AACR: Novartis up-and-comer capmatinib successfully fights lung cancer in the brain

Novartis' capmatinib has already scored an FDA priority review, setting it up for approval this year. (Novartis)

Novartis’ up-and-coming targeted therapy capmatinib has already proven it can benefit lung cancer patients with MET exon 14 skipping mutations, regardless of whether they’ve already tried other therapies. Now, the company is showing the drug can also battle tumors in the brain.

In a phase 2 study to be presented virtually at the American Association for Cancer Research annual meeting, capmatinib controlled disease in the brain in 12 of 13 evaluable patients with brain metastases, and it shrunk tumors in seven of those 13 patients. Four patients showed a complete response, meaning the drug erased all evidence of their brain lesions.

And the drug worked quickly, too. “These responses happened quite rapidly. All the patients responding in the brain had responded by the first set of scans,” Edward Garon, M.D., associate professor of medicine at the David Geffen School of Medicine at UCLA, said.

“Brain metastases are a significant problem in lung cancer,” so its efficacy there is “considered to be a nice feature …  of this agent,” he added.

While no drugs are approved to treat MET exon 14 skipping mutations, Garon cited Pfizer’s Xalkori as one that sees off-label use in those patients.

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But that drug “has had challenges with brain penetration” in its approved indications—lung cancer patients with ALK or ROS1 mutations—and while “you can’t extrapolate the response in the brain from one mutation to the other, there’s not a lot of reason there would be a difference in penetration into the brain,” Garon noted.

Of course, Novartis is hoping to change the lack of approved options for MET exon 14 skipping mutated patients as soon as possible.

The brain data come from the Geometry mono-1 lung cancer study, which previously showed capmatinib could provoke a response among 67.9% of previously untreated patients and 40.6% of those who had already received other therapies. That performance was enough to snag it a priority review from the FDA, which now expects to make an approval decision by August.

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If a green light does come, the Swiss drugmaker could beat rival Merck KGaA—whose own rival drug recently picked up an OK in Japan—to the U.S. market.

But that product, called Tepmetko, is not the only obstacle Novartis could face down the line. Prescription of capmatinib will require testing for MET exon 14 skipping mutations, which aren’t always included on testing panels that are considered comprehensive, Garon said.

Still, he expects to see that change “fairly rapidly,” especially considering the mutation “is not particularly rare.”

“When one looks at the scope of non-small cell lung cancer in general, of approximately 200,000 cases a year—to be 3% or 4% is, in fact, a very significant number of patients,” he said. “I think that it is common that when there is an effective therapeutic that is approved for a subset of patients, that subset becomes more defined.”