Novartis beats Merck KGaA to U.S. finish line with targeted lung cancer drug Tabrecta

Novartis and Merck KGaA have been racing their targeted lung cancer drugs to markets around the world, but it’s the Swiss drugmaker that’s won the first FDA green light.

The agency Wednesday approved Tabrecta (capmatinib) for metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping mutations, regardless of whether they’ve tried other therapies. The drug will bear a list price of $17,950 for a 28-day supply, which is "comparable to the cost of other existing therapies prescribed for this aggressive form of lung cancer," a company spokesperson said by email.

Just 3% to 4% of newly diagnosed advanced NSCLC patients harbor the mutation, but they represent “a unique patient population that tends to be on the older side and often frail due to other comorbidities. It’s an opportunity to really fill a major unmet medical need,” Jeff Legos, senior vice president and global program head, said ahead of the OK.

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They also represent a patient pool that rival Merck KGaA is hoping to capture with Tepmetko, another therapy targeting MET exon 14 skipping mutations. The drug grabbed its first global approval in March with a nod in Japan, but isn't yet approved in the U.S.

The FDA based its Tabrecta decision on phase 2 data showing it could trigger a response in 68% of patients, with the majority of those patients responding for more than a year, Legos said.

Patients who had yet to try other therapies generally did better on the drug, which “just reinforces the importance of diagnosing these patients early and treating them with first-line capmatinib to really get the maximum potential benefit of this targeted therapy," Legos said.

But testing for the mutation isn’t nearly as widespread as Novartis would like. It’s usually done as part of next-gen sequencing for lung cancer, which only about 35% of U.S. patients receive up front, said Ameet Mallik, EVP at Novartis Oncology U.S.

Some doctors will test for other mutations—including ALK and EGFR—first and place patients on a PD-1/PD-L1 regimen if patients test negative. They might do next-gen sequencing after that, Mallik said.

The problem is, “these are patients who really have a poor prognosis,” and a lot of them “don’t even make it to future lines” of therapy, he pointed out.

“We think … testing should be more up front so that a physician can make the best decision for the patient,” he said, adding that Novartis is advocating for the Centers for Medicare & Medicaid Services to rethink reimbursement policies that “sometimes get in the way of testing.”

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Meanwhile, Novartis has big plans for Tabrecta that go beyond the monotherapy realm—and beyond MET exon 14 skipping mutations. "The potential for this to be used in combination with anti-PD-1 ... would open it up to a much broader population than the 3% to 4%" of lung cancer patients for whom it's currently cleared, Mallik said.

And those studies are "already up and running," Legos noted. The Big Pharma is testing Tabrecta alongside Bristol Myers Squibb's immuno-oncology giant Opdivo and its own investigational EGFR inhibitor in a phase 2 study, for example.

"This is just the beginning," Legos said.