- Novartis' plans to repurpose a rare disease drug as a lung cancer treatment have yet to bear fruit, with the Swiss drugmaker reporting Monday that the therapy failed to meet its goal in a second Phase 3 study.
- Treatment with canakinumab, which is approved as Ilaris for several fever syndromes and uncommon forms of arthritis, did not slow tumor growth or extend survival when added to Merck & Co.'s immunotherapy Keytruda and chemotherapy and compared against those drugs alone, Novartis said.
- Novartis will continue studying canakinumab in lung cancer, however, noting "potentially clinically meaningful improvements" among certain subgroups of trial participants. Studies testing the drug alongside surgery, and before it, are ongoing. Results in the former setting are expected in 2023.
Novartis' testing of canakinumab, which works by curbing inflammatory signaling in cells, for the seemingly unrelated use in lung cancer stems from an intriguing 2011 finding in a large study called CANTOS.
Set up to test whether reducing inflammation with canakinumab could curb heart disease, CANTOS suggested the drug lessened the incidence and lethality of a common type of lung cancer.
Novartis has spent the years since that study chasing the implications of its results. The Food and Drug Administration in 2018 rejected the company's pitch to approve canakinumab as a treatment for reducing heart risk. And now the second trial designed to test canakinumab as a lung cancer treatment has come up short as well.
Novartis disclosed few details, except acknowledging that canakinumab did not significantly keep tumors from spreading or extend lives when added to Keytruda and platinum-based chemotherapy in previously untreated patients. Details from the Phase 3 study, called CANOPY-1, will be shared at an upcoming meeting, the company said.
The negative results follow data from another study, CANOPY-2, that showed no benefit to canakinumab when used later, as a treatment for lung cancer patients whose disease had progressed after chemotherapy and immunotherapy.
Neither trial tested canakinumab in a similar setting as CANTOS, however, which enrolled more than 10,000 people with heart disease who previously had a heart attack.
CANOPY-A, a study of canakinumab after surgery, more closely resembles the CANTOS study population, Novartis said. Results are expected in 2023 and could open a path for the drug in adjuvant use, if positive.
Novartis is also studying canakinumab in a Phase 2 trial testing the drug before surgery.
Correction: A previous version of this story mistakenly transposed the trial names CANOPY-1 and CANOPY-2.