×

MorphoSys Initiates Phase 2 Combination Trial of MOR208 and Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

MARTINSRIED / MUNICH, Germany, April 6, 2016 (GLOBE NEWSWIRE) -- MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that the first patient was dosed in a phase 2 combination trial of MOR208 with lenalidomide (Revlimid®). The trial, which has been named L-MIND (Lenalidomide-MOR208 IN DLBCL), is designed to evaluate the safety and efficacy of MOR208 in combination with the immunomodulatory drug lenalidomide in adult subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL), the most common form of non-Hodgkin's lymphoma (NHL). MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion, and is being developed to treat B cell malignancies.

The single-arm, open-label, multicenter L-MIND study is expected to enroll 80 patients in 56 centers in 9 European countries and the USA. At the time of study entry, patients must present with relapsed or refractory DLBCL, which had previously been treated with at least one and not more than two prior lines of therapy, including one anti-CD20 targeting therapy (e.g. rituximab). Patients must not be candidates for high-dose chemotherapy with autologous stem cell transplantation.

Patients will receive weekly intravenous infusions of 12mg/kg MOR208 for 12 weeks, followed by administration every second week for up to 2 years or until disease progression or unacceptable toxicity, whichever comes first. In addition to MOR208, lenalidomide will be administered orally, for up to one year.

The study's primary end point is overall response rate (ORR), comprising complete responses (CR) and partial responses (PR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS), as well as an evaluation of the drug combination's safety and pharmacokinetic parameters of MOR208.

"We are pleased to kick off the L-MIND trial as the first in a series of planned clinical studies evaluating combination therapies with MOR208 in hemato-oncological indications with high medical need. MOR208 has already demonstrated very encouraging single-agent activity and was well tolerated by patients in our phase 2a NHL trial as presented at the ASH 2015 conference in December 2015. In addition, an ongoing Phase 2 investigator-initiated trial has already shown good preliminary safety and activity of the combination of MOR208 and lenalidomide in patients suffering from chronic lymphocytic leukemia (CLL). These recent findings encourage us to explore the therapeutic potential of MOR208 in different combinations", said Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

Detailed information on the trial can be found at clinicaltrials.gov.

About MOR208:
MOR208 is an Fc-enhanced antibody targeting CD19, a more widely and earlier expressed target across multiple lymphomas and leukemias than CD20, the therapeutic target of the most commonly used lymphoma and leukemia targeted treatments. MOR208 has been engineered to possess significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), thus improving a key mechanism for tumor cell killing. By targeting CD19 and being Fc-enhanced, MOR208 could therefore become an important and attractive alternative to multiple current treatment options for some of the sickest cancer patients.
Updated interim data, presented at the 2015 annual meeting of the American Society of Hematology (ASH 2015) in December 2015, summarize efficacy and safety results for MOR208 monotherapy in 92 heavily pre-treated patients. The overall response rate was 28% across all four subtypes of non-Hodgkin's lymphoma (NHL) and reached 36% in the diffuse large B cell lymphoma (DLBCL) subgroup (both based on evaluable patients). At the time of the analysis, several responders - 9 out of 21 - had an ongoing response to the single-agent treatment. The longest response duration observed so far exceeded 20 months in both DLBCL and follicular lymphoma (FL).

About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 100 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group.

This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.

For more information, please contact:

MorphoSys AG
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR

Jochen Orlowski
Associate Director Corporate Communications & IR

Alexandra Goller
Senior Manager Corporate Communications & IR

Tel: +49 (0) 89 / 899 27-404
investors@morphosys.com

Media Release (PDF) http://hugin.info/130295/R/2000824/738138.pdf

HUG#2000824

Source: MorphoSys AG