On May 16, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported results from the primary analysis (cut-off date November 30, 2018) of the ongoing single-arm phase 2 clinical trial known as L-MIND (Press release, MorphoSys, MAY 16, 2019, View Source [SID1234536423]).

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The primary endpoint, defined as best ORR compared to published data on the respective monotherapies, has been met. The ORR was 60% (48 out of 80 patients), and the CR rate was 43% (34 out of 80 patients). The mPFS was 12.1 months with a median follow-up of 17.3 months. The mDoR was 21.7 months. These results provide overall confirmation of the strong L-MIND data previously published at ASH (Free ASH Whitepaper) in December 2018.

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.

"We are delighted to see that the overall results fom the primary analysis of our L-MIND trial have confirmed the strong data we had presented at ASH (Free ASH Whitepaper) in 2018", commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "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 end of this year."

"The results fom the primary analysis are very encouraging. We are particularly pleased to see such a high complete response rate and a prolonged response duration, which is unsual in this population of relapsed or refractory DLBCL. If approved, given its safety profile, tafasitamab has the potential to become a new treatment option to improve quality of life and outcome for patients with this disease", says Professor Gilles Salles, Chair of the Clinical Hematology Department at the University of Lyon, France, and lead investigator of L-MIND.

L-MIND is designed to investigate the antibody tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are not eligible 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.

MorphoSys’s management will be available for a Q&A session on the headline data on Monday, May 20, 2019 at 2:00pm CEST (1:00pm BST/8:00am EDT).

MorphoSys plans to present detailed results at the ICML conference in Lugano in June this year.

Dial-in number for the Q&A session on Monday, May 20, 2019 at 2:00pm CEST; 1:00pm BST; 8:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
Participant PIN: 59149632#

About CD19 and tafasitamab (MOR208)
CD19 is broadly and homogeneously expressed across different B cell malignancies including DLBCL and CLL. CD19 has been reported to enhance B cell receptor (BCR) signaling, which is assumed important for B cell survival, making CD19 a potential target in B cell malignancies.
Tafasitamab (MOR208) is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. Fc-modification of tafasitamab is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. Tafasitamab has been observed in preclinical models to induce direct apoptosis by binding to CD19, which is assumed to be involved in B cell receptor (BCR) signaling.
MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population. The pivotal phase 2/3 B-MIND study is designed to investigate tafasitamab in combination with the chemotherapeutic agent bendamustine in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) in comparison to the combination of the anti-CD20 antibody rituximab plus bendamustine. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.