2:51 PM
Mar 13, 2018
 |  BC Extra  |  Clinical News

MorphoSys planning BLA for DLBCL candidate on Phase II data

MorphoSys AG (Xetra:MOR; Pink:MPSYY) said it discussed with FDA the possibility of expedited regulatory submission and approval for its MOR208 to treat relapsed or refractory diffuse large B cell lymphoma "based primarily" on data from the Phase II L-MIND trial in the indication. The company, which plans to submit a rolling BLA to FDA in 2H19 for MOR208, reported updated data from L-MIND on Tuesday.

Among 68 evaluable patients ineligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT) in the open-label trial, IV MOR208 plus Revlimid lenalidomide led to a preliminary 12-month progression-free survival (PFS) rate of 50.4%. Preliminary median PFS has not yet been reached. MOR208 plus Revlimid led to an overall response rate (ORR) of 49%, including a complete response rate of 31%. Median time to response was 1.8 months and median time to complete response was 3.6 months.

The Fc-optimized human mAb against CD19 has breakthrough therapy designation in the U.S. in combination with Revlimid to treat non-transplant eligible patients with relapsed or refractory DLBCL. MOR208 is also in the Phase II/III B-MIND trial in combination with Treanda bendamustine to treat relapsed or refractory DLBCL.

MorphoSys has exclusive, worldwide rights to develop and commercialize MOR208 from Xencor Inc. (NASDAQ:XNCR) under a 2010 deal (see BioCentury Extra, June 28, 2010).

Separately, the company reported its 2017 earnings with revenues of €66.8 million ($80.2 million), beating the consensus estimate of €64.8 million ($77.8 million). MorphoSys also guided for 2018 revenues between €20-€25 million, below the consensus estimate of €38.2 million.

MorphoSys gained €4.40 to €87.25 on Tuesday. Xencor was off $0.52 to $33.26.

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