Phase 3 CANOPY-2 Trial Failed to Meet Primary Endpoint for Second, Third-line NSCLC

By Adam Hochron

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A phase 3 clinical trial evaluating canakinumab as a second or third-line treatment for non-small cell lung cancer failed to meet its primary endpoint of overall survival, according to a release from the manufacturer. 

The CANOPY-2 trial evaluated patients with advanced or metastatic NSCLC whose cancer progressed during or after previous treatments. Patients enrolled in the trial were treated with a combination of canakinumab and docetaxel as a chemotherapy agent. 

“While results of 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 John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis. 

Although the study did not meet its primary endpoint, the release noted that there are currently two ongoing phase 3 CANOPY trials evaluating canakinumab in first-line and adjuvant settings. The phase 3 CANOPY-1 study evaluating canakinumab in combination with immunotherapy and chemotherapy is expected to report results by the end of the year. 

Additionally, the phase 3 CANOPY-A study is studying canakinumab as an adjuvant therapy and is expected to enroll around 1,500 patients. 

The release noted that the CANOPY program was started after successful findings during the phase 3 CANTOS trial, which evaluated canakinumab as a secondary prevention measure for cardiovascular events after patients suffered a heart attack. The manufacturer said patients in that trial were also at high risk for inflammatory cancers due to several factors, including age and smoking history. 

Full results from the CANOPY-2 trial are expected to be presented at a future medical conference. 


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