MorphoSys Presents Updated Clinical Results for Anti-CD38 Antibody MOR202 at ASH 2016
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MorphoSys AG /
MorphoSys Presents Updated Clinical Results for Anti-CD38 Antibody MOR202 at ASH
2016
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Updated Results Include Clinical Response Rates from Ongoing Phase 1/2a Study
with MOR202 in Patients with Relapsed / Refractory Multiple Myeloma
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 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). MOR202 is
an investigational human antibody targeting CD38. Data were presented during an
oral presentation at the 58th American Society of Hematology (ASH) Annual
Meeting in San Diego, California/USA.
"The results presented include updated data from higher dosing cohorts of MOR202
in combination with IMiDs, in patients being evaluable for efficacy and safety
assessment. In addition to the infusion time of 2 hours and the occurrence of
infusion-related reactions in only 7% of the patients, we are particularly
pleased with the responses seen in patients treated with MOR202 plus Len/Dex and
Pom/Dex", Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG,
commented. "We look forward to enrolling more patients in the highest dosing
cohorts of 16 mg/kg MOR202 in these combinations."
Patients treated with MOR202 in combination with Len/Dex had a median of 2 prior
regimens; 64% were refractory to their last therapy. In this arm of the trial,
91% of evaluable patients (10 out of 11) showed an objective response (defined
as either a complete response (CR) or a partial response (PR)) to MOR202 and
Len/Dex. Considering only patients in the highest dosing cohort of 16mg/kg
MOR202 plus Len, ORR (objective response rate) was 100%, with 7 out of 7
patients showing response to treatment.
In the group receiving MOR202 with Pom/Dex, patients had a median of 3 prior
therapies, all being refractory to their last therapy. In these heavily
pretreated patients, 57% (4 out of 7) showed a response, with two patients
achieving a complete remission (CR). In relapsed/refractory patients treated
with MOR202 alone, 29% (5 out of 17) showed an objective response.
Responses are ongoing in 16 of 19 patients, with the longest response ongoing
for more than 14 months. The median progression-free survival (PFS) of the
patients treated with MOR202 alone was 4.7 months; the median PFS for the
combination regimen has not yet been reached.
MOR202 was given as a 2-hour infusion up to the highest dose of 16 mg/kg.
Infusion-related reactions (IRRs) occurred in 7% of patients and were limited to
grade 1 or 2. The most frequent adverse events of grade 3 or higher were
lymphopenia, neutropenia and leukopenia. No unexpected safety signals were
observed. No treatment-related deaths were reported.
According to a biomarker analysis, CD38 molecules were preserved on bone marrow
plasma cells during MOR202 treatment, comparing values at baseline and at cycle
2 day 1.
Number und tittle of the presentation:
Abstract #1152
Raab et al: A Phase I/IIa Study of the CD38 Antibody MOR202 Alone and in
Combination with Pomalidomide or Lenalidomide in Patients with Relapsed or
Refractory Multiple Myeloma
MorphoSys held an Investor & Analyst Event at the 2016 ASH Annual Meeting on
December 5, 2016, at 8:00pm PST (December 6, 2016: 4:00am GMT, 5:00am CET). Two
clinical investigators presented clinical data for MorphoSys's investigational
agents MOR208 and MOR202.
A replay and the presentation will be made available at
http://www.morphosys.com.
Webcast: https://www.webcaster4.com/Webcast/Page/359/18722
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
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(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/2061922/773445.pdf
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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: 06.12.2016 - 07:30 Uhr
Sprache: Deutsch
News-ID 510993
Anzahl Zeichen: 7888
contact information:
Town:
Martinsried / Munich
Kategorie:
Business News
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