DGAP-News: MorphoSys AG / Key word(s): Study results/Conference Planegg/Munich, Germany, December 11, 2017 MorphoSys Presents Clinical Data on MOR208 plus Lenalidomide in Aggressive Lymphoma (R/R DLBCL) at ASH 2017 Conference
- Preliminary median progression-free survival of 11.3 months - Objective response rate (ORR) of 52%, complete remission rate (CR) of 32% - No unexpected toxicities observed; no infusion-related reactions reported for MOR208 - MOR208 plus lenalidomide recently received FDA Breakthrough Therapy designation for non-transplant eligible patients with R/R DLBCL MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) today presented clinical data from the ongoing phase 2 clinical trial (L-MIND) evaluating MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). DLBCL is the most frequent type of malignant lymphoma worldwide and accounts for approximately 30% of all non-Hodgkin lymphomas. Data will be reported in a poster presentation (available for download) at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia/USA. MOR208 is an investigational Fc-engineered monoclonal antibody directed against CD19. The data presented at ASH formed the basis for the Breakthrough Therapy designation recently awarded by the FDA for MOR208, in combination with lenalidomide, for the treatment of non-transplant eligible patients with R/R DLBCL. At data cut-off (June 13, 2017), 51 patients had been enrolled in the study, of whom 44 were evaluable for efficacy assessments. Preliminary data show an objective response in 23 out of 44 patients (ORR: 52%), 19 (83%) of whom show ongoing responses. Complete remission was seen in 14 out of 44 patients (CR: 32%). The median time to response was 1.8 months, the median time to complete response was 2.3 months. The preliminary median progression-free survival (PFS) based on Kaplan Meier calculation was 11.3 months. No unexpected toxicities were observed for the treatment combination and no infusion-related reactions were reported for MOR208. The most frequent adverse events with a toxicity grading of 3 or higher were neutropenia, thrombocytopenia, and leukopenia, observed in 35%, 10%, and 8% of patients, respectively. Pneumonia and hypokalemia were reported for 10% and 8% of the patients. To date, 45% of patients required a reduction of their lenalidomide dose, from a starting dose of 25mg daily. The trial has recently completed patient recruitment as required by the study protocol. To date, 81 patients have been enrolled. "We are very encouraged by the updated clinical trial results from the ongoing L-MIND trial, especially the complete responses and the duration of responses we have seen so far. DLBCL is a very aggressive lymphoma. In particular, those patients with relapsed or refractory DLBCL who are not eligible for high-dose chemotherapy and autologous stem cell transplantation are in need of more therapeutic options. Based on the FDA Breakthrough Therapy designation we recently obtained, we intend to develop MOR208 together with lenalidomide as a potential new treatment option for this patient group as quickly as possible," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. The L-MIND trial (Lenalidomide plus MOR208 in DLBCL) is a single-arm, open-label, multicenter study of MOR208 in combination with lenalidomide. The trial is enrolling patients with relapsed or refractory DLBCL after up to three prior lines of therapy, with at least one prior therapy including an anti-CD20 targeting therapy (e.g. rituximab). Patients could not be candidates for high-dose chemotherapy and autologous stem cell transplantation. Patients enrolled had a median age of 74 years. Details of the MOR208 presentation at ASH 2017: Abstract #4123; Poster III The poster will be presented during the session #626 "Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)-Results from Prospective Clinical Trials" on Monday, December 11, 2017, 6:00pm-8:00pm EST (Dec. 12, 2017, 0:00am-2:00am CET), in the Georgia World Congress Center, Bldg A, Lvl 1, Hall A2. In addition to the presentation, the abstract has been published online in the December 8, 2017 supplemental volume of Blood. Additional information can be found at www.hematology.org, including the abstract. MorphoSys will hold an investor & analyst conference call after the 59th American Society of Hematology (ASH) Annual Meeting 2017 on December 12, 2017, 11:00am EST(5:00pm CET). Dial in: About CD19 and MOR208 About MorphoSys: HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R) and LanthioPep(R) 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 Jochen Orlowski Alexandra Goller Tel: +49 (0) 89 / 899 27-404 Additional features: Document: http://n.eqs.com/c/fncls.ssp?u=WTHNIBLCVE Document title: Media Release 11.12.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
Language: | English |
Company: | MorphoSys AG |
Semmelweisstr. 7 | |
82152 Planegg | |
Germany | |
Phone: | +49 (0)89 899 27-0 |
Fax: | +49 (0)89 899 27-222 |
E-mail: | investors@morphosys.com |
Internet: | www.morphosys.com |
ISIN: | DE0006632003 |
WKN: | 663200 |
Indices: | TecDAX |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange |
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