3rd time is not always the charm: Novartis' Ilaris flops⁠—again⁠—in lung cancer

Novartis has been trying for years to secure a lung cancer approval for its inflammation drug Ilaris, but the company just can’t seem to get it right. The effort suffered another setback Monday as the drugmaker revealed that Ilaris has failed in a third lung cancer trial.

In a late-stage trial called Canopy A, Ilaris, also known as canakinumab, fell short on its primary endpoint of extending disease-free survival versus placebo. The trial tested the drug against placebo in 1,382 patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer.

Despite the company’s disappointment, Novartis is still pursuing “new therapeutic options” for people living with lung cancer, Jeff Legos, Executive Vice President and global head of oncology and hematology development, said in a statement.

“Every trial generates scientific evidence that supports future research and development,” Legos said.

Novartis plans to share the full trial findings at an upcoming medical meeting.

It’s not the drug's first failed study in lung cancer. Last October, Ilaris plus Merck’s Keytruda and platinum-based chemotherapy didn’t extend the lives of newly diagnosed NSCLC patients, failing to show a benefit in slowing tumor progression over an immunotherapy-chemo combo.

That flop came after another trial failure in March, when the drug, combined with chemotherapy, didn’t beat solo chemo at extending the lives of previously treated NSCLC patients. At the time, the company’s chief medical officer John Tsai, M.D., said that despite the trial failure, the data provides “valuable insights into IL-1 beta inhabitation.”

The drug has a number of approvals in several rare inflammatory diseases. Last year, the drug pulled in $1.06 billion, a 21% increase from 2020. Analysts have said a lung cancer approval could be worth $2 billion in annual sales.

Aside from the lung cancer pursuit, Novartis also tried to gain an FDA nod for Ilaris in certain patients who suffered a prior heart attack. The FDA rejected the filing in 2018, citing insufficient data.