nelis h schreef op 23 juni 2019 11:22:
van mei 2017:
More detail on MorphoSys and Lenalidomide
UPDATED: Better than CAR-T? Already prepping for a US launch, MorphoSys posts stellar DLBCL data to field against Novartis, Gilead
by john carroll — on May 17, 2019 07:27 AM EDT
Updated: 09:05 AM
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Already beavering away at building a US commercial operation, MorphoSys $MOR is now bearing down on Novartis and Gilead with a potential CAR-T killer soon to be put into the hands of US regulators.
David Trexler
The German biotech says its final cut of the data on their CD19-targeting antibody tafasitamab — or MOR208 — combined with lenalidomide crossed the finish line in a group of patients suffering from treatment-resistant DLBCL, a common form of non-Hodgkin lymphoma. The median on progression-free survival hit 12.1 months with a median duration of response at 21.7 months. The overall response rate among 80 patients was 60% with a jaw-dropping 43% complete response rate.
That’s the data that MorphoSys plans to hustle to regulators before the end of this year, with high expectations of being given the green light to roll out their antibody against the two main CAR-Ts — Yescarta and Kymriah from Gilead and Novartis. And they have good reason to hope for a quick OK. MOR208 was given a breakthrough therapy designation by the FDA, which has a clear track record of moving fast on new cancer drugs that can deliver credible data like this.
MorphoSys raised $208 million from a US IPO a year ago, expressly for the purpose of funding their transition to a commercial operation.
Malte Peters
Novartis won its approval for DLBCL a year ago after posting an overall response rate for 68 evaluable patients at 50% with a complete response rate of 32%. The pharma giant, though, has been bedeviled by manufacturing problems, allowing Gilead’s Yescarta to achieve greater market penetration in the CAR-T field. Now the German biotech plans to beat them both with an antibody that would require none of the elaborate prep work needed to customize a patient’s cells to fight this blood cancer.
MorphoSys recently hired David Trexler away from Merck KGaA’s US commercial team for Bavencio to lead the commercial operations in the US for this drug.
Winning here, won’t be easy. DLBCL is a popular disease target, and some of the majors are fielding their own promising late-stage programs with an eye to beating CAR-T. That list includes Roche’s polatuzumab vedotin in combination with bendamustine plus Rituxan. But with so many new drugs coming into play, the standard of care for DLBCL is changing. And MorphoSys is advancing its next trial for CLL as well as frontline use as it looks to become a player.
“As we move forward with our regulatory submission to the FDA of MOR208, we continue to build our commercial organization in the US,” MorphoSys CEO Simon Moroney told analysts earlier this week. “We’ve recruited all the main senior positions in support of our president, David Trexler, and are delighted with the excellent quality of management and high level of experience we’ve been able to attract.”
Malte Peters, the chief development officer of MorphoSys, had this to say about the data:
“We strongly believe we have a remarkable drug candidate and these data further support our plan to develop tafasitamab in combination with lenalidomide as a potential chemo-free treatment option for patients with r/r DLBCL. We remain highly committed to completing the submission of a BLA to the FDA by the end of this year.”
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