Novartis' late-stage blockbuster push gets major boost with another 'breakthrough' for MET therapy
Novartis has just received a major boost in its race with Pfizer to develop a therapy for a notoriously treatment-resistant cancer and get one of its projected 2020 blockbuster drugs to market.
The FDA has expanded Novartis’ “breakthrough therapy” designation for capmatinib (INC280) to treat a particularly aggressive form of non-small cell lung cancer, MET exon14 skipping-mutated NSCLC. Pfizer achieved breakthrough therapy designation to treat the same disease with Xalkori (crizotinib), which is already in use to treat less-resistant forms of NSCLC, in March of 2018. No known treatment is currently approved for the ailment.
Novartis’ designation, however, is now broader than Pfizer’s, covering both treatment-naive patients and those already treated with platinum-cell chemotherapy. Pfizer’s was only for those already treated with platinum-level chemotherapy, as of their 2018 announcement. Capmatinib has also attained orphan drug status.
Originally discovered by Incyte and licensed to Novartis in 2009, capmatinib is an orally bioavailable inhibitor that works by binding to the c-Met cells that are altered and drive tumor growth in a small number – around 5%, per the NIH – of NSCLC cancer patients. It is one of several inhibitors that has gained traction in recent years as a viable treatment for this therapy-resistant form of lung cancer, including Mirati Therapeutics’s glesatinib and Merck KGaA’s tepotinib.
Novartis CEO Vas Narasimhan included the therapy as one of seven potential blockbusters the company was hoping to bring on to the market in 2020. More broadly, the company has talked up its gene and cell therapies, projecting this week that they will account for 15-20% of its sales in the midterm, or nearly $50 billion per year – up from the pennies they currently account for.
The rise has already begun with the blood cancer therapy Kymriah and the congenital blindness treatment Luxturna, both of which run into the hundreds of thousands of dollars in price per patient.
Already this year, one of its projected blockbusters, MS drug Arzerra, cleared two trials to put it on pace for a 2020 launch, seizing headlines from the flop of its star cardiac drug Entresto.
If Novartis launches capmatinib, Incyte stands to earn over half a billion dollars in milestone payments and royalties.
Breakthrough status came after data from Novartis’ international, 97-person GEOMETRY mono-1 study showed what the company called “promising” results. Data showed a 68% response rate from treatment-naive patients and 40.6% from those previously treated. Seven of 13 patients also saw intracranial activity, including instances of complete brain lesion healing.