MorphoSys Presents Updated Clinical Results for MOR202 at Medical Conference
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MorphoSys Presents Updated Clinical Results for MOR202 at Medical Conference
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In Ongoing Phase 1/2a Study, Anti-CD38 Antibody Continues to Show Encouraging
Clinical Response Rates in Heavily Pre-Treated Multiple Myeloma Patients
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) presented
updated safety and efficacy data from an ongoing phase 1/2a clinical study
evaluating MOR202, an investigational antibody targeting CD38, alone and in
combination with immunomodulatory drugs (IMiDs) lenalidomide (Len) and
pomalidomide (Pom), plus dexamethasone (Dex) in heavily pre-treated patients
with relapsed/refractory multiple myeloma (MM). Data were presented during a
poster presentation at the 2016 annual meeting of the German, Austrian and Swiss
Societies for Hematology and Medical Oncology in Leipzig/Germany.
Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG, commented: "We
are very pleased that these results are consistent with earlier data from the
ongoing trial and show further improved responses with more patients being
evaluable for efficacy and safety assessment. In addition to the very short
infusion-time, we are particularly interested in the efficacy results in
patients treated with MOR202 plus pomalidomide, who had a median of four prior
therapies. The dose escalation study is ongoing as planned, currently focusing
on the highest dose cohorts of 16 mg/kg MOR202 in combination with pomalidomide
and lenalidomide."
78 % of evaluable patients (7 out of 9) treated with MOR202 in combination with
Len/Dex showed an objective response (i.e. complete response (CR) or partial
response (PR)). In the patient group treated with MOR202 plus Pom, 60 % (3 out
of 5) showed an objective response, with two patients achieving a complete
remission (CR). Considering only patients enrolled per protocol, the ORR
(objective response rate) in this patient group rises to 75 % and the CR rate to
50 %. Of the patients treated with MOR202 alone, so far 29 % (5 out of 17)
showed an objective response. Median time to response was six weeks with most
responses deepening over time. 12 of the 15 responses are currently ongoing for
up to 56 weeks.
When MOR202 was given as a 2-hour infusion up to the highest dose of 16 mg/kg,
92 % of patients treated showed no infusion-related reactions (IRRs). IRRs
occurred in just 8 % of patients (3 % of grade 1, 5 % of grade 2) and were
mainly limited to the first infusion. No unexpected safety signals were
observed. The most frequent adverse events of grade 3 or higher were, as
expected, hematological and included lymphopenia, neutropenia and leukopenia. No
treatment-related deaths were reported.
Biomarker data on bone marrow plasma cells suggests that during MOR202 therapy,
expression of CD38 as the target molecule for MOR202 seems to be preserved.
The poster presented at the DGHO Annual Meeting can be downloaded from the
Company's website.
About MOR202 and the ongoing phase 1/2a study in multiple myeloma
The investigational drug MOR202 is a fully human HuCAL antibody targeting CD38,
a highly expressed and validated target in multiple myeloma. Data are from an
ongoing clinical phase 1/2a, open-label, multi-center, dose-escalation study
conducted in several sites in Germany and Austria. The study is evaluating the
safety and preliminary efficacy of MOR202 alone and in combination with the
immunomodulatory drugs pomalidomide (Pom) and lenalidomide (Len) plus
dexamethasone (Dex) in patients with relapsed/refractory multiple myeloma. The
primary endpoints of the trial are the safety, tolerability and recommended dose
of MOR202 alone and in combination with the IMiDs. Secondary outcome measures
are pharmacokinetics and preliminary efficacy based on overall response rate,
duration of response, time-to-progression, and progression-free survival.
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(at)morphosys.com
Media release (PDF):
http://hugin.info/130295/R/2048492/766279.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: MorphoSys AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 17.10.2016 - 07:31 Uhr
Sprache: Deutsch
News-ID 500707
Anzahl Zeichen: 6983
contact information:
Town:
Martinsried / Munich
Kategorie:
Business News
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