PLANEGG/MUNICH, GERMANY / ACCESSWIRE / June 5, 2017 / MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC PINK: MPSYY)
today presented safety and efficacy data from an ongoing phase 2 clinical trial ("L-MIND" study) evaluating MOR208 in combination
with lenalidomide in patients with relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL). DLBCL is the most common
form of non-Hodgkin's lymphoma. Data were reported during a poster presentation at the 2017 Annual Meeting of the American Society
of Clinical Oncology (ASCO) in Chicago/USA. MOR208 is an Fc-enhanced investigational antibody directed against CD19.
"We are very excited having seen the preliminary data from the first 44 patients of our ongoing phase 2 L-MIND trial. We are
particularly optimistic about the level of response rates that we have seen so far, especially complete responses. For DLBCL
patients who relapse after their first-line treatment, current treatment options are very limited. We are therefore exploring
potential new treatment regimens with MOR208 for this difficult-to-treat patient group," commented Dr. Malte Peters, Chief
Development Officer of MorphoSys AG.
44 patients were enrolled in the study at data cut-off, 34 of whom were evaluable for efficacy assessment. Preliminary data show
an objective response in 19 out of 34 patients (ORR: 56%). Complete remission was seen in 11 out of 34 patients (CR: 32%). 16 out
of 19 patients in whom responses were recorded, were still on study at time of data-cut off.
No infusion-related reactions were reported for MOR208. The most frequent adverse events observed of grade 3 or higher were
hematological, comprising neutropenia, thrombocytopenia, and leukopenia, seen in 32%, 9%, and 9% of patients, respectively. To
date, 27% of patients required a reduction of the lenalidomide dose due to side effects. No unexpected safety-related effects were
observed.
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 will enroll approximately 80 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 in the trial could
not be candidates for high-dose chemotherapy or autologous stem cell transplantation. Patients enrolled in the trial had a median
age of 73 years.
In addition to the preliminary data from the phase 2 L-MIND study with MOR208 and lenalidomide in R/R DLBCL, two
"trial-in-progress" posters about MOR208 were presented at ASCO 2017 illustrating the study designs of two other ongoing clinical
combination trials of MOR208: the phase 2/3 randomized, "B-MIND" study comparing MOR208 plus bendamustine vs. rituximab plus
bendamustine in patients with R/R DLBCL; and the phase 2 "COSMOS" study in R/R chronic lymphocytic leukemia (CLL) patients, who had
previously discontinued treatment with a Bruton tyrosine kinase (BTK) inhibitor. The COSMOS trial is currently investigating MOR208
in combination with idelalisib.
Details of the MOR208 presentations at ASCO 2017
Abstract #7514, poster board #276
L-MIND: MOR208 combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R-R
DLBCL) - A single-arm phase 2 study.
The poster will be presented during the session, "Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia," held on
June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall). The results will also be highlighted during a poster discussion session about
CD19 targeting therapies on June 5, 2017 (1:15 PM-2:30 PM CDT, room E354b).
Abstract #TPS7571, poster board #330b
B-MIND: MOR208 plus bendamustine (BEN) versus rituximab (RTX) plus BEN in patients with relapsed or refractory (R-R) diffuse
large B-cell lymphoma (DLBCL): An open-label, randomized phase 2/3 trial.
The poster will be presented in the "Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia" session on June 5,
2017 (8:00 AM-11:30 AM CDT, poster hall).
Abstract #TPS7567, poster board#328b
COSMOS: MOR208 plus idelalisib or venetoclax in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL) previously treated with a Bruton's tyrosine kinase inhibitor (BTKi) - A two-cohort phase 2
study.
The poster will be presented in the "Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia" session on June 5,
2017 (8:00 AM-11:30 AM CDT, poster hall).
MorphoSys will hold an Investor & Analyst Event at the 2017 ASCO Annual Meeting on June 5, 2017, at 6:30pm CDT (June 6, 2017:
1:30am CEST). Clinical data for MorphoSys's investigational agents MOR208 and MOR202 will be presented by clinical investigators
and company representatives.
A replay and the presentation will be made available at http://www.morphosys.com.
Live-Webcast: https://services.choruscall.com/dataconf/productusers/morph/mediaframe/19794/indexl.html
About CD19 and 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.
MOR208 (previously Xmab(R)5574) is an Fc-enhanced monoclonal antibody directed against CD19. Fc-modification of MOR208 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. Furthermore, MOR208 has been observed
in preclinical models to induce direct apoptosis by binding to CD19, which is assumed to be a crucial component for B cell receptor
(BCR) signaling.
MorphoSys AG is clinically investigating MOR208 as a therapeutic option in B cell malignancies in a number of ongoing
combination trials. A phase 2 combination trial (L-MIND study) was started in March 2016 and is designed to investigate the safety
and efficacy of MOR208 in combination with lenalidomide in approximately 80 patients with relapsed/refractory DLBCL. The phase 2/3
B-MIND study was started in August 2016 and transitioned into its phase 3 pivotal part in June 2017 following a recommendation of
the IDMC based on the available data from the phase 2 initial safety evaluation. The B-MIND study is designed to investigate MOR208
in combination with the chemotherapeutic agent bendamustine in relapsed/refractory DLBCL patients 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. Furthermore, in December 2016, a third phase 2 combination trial was started with MOR208
evaluating the antibody in patients with relapsed/refractory CLL after discontinuation of a prior Bruton tyrosine kinase (BTK)
inhibitor therapy (e.g. ibrutinib). Currently MOR208 is being studied in combination with idelalisib; a second study arm of MOR208
plus venetoclax is currently in preparation.
About MorphoSys
MorphoSys is committed to developing exceptional new treatments for patients suffering from serious diseases. A leader in the
field of therapeutic antibodies today, MorphoSys is driven by the ambition of creating the most valuable pipeline of
biopharmaceuticals in the biotechnology industry. Based on its proprietary technology platforms, MorphoSys, together with its
partners, has built a therapeutic pipeline of more than 110 programs in R&D, around a quarter of which is currently in clinical
development.
In its proprietary development segment, MorphoSys, alone or with partners, is developing new therapeutic candidates, mainly
focusing on cancer and inflammation. In its partnered discovery segment, MorphoSys uses its technologies to discover new drug
candidates for pharmaceutical partners and participates from the programs' further development success, through success-based
payments and royalties. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about
MorphoSys, visit http://www.morphosys.com.
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
Anke Linnartz 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
SOURCE: MorphoSys AG via the EQS Newswire distribution service including
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