Novartis: Phase III CANOPY-2 Trial Of Canakinumab Fails To Meet Primary Endpoint

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Novartis AG (NVS) Tuesday announced that the Phase III CANOPY-2 study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1ß), in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival.

The Phase III trial was in 237 patients with advanced or metastatic non-small cell lung cancer or NSCLC whose cancer progressed while on or after previous treatments.

The trial evaluated canakinumab as second or third-line treatment in combination with chemotherapy in non-small cell lung cancer.

According to the company, the CANOPY clinical trial program is designed to help answer critical questions about the role of interleukin-1 beta (IL-1ß) in pro-tumor inflammation in lung cancer. Multiple clinical trials are investigating canakinumab in different stages of disease using distinct treatment combinations.

Novartis said 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.

John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis, said, “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-1ß inhibition.”

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.

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