Novartis nabs priority review for a blockbuster-to-be aimed at NSCLC niche — delighting Incyte execs
Incyte finally has some good news to share about one drug it’s discovered that’s not Jakafi — albeit one that doesn’t belong to it anymore.
FDA regulators have accepted capmatinib, an orphan and “breakthrough” MET inhibitor, for priority review. The honor technically goes to Novartis, which licensed worldwide development and commercialization rights to the drug back in 2009.
But that didn’t stop Incyte from bragging about it in a release, reminding investors that if everything goes well, it’s eligible for $500 million-plus in milestones as well as royalties up to 14% of global sales.
Shaving four months off the review timeline — assuming there aren’t hiccups — helps ensure that Novartis can score an approval within this year. The pharma giant had designated capmatinib (formerly INC280) as one of four major launches of 2020, predicting a blockbuster future for a drug initially aimed at a subtype of non-small cell lung cancer.
NSCLC patients who harbor a MET exon-14 skipping mutation currently have no approved targeted therapy. A Novartis-sponsored Phase II trial showed that capmatinib induced an overall response rate of 67.9% among treatment-naïve patients (duration of response 11.14 months) and 40.6% among previously treated ones (DOR 9.72 months).
Those 97 patients had EGFR wildtype, ALK-negative tumors, and took 400 mg capmatinib tablets twice a day.
“METex14 mutations occur in 3-4% of newly diagnosed advanced NSCLC cases and is a recognized oncogenic driver,” Novartis noted in a statement.
Merck KGaA and Pfizer also angling for this untapped niche; both have been granted breakthrough therapy designations, though theirs only cover second-line therapy following platinum-based chemo. While tepotinib from the German drugmaker was engineered as a selective MET inhibitor, the drug Pfizer has put forward is Xalkori, originally targeted at ALK and ROS1 mutations.
Meanwhile, in China, Chi-Med is also testing AstraZeneca’s MET inhibitor, savolitinib, in a Phase II registrational trial among patients who have progressed following prior systemic therapy or are unable to receive chemo.
A companion diagnostic will likely be key to the adoption of any of these treatments. Novartis has teamed up with Foundation Medicine — now a Roche subsidiary — to include tumor tissue and liquid biopsy diagnostics on its flagship products.