapy prior to the trial. Researchers randomized 1382 participants in a 1:1 ratio with patients administered either a 200 mg injection of canakinumab every 3 weeks for 1 year, or an equal dose of the placebo for 1 year.
Canakinumab was preliminarily suggested to suppress pro-tumor Inflammation—which drives cancer-causing activity and suppresses anti-tumor immune response— by engaging antitumor immune response, reducing tumor cell proliferation, survival, and invasiveness, and impairing angiogenesis.
Canakinumab was first evaluated in the CANTOS trial and was shown to be an effective preventative treatment against cardiovascular events for patients who had experienced a heart attack. Due to numerous risk factors, patients also had a high risk of developing lung and other inflammatory cancers, prompting researchers to launch CANOPY and investigate the drug as an NSCLC treatment.
Researchers found no unexpected safety signals after the trial. They will present their findings at an upcoming medical meeting.
“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, and we look forward to continuing to pursue new therapeutic options for people living with lung cancer, whose needs remain urgent and significant,” Legos said in the release. “We thank the patients and clinical investigators whose time and commitment made this research possible.”
Novartis. Novartis provides update on Phase III CANOPY-A study evaluating canakinumab as adjuvant treatment in non-small cell lung cancer. Novartis website. August 15, 2022. Accessed on August 16, 2022. https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-canopy-study-evaluating-canakinumab-adjuvant-treatment-non-small-cell-lung-cancer