Novartis lung cancer drug fails to meet endpoints in Phase III trial

By Pankaj Singh

Renowned pharmaceutical company, Novartis has recently disclosed that its lung cancer drug ‘canakinumab’ has failed again in meeting its goal of improving overall survival rates in lung cancer patients and preventing progression-free survival.

The Swiss-based company stated that its Canopy-1 Phase III study could not meet its primary results when patients were being treated for formerly untreated locally advanced or metastatic NSCLC (non-small cell lung cancer) combined with pembrolizumab plus platinum-based doublet chemotherapy.

The announcement serves as a setback for Novartis after the drug, combined with chemotherapy agent docetaxel, was unable to meet endpoints earlier this year to advance survival in subjects in its Canopy-2 Phase III study.

Novartis says that it would constantly inspect to determine if canakinumab would work as both an after- and pre-surgery treatment.

John Tsai, Novartis' Head of Global Drug Development and a Chief Medical Officer, said that CANOPY-1 delivers critical perceptions into the conduct of this overwhelming disease, and they will continue to investigate the data and assumptions, as well as their possible clinical implications.

Even though this trial could not offer the benefit the firm hoped for all the patients, the complete CANOPY-1 study still motivates them to support the commitment to endure studying canakinumab in lung cancer.

As of now, subject enrolment is underway in the CANOPY clinical trial programme, including a Phase III CANOPY-A trial and a Phase II CANOPY-N trial.

Basically, CANOPY-A looks at canakinumab as an adjuvant treatment after surgery, whereas CANOPY-N looks at it as a neoadjuvant treatment before surgery.

Patients that are enrolled in the CANOPY-A trial will reflect on the CANTOS study conducted on patients earlier compared to those in the CANOPY-1 trial. The CANTOS study shows that blocking the IL-1β inflammatory signal could potentially reduce the incidence and mortality of lung cancer.

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