MorphoSys Presents Updated Clinical Data for MOR202 in Multiple Myeloma and for MOR208 in Non-Hodgkin's Lymphoma at ASCO 2016
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MorphoSys AG /
MorphoSys Presents Updated Clinical Data for MOR202 in Multiple Myeloma and for
MOR208 in Non-Hodgkin's Lymphoma at ASCO 2016
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MOR202 Combination Therapy with Complete Remissions in Multiple Myeloma
* MOR202 (8 mg/kg) plus Pom/Dex in relapsed/refractory multiple myeloma (MM)
patients shows two complete responses (CR) and two minor responses (MR) (one
of which is unconfirmed) out of five patients
* MOR202 (8 mg/kg) plus Len/Dex in MM shows two partial responses (PR) and one
very good partial response (VGPR) out of the four patients in this
combination cohort with a scheduled response assessment after one treatment
cycle
* First biomarker data suggest that CD38 expression on MM patient bone marrow
plasma cells was preserved during MOR202 therapy
* MOR202 administered in doses of up to 16 mg/kg as a 2-hour intravenous
infusion with low incidence of infusion-related reactions (IRR)
* MOR208 shows disease control rate (CR + PR + SD) of 40% in
relapsed/refractory diffuse large cell B cell lymphoma (DLBCL) and 73% in
indolent non-Hodgkin's lymphoma (iNHL) patients and duration of response (CR
or PR) of up to 26 months (responses ongoing)
* MOR208 leads to reduction in target lesion size also in patients with stable
disease (SD)
* MOR208 shows similar progression-free survival (PFS) in rituximab-refractory
and non-refractory patients
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today
presented updated safety and efficacy data from an ongoing clinical phase 1/2a
study evaluating the anti-CD38 antibody MOR202 alone and in combination with
immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom) plus
dexamethasone (Dex) in 63 heavily pre-treated patients with relapsed/refractory
multiple myeloma (MM). Data were reported during a poster presentation at the
2016 ASCO Annual Meeting. The updates compared to the last presentation of data
from this ongoing trial in December 2015 refer in particular to the combination
cohorts of MOR202 (8 mg/kg) plus IMiDs.
In the five-patient cohort receiving 8 mg/kg MOR202 in combination with Pom/Dex,
two patients reached a complete response (CR) and two patients a minor response
(MR) (one of which is unconfirmed). Among the four patients treated with 8 mg/kg
MOR202 in combination with Len/Dex and with a scheduled response assessment
after one treatment cycle, two reached a partial response (PR) and one a very
good partial response (VGPR).
MOR202 could be given in doses of up to 16 mg/kg as a 2-hour infusion to all
patients. Infusion-related reactions (IRRs) were observed in 14% of evaluated
patients (10% grade 1, 4% grade 2) and were mainly limited to the first
infusion.
Moreover, first biomarker data on CD38 expression on plasma cells derived from
bone marrow of all five MM patients with available second biopsies, suggested
that the CD38 target molecule was preserved during MOR202 therapy comparing
values at baseline and at cycle 2 day1.
"We are very pleased with the updated clinical results for MOR202 in multiple
myeloma, in particular with two complete responses out of five patients treated
with MOR202 plus Pom/Dex. Since we last reported data in December 2015, new and
deep responses have been reported with MOR202 in combination with IMiDs. On the
safety side, we were pleased to observe that MOR202 could be given to all
patients in a 2-hour infusion time, with infusion-related reactions of grade 1
and 2 in only 14% of patients," commented Dr. Arndt Schottelius, Chief
Development Officer of MorphoSys AG. "The dose escalation study will continue as
planned, focusing on the combination treatment, in particular the upcoming
cohorts of 16mg/kg MOR202 plus Pom/Dex and Len/Dex."
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.
MOR208: Updated results confirm responses. Subgroup analysis shows target lesion
shrinkage in patients with stable disease and activity of MOR208 independent of
the response to a prior rituximab treatment
In addition, MorphoSys today presented updated clinical data including a
subgroup analysis of a phase 2a study with the anti-CD19 antibody MOR208 in
relapsed/refractory patients with various subtypes of non-Hodgkin's lymphoma
(NHL) including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL),
mantle cell lymphoma (MCL), and other indolent NHL (iNHL). All patients had
received at least one prior rituximab-containing therapy.
