Trial Assessing Novel Drug in Patients With Previously Treated Non-Small Cell Lung Cancer Fails to Meet its Goal of Improving Survival

The phase 3 CANOPY-2 trial failed to meet its main goal of improving overall survival in patients with locally advanced or metastatic non–small cell lung cancer whose disease progressed on or after prior platinum-based chemotherapy and treatment with PD-1/L1 inhibitor therapy, according to Novartis.

The trial was designed to assess the effectiveness of the novel interleukin-1β inhibitor ACZ885 (canakinumab) plus the chemotherapy docetaxel compared with placebo in this patient population.

“While results from the CANOPY-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other lines of therapy, these data give us valuable insights into IL-1β inhibition,” said Novartis’ head of global drug development and chief medical officer Dr. John Tsai in a news release. “Ongoing phase 3 studies in non-small cell lung cancer continue, evaluating canakinumab in earlier treatment settings.”

Novartis noted in the release that full data from the study will be presented at a future medical meeting.

The ongoing phase 3 trials include the CANOPY-1 and CANOPY-A trial. The CANOPY-1 trial has enrolled 673 patients to measure the effect Keytruda (pembrolizumab) plus platinum-based doublet chemotherapy with or without ACZ885 has on overall survival and progression-free survival in previously untreated locally advanced or metastatic nonsquamous and squamous patients.

The CANOPY-A trial is actively recruiting patients, with a target enrollment of 1,500 individuals. The goal of the trial, according to Novartis, is to assess ACZ885’s effect on disease-free survival in patients with stage 2, stage 3a and certain stage 3b disease, compared to placebo.

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