- A regimen of the anti-inflammatory drug canakinumab and chemotherapy didn't help lung cancer patients live longer than chemotherapy alone when used as a second-line treatment, Novartis said Tuesday. The announcement is a another sign that the Swiss big pharma may not be able to expand use of the drug beyond rare diseases, for which it is sold as Ilaris.
- Novartis believed the drug could help lung cancer patients based on the findings of a large cardiovascular trial called CANTOS, which hinted that canakinumab could reduce both new diagnoses and deaths from the disease. The drug blocks a protein associated with both inflammation and cancer progression.
- Despite the setback, Novartis still hopes canakinumab can play a role in lung cancer. Two more trials are underway, including one testing the drug alongside immunotherapy and chemotherapy in newly diagnosed patients.
Novartis markets canakinumab as Ilaris in a group of rare, auto-inflammatory disorders driven by the protein interleukin-1 beta. Priced at $73,000 a year, the injected biological had sales of $900 million in 2020.
While Ilaris was launched in 2009 for uncommon disorders, the Swiss group has since followed scientific hypotheses showing the drug might help curb inflammation seen in heart disease, which is much more prevalent. It initiated the 11,000-patient CANTOS trial in 2011 to find out if the drug could prevent future cardiovascular events in people who have had heart attacks and are at risk of subsequent complications.
CANTOS did show that, compared to placebo, a 150 milligram dose of canakinumab once every three months reduced cardiovascular events. But the data did have its flaws, and when Novartis delivered the results to the Food and Drug Administration, the agency rejected its application. The company later withdrew a similar filing with regulators in Europe.
As a heart disease drug meant for a much large population than Ilaris is cleared to treat, canakinumab would have raised some tricky pricing questions for Novartis. Insurers almost certainly would not have paid the same price in heart disease as they do for the drug in orphan diseases, which could have forced the company to sacrifice revenue in those indications.
However, CANTOS provided another avenue to pursue. New lung cancer cases and deaths were reduced in the patients who took canakinumab — a setting where the drug's price would be under less pressure. Novartis ramped up multiple tests, with a 237-patient study called CANOPY-2 the first to produce results so far.
The data announced Tuesday, however, cast doubt on this strategy. Patients in the trial had progressed after receiving a regimen of Merck & Co.'s immunotherapy Keytruda and chemotherapy, the standard of care for a majority of patients with the disease. They then received either canakinumab and chemotherapy or chemotherapy alone. Survival was similar in both groups, Novartis reported.
Two other Phase 3 trials are still underway, however. CANOPY-1 tests canakinumab alongside the Keytruda-chemotherapy combination in newly diagnosed patients, while CANOPY-A will determine whether it can prevent a relapse after surgery and chemotherapy. CANOPY-1 should produce results in 2021, while CANOPY-A is due to read out in 2023.