According to the subgroup analysis data presented today, in addition to patients
achieving a partial or complete response (PR, CR), a clinical benefit was also
observed in other patients treated with MOR208. The majority of patients (5/6
DLBCL and 12/16 iNHL) with stable disease (SD) also had a reduction in the size
of the target lesions - despite the short treatment period of 3 cycles according
to protocol. This resulted in a disease control rate of 40% in DLBCL and 73% in
iNHL patients. Moreover, progression-free survival (PFS) with MOR208 therapy was
observed to be comparable in rituximab refractory and non-refractory NHL
patients (median PFS 5.3 versus 6.6 months, HR 0.85, 95% CI 0.45-1.6, p=0.59).
Thus, MOR208 has demonstrated in this trial activity independent of the response
to a prior anti-CD20 therapy. Updated data for the overall trial population
furthermore revealed that after 12 months the PFS rate was 40% in both DLBCL and
iNHL patients. Nine patients treated with MOR208 are still in remission (7 CRs,
2 PRs), the longest responses currently ongoing for 26 months.
"We are very happy with the updated clinical trial results with MOR208,"
commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "We
are impressed by the duration of responses of up to 26 months with MOR208 as a
single-agent in heavily pre-treated patients with relapsed/refractory NHL. We
were further pleased to observe a decline in the size of the tumor lesions in
many in the subgroup of patients with stable disease even when treated for a
short period of 3 cycles only. Overall, the updated clinical data presented at
ASCO strongly support our strategy to develop MOR208 in B cell malignancies, in
particular our planned combination trials in DLBCL and CLL."
MOR208 is an anti-CD19 antibody with a proprietary modification to the Fc
portion in clinical development to treat B cell malignancies. The open-label,
phase 2a, multicenter study was designed to assess the activity and safety of
weekly doses of 12 mg/kg MOR208 as a single agent in 92 pre-treated patients
with various subtypes of relapsed/refractory NHL patients. According to the data
observed, MOR208 showed a low level of infusion reactions. The overall response
rate (ORR) of MOR208 reached 36% in the DLBCL subgroup and 33% in iNHL patients
(both based on evaluable patients). Based on all patients with DLBCL and iNHL in
the study, the ORR was 26% and 29%, respectively.
In addition, the trial design of a phase 2 study of MOR208 (COSMOS trial) was
presented at the ASCO 2016 Annual Meeting. The trial is planned to evaluate
MOR208 in combination with idelalisib in chronic lymphocytic leukemia (CLL) and
small lymphocytic lymphoma (SLL), in patients no longer responding to or no
longer tolerating Bruton's tyrosine kinase (BTK) inhibitor therapy (e.g.
ibrutinib). After the discontinuation of several combination trials of
idelalisib with other compounds, this planned trial is currently under review
and discussions with regulatory authorities are ongoing. MorphoSys is currently
exploring alternative study designs to evaluate MOR208 in a combination trial in
CLL/SLL patients previously treated with a BTK inhibitor.
The posters presented at the Annual ASCO Meeting, June 6, 2016, 8:30 am CDT
(2:30 pm BST, 3:30 pm CEST), can be downloaded from the Company's website.
Abstract #8012
M. Raab et al: MOR202 alone and in combination with pomalidomide or lenalidomide
in relapsed or refractory multiple myeloma: Data from clinically relevant
cohorts from a phase 1/2a study.
Abstract #7545
W. Jurczak et al: Subgroup analyses of diffuse large B-cell lymphoma (DLBCL) and
indolent lymphoma cohorts from a phase 2a study of single-agent MOR208 in
patients with relapsed or refractory non-Hodgkin's lymphoma (R-R NHL).
Abstract #TPS7572
C.-M. Wendtner et al: A phase 2 study of MOR208 plus idelalisib in patients with
relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL) previously treated with a Bruton's tyrosine kinase inhibitor.
MorphoSys will hold on June 6, 2016 at 6:30 p.m. CDT (June 7, 2016 0:30 a.m.
BST, 1:30 a.m. CEST) an Investor & Analyst Event at the 2016 ASCO Annual
Meeting. KOLs will present the new clinical data for MOR208 and MOR202. A replay
and the presentation will be made available at http://www.morphosys.com. Live-
Webcast: http://morphosys.equisolvewebcast.com/investor-event-6-6-16
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
Alexandra Goller
Senior Manager Corporate Communications & IR
Jochen Orlowski
Associate Director Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
investors(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/2018258/749086.pdf
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: MorphoSys AG via GlobeNewswire
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