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Novartis provides update on Phase III study evaluating canakinumab as second or third-line treatment in combination with chemotherapy in NSCLC.

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Published:10th Mar 2021
Novartis announced the Phase III CANOPY-2 study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1beta), in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival (OS). The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings. Novartis and CANOPY-2 investigators will analyze the study data and are expected to submit its findings for presentation at an upcoming medical meeting. CANOPY-1, a Phase III study evaluating canakinumab in combination with immunotherapy and chemotherapy, is expected to report final results before the end of the year . CANOPY-A , another Phase III study, is investigating canakinumab as an adjuvant therapy and has enrolled more than 950 patients to date and is expected to enroll a total of 1,500 patients . About the CANOPY program : 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 (CRP greater than 2 mg/L). Patients in the CANTOS trial were also 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 non-small cell lung cancer (NSCLC). • CANOPY-1 (NCT03631199) is a Phase III trial evaluating canakinumab as a first-line treatment for locally advanced or metastatic NSCLC in combination with pembrolizumab and platinum-based doublet chemotherapy. • CANOPY-2 (NCT03626545) is a Phase III trial investigating the role of canakinumab in combination with the chemotherapy agent docetaxel in second- or third-line therapy versus docetaxel alone in NSCLC. Part 1 of the CANOPY-2 trial – a safety run-in study to determine the appropriate dosage, was previously presented at ASCO 2019. Part 2 of the trial, reported now evaluated overall survival (OS). • CANOPY-A (NCT03447769) is a Phase III trial studying canakinumab in the adjuvant setting, following surgical resection and cisplatin-based chemotherapy. The adjuvant study is designed to determine if treatment with canakinumab can prevent cancer relapse • CANOPY-N (NCT03968419) is a non-registrational Phase II neoadjuvant trial evaluating canakinumab in combination with pembrolizumab among patients with resectable NSCLC prior to their planned surgery.
Condition: Non Small Cell Lung Cancer
Type: drug

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