MorphoSys Presents Updated Clinical Data for Blood Cancer Candidate MOR208 in NHL and CLL at ASH 2016 Conference:
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MorphoSys Presents Updated Clinical Data for Blood Cancer Candidate MOR208 in
NHL and CLL at ASH 2016 Conference:
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MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced
today the presentation of updated safety and efficacy data from two ongoing
phase 2 clinical studies evaluating MOR208, an Fc-modified investigational
antibody targeting CD19, in patients with advanced B-cell malignancies, at the
58th American Society of Hematology (ASH) Annual Meeting in San Diego,
California/USA.
Continued long-lasting responses of more than 26 months reported in patients
with relapsed/refractory NHL in a phase 2a trial with MOR208 monotherapy
An oral presentation reported data from a phase 2a study evaluating single-agent
MOR208 in 92 patients with various subtypes of relapsed or refractory non-
Hodgkin's lymphoma (NHL) including diffuse large B-cell lymphoma (DLBCL),
follicular lymphoma (FL) and other indolent NHL (iNHL). Results were consistent
with prior updates from the study, reflecting in particular a continuation of
long-lasting responses of more than 26 months.
"Patients with NHL, who are refractory or show relapse after previous anti-CD20-
based therapies, have limited treatment alternatives and usually a very poor
prognosis. These updated results illustrate our ongoing efforts to develop
MOR208 as a potential new CD19-based antibody therapy for patients suffering
from B-cell malignancies, including DLBCL, in phase 2 studies in combination
with other cancer drugs," said Dr. Arndt Schottelius, Chief Development Officer
of MorphoSys AG.
At the last cutoff date, June 3, 2016, three patients with DLBCL and six with
iNHL were in remission and on study treatment, with the longest responses in
both subgroups ongoing for more than 26 months. Of these nine patients, seven
showed complete responses and 2 experienced partial responses. The median
duration of response was 20.1 months for DLBCL and not yet reached for iNHL. The
overall response rate (ORR), based on complete responses (CR) and partial
responses (PR), was 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. The progression free survival
(PFS) rate at 12 months was 39% in both subgroups. In addition to the patients
with an objective response (PR or CR), the majority of patients with stable
disease (SD) (5/6 DLBCL and 14/17 iNHL) had a reduction in target lesion size
(central assessment).
PFS was similar in patients with rituximab non-refractory versus rituximab
refractory tumors. Fifty-two patients (57%) in the study were classified as
having rituximab refractory disease. Of those, five of 24 patients (21%) with
DLBCL and five of 22 patients (23%) with iNHL responded to MOR208. Of the 10
responders with rituximab refractory disease, six had a response duration longer
than 10 months, two of which lasted for more than 26 months.
The most common adverse events were infusion-related reactions (IRRs) occurