Novartis has announced that its interleukin-1beta (IL-1β) inhibitor canakinumab failed to hit the primary endpoint of overall survival in a Phase III non-small cell lung cancer (NSCLC) trial.
The CANOPY-2 study evaluated canakinumab in combination with docetaxel chemotherapy among 237 adults with locally advanced or metastatic NSCLC, whose disease had progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy.
Despite the disappointing results in this trial, Novartis said that two additional Phase III CANOPY trials will continue – evaluating canakinumab in the first-line and adjuvant settings.
The CANOPY-1 trial, which is evaluating canakinumab in combination with immunotherapy and chemotherapy, is expected to report final results before the end of 2021.
Meanwhile, the CANOPY-A trial, which is investigating canakinumab as an adjuvant therapy, has currently enrolled over 950 patients and is expected to enrol a total of 1,500 participants.
“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 John Tsai, head of global drug development and chief medical officer at Novartis.
“Ongoing Phase III studies in non-small cell lung cancer continue, evaluating canakinumab in earlier treatment settings. We sincerely thank the patients and clinical investigators involved in the CANOPY-2 study for their partnership,” he added.
Novartis, along with the CANOPY-2 trial investigators, will analyse the study data and also plan to submit the findings for presentation at an upcoming medical meeting.