15.06.2018
MorphoSys AG DE0006632003
DGAP-News: MorphoSys Presents Updated Clinical Data for Anti-CD38 Antibody MOR202 in Multiple Myeloma at EHA 2018
DGAP-News: MorphoSys AG / Key word(s): Study
MorphoSys Presents Updated Clinical Data for Anti-CD38 Antibody MOR202 in
Multiple Myeloma at EHA 2018 (news with additional features)
15.06.2018 / 08:30
The issuer is solely responsible for the content of this announcement.
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Planegg/Munich, Germany, June 15, 2018
MorphoSys Presents Updated Clinical Data for Anti-CD38 Antibody MOR202 in
Multiple Myeloma at EHA 2018
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; Nasdaq: MOR) today
presented updated data from the ongoing phase 1/2a study of the anti-CD38
antibody MOR202 in relapsed/refractory multiple myeloma at the European
Hematology Association (EHA) Annual Meeting 2018 in Stockholm. The dose
escalation trial comprises three arms: MOR202, MOR202 in combination with
the immunomodulatory drug (IMiD) lenalidomide (LEN), and MOR202 in
combination with the IMiD pomalidomide (POM), in each case with low-dose
dexamethasone (DEX).
"We are optimistic about the responses seen in patients with multiple
myeloma treated with MOR202 plus LEN/DEX and POM/DEX based on matured data
as well as about the low proportion of patients experiencing
infusion-related reactions," commented Dr. Malte Peters, Chief Development
Officer of MorphoSys AG. "There is a medical need for new treatment options
in multiple myeloma and we look forward to further maturing data from this
ongoing trial."
In total, 56 patients were evaluable for safety and efficacy analysis in the
clinically relevant dose cohorts of MOR202 (4 mg/kg, 8 mg/kg, 16 mg/kg) by
the time of the data cut-off at December 31, 2017. At data cut-off, 16
patients remained in the study. Of the 56 evaluable patients, 18 had
received MOR202 plus DEX, 21 received the combination of MOR202 and POM/DEX
and 17 received MOR202 plus LEN/DEX.
MOR202 was given as a two-hour infusion up to the highest dose of 16 mg/kg.
Infusion-related reactions (IRRs) occurred in 11% of patients in the
clinically relevant dose cohorts of MOR202 and were limited to grade 1 or 2.
Further, infusion time could be shortened to 30 minutes in the majority of
the 16 patients remaining on study as per the data cut-off date.
The most frequent adverse events of grade 3 or higher were neutropenia,
lymphopenia, and leukopenia in 52%, 48%, and 39% of patients, respectively.
No unexpected safety signals were observed.
Patients treated with MOR202 in combination with LEN/DEX had a median of two
prior treatment lines, 59% being refractory to at least one prior therapy.
Median progression-free survival (PFS) was not yet reached. With six of the
17 patients in this cohort still on study at data cut-off, the median
follow-up was 16.6 months. An objective response was observed in eleven out
of 17 patients (65%), with two complete responses (CR), three very good
partial responses (VGPR) and seven partial responses (PR).
Patients receiving MOR202 with POM/DEX, had a median of three prior
treatment lines, all being refractory to the last prior therapy. Median PFS
was 17.5 months. With ten out of 21 patients in this cohort still on study
at data cut-off, the median follow-up was 6.5 months. An objective response
was observed in ten out of 21 patients (48%), with two patients achieving a
complete response (CR), four patients with a very good partial response
(VGPR) and four partial responses (PR).
Patients treated with MOR202 plus DEX had a median of three prior treatment
regimens, with 67% being refractory to any prior therapy. Median PFS in this
cohort was 8.4 months. All patients had discontinued the study before data
cut-off, i.e., follow-up for this cohort is completed. An objective response
was observed in five out of 18 patients (28%).
Details of the MOR202 presentation at EHA 2018
Abstract Code: S848
MOR202 with low-dose dexamethasone (DEX) or pomalidomide/DEX or
lenalidomide/DEX in relapsed or refractory multiple myeloma (r/r MM): A
phase I/IIa, multicenter, dose-escalation study
The oral presentation will be given during the session "New therapeutic
strategies to improve the outcome of relapse/refractory plasma cell
disorders" on Saturday, June 16, 2018, from 4:15-4:30pm CEST (10:15-10:30am
EDT), in Room A1 at the Stockholmsmässan in Stockholm.
Additional information can be found at www.ehaweb.org, including the
abstracts.
About MorphoSys
MorphoSys is a late-stage, biopharmaceutical company devoted to the
development of innovative and differentiated therapies for patients
suffering from serious diseases. Based on its technological leadership in
generating antibodies, MorphoSys, together with its partners, has developed
and contributed to the development of more than 100 product candidates, of
which 28 are currently in clinical development. This broad pipeline spans
MorphoSys's two business segments: Proprietary Development, in which
MorphoSys invests in product candidates for its own account, and Partnered
Discovery, in which product candidates are developed exclusively for a
variety of Pharma and Biotech partners. In 2017, Tremfya(R) (guselkumab),
marketed by Janssen, became the first therapeutic antibody based on
MorphoSys's proprietary technology to receive marketing approval for the
treatment of moderate-to-severe plaque psoriasis in the United States, the
European Union and Canada. MorphoSys is listed on the Frankfurt Stock
Exchange and on the U.S. stock exchange Nasdaq, 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.
Tremfya(R)
is a trademark of Janssen Biotech, Inc.
MorphoSys forward looking statements
This communication contains certain forward-looking statements concerning
the MorphoSys group of companies, including the progression of and upcoming
data presentations in connection with MOR202 and pomalidomide and
lenalidomide each combined with dexamethasone and the development in the
phase 1/2a clinical trial in multiple myeloma. The forward-looking
statements contained herein represent the judgment of MorphoSys as of the
date of this release and involve known and unknown risks and uncertainties,
which might cause the actual results, financial condition and liquidity,
performance or achievements of MorphoSys, or industry results, to be
materially different from any historic or future results, financial
conditions and liquidity, performance or achievements expressed or implied
by such forward-looking statements. In addition, even if MorphoSys' results,
performance, financial condition and liquidity, and the development of the
industry in which it operates are consistent with such forward-looking
statements, they may not be predictive of results or developments in future
periods. Among the factors that may result in differences are the inherent
uncertainties associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements,
MorphoSys' reliance on collaborations with third parties and other risks
indicated in the risk factors included in MorphoSys's Registration Statement
on Form F-1 and other filings with the US Securities and Exchange
Commission. Given these uncertainties, the reader is advised not to place
any undue reliance on such forward-looking statements. These forward-looking
statements speak only as of the date of publication of this document.
MorphoSys expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change in its
expectations with regard thereto or any change in events, conditions or
circumstances on which any such statement is based or that may affect the
likelihood that actual results will differ from those set forth in the
forward-looking statements, unless specifically required by law or
regulation.
For more information, please contact:
MorphoSys AG
Alexandra Goller
Associate Director Corporate Communications & IR
Jochen Orlowski
Associate Director Corporate Communications & IR
Dr. Claudia Gutjahr-Löser
Investor Relations Officer
Tel: +49 (0) 89 / 899 27-404
[email protected]
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Additional features:
Document: http://n.eqs.com/c/fncls.ssp?u=XITIDDJPHX
Document title: Press release
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15.06.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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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: [email protected]
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
End of News DGAP News Service
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