Ad hoc release according to article 17 MAR
Planegg/Munich, Germany, May 16, 2019
Ad hoc: Primary Endpoint of L-MIND, a Combination Study of Tafasitamab (MOR208) and Lenalidomide, has been met, Confirming Previously Published Activity
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) today announced results from the primary analysis (cut-off date November 30, 2018) of the ongoing single-arm phase 2 clinical trial known as L-MIND. The results overall confirm earlier reported interim data from this trial. L-MIND is designed to investigate the antibody tafasitamab (MOR208) in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are ineligible for high-dose chemotherapy and autologous stem cell transplantation. Tafasitamab is an investigational humanized Fc-enhanced monoclonal antibody directed against CD19 and is currently in clinical development in blood cancer indications.
The data reported today included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update are based on response rates assessed by an independent review committee for all 80 patients.
The primary endpoint, defined as best objective response rate (ORR) compared to published data on the respective monotherapies, has been met. The ORR was 60% (48 out of 80 patients), and the complete response (CR) rate was 43% (34 out of 80 patients). The median progression free survival (mPFS) was 12.1 months with a median follow-up of 17.3 months. The medium duration of response (mDoR) was 21.7 months. These results provide overall confirmation of the strong L-MIND data previously published at ASH in December 2018. These data showed an ORR of 58% with a CR rate of 33%; the mPFS was 16.2 months; data was assessed by the investigators.
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