Novartis' canakinumab falls short in phase 3 lung cancer trial

Novartis’ attempt to treat cancer with the anti-inflammatory drug canakinumab was always a long shot, but it’s nevertheless a disappointing feeling when things don’t work out.

Already approved for auto-inflammatory diseases such as active systemic juvenile idiopathic arthritis under the brand name Ilaris, Novartis is testing canakinumab to see if inhibiting the IL-1beta pathway can protect against cancer too.

The rationale came from the CANTOS trial where patients treated with canakinumab in atherosclerotic disease appeared to have a reduced risk of lung cancer mortality, in findings presented at the 2017 European Society of Cardiology congress.

But Novartis said the phase 3 CANOPY-2 trial did not meet its primary endpoint of overall survival in patients with advanced or metastatic non-small lung cancer, in second or third line.

The trial was conducted in 237 adults with locally advanced or metastatic NSCLC whose disease progressed while on or after previous platinum chemotherapy or PD-1 or PD-L1 immunotherapy.

Patients were treated either with canakinumab and docetaxel chemotherapy, or with docetaxel alone.

A team of analysts from Jefferies had a “low conviction” that the phase 3 CANOPY-2 in second-line metastatic non-small cell lung cancer would work, especially as the first-line CANOPY 1 trial passed an interim analysis but fell short of efficacy criteria for early stopping.

Jefferies is predicting $2bn in potential peak sales in cancer worldwide, with the majority from potential use in earlier stage disease, with a success probability of 40%.

The analysts are more hopeful about the potential of canakinumab as a potential adjuvant treatment in combination with checkpoint inhibitor immunotherapy.

Novartis noted in its statement the other ongoing studies of canakinumab in NSCLC – these include the phase 3 CANOPY-1 trial testing it in combination with Merck & Co’s PD-1 immunotherapy Keytruda (pembrolizumab) in first line disease and CANOPY-N, a phase 2 trial testing canakinumab and Keytruda in resectable NSCLC before surgery.

A final readout from CANOPY-1 is expected later this year, although CANOPY-N is not expected to produce data that could be used for a filing.