Novartis on Monday announced that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab (ACZ885) did not meet its primary endpoint of disease-free survival (DFS) versus placebo. The drug is an inhibitor of interleukin-1beta (IL-1β).
The trial was conducted in adult patients with stages II-IIIA and IIIB completely resected (R0) non-small cell lung cancer (NSCLC) and it did not give expected results.
No unexpected safety signals were observed and the findings from the trial will be presented at an upcoming medical meeting, the pharma major said in a statement on Monday.
“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, and we look forward to continuing to pursue new therapeutic options for people living with lung cancer, whose needs remain urgent and significant. We thank the patients and clinical investigators whose time and commitment made this research possible,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis in a statement.
In the trial, 1,382 patients were randomized 1:1 to canakinumab, 200 mg subcutaneously every three weeks, or a matching placebo for up to one year. Moreover, the patients completed standard-of-care adjuvant cisplatin-based chemotherapy and radiation therapy, if applicable, prior to randomisation.
Last week, Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma and it once again brought gene therapy’s safety to attention. According to reports, two children in Russia and Kazakhstan died about five to six weeks after receiving Zolgensma.