MorphoSys’ off-the-shelf rival to CAR-T approaches finish line with a speedy review
Gilead and Novartis may soon face the first rival to their CAR-T therapies.
The FDA has accepted the BLA for MorphoSys’s tafasitamab, an antibody that targets the same CD-19 antigen that CAR-T therapies do and looked in pivotal studies to be as or more effective. The agency gave it priority review and a PDUFA date of August 30, in-line with the company’s previous projections of a mid-2020 market launch.
In a Phase II trial on patients with a refractory form of the blood cancer DLBCL, tafasitamab showed a median progression-free survival rate of 12.1 months and median duration of response of 21.7 months. That translated to an overall response rate of 60% across 80 patients and a 43% complete response rate. Those numbers compare favorably with the pivotal trials for Gilead’s Yescarta therapy and Novartis’s Kymriah, which showed complete remission around 50% and 40%, respectively.
Critically, though, tafasitamab is far easier to make and deliver than its potential rivals. CAR-T therapies, custom-made from the extracted and then re-injected cells of each patient, have been consistently hampered by their lengthy and costly manufacturing process. Tafasitamab is an antibody that can be scaled, stored and taken, essentially, off-the-shelf when a patient needs it.
Those advantages attracted a $900 million co-commercialization deal with Incyte earlier this year, as the Jakafi drugmaker sought to fill in what’s become an increasingly dry R&D reservoir. MorphoSys has been preparing for a market launch for months, opening up new US headquarters in Boston and reshuffling their C-suite.
Even if approved, they are unlikely to remain the only off-the-shelf rival to CAR-T therapies for long. The market is likely to get heated, as Roche and Pfizer and biotechs such as Allogene and Cellectis advance therapies beyond the early stages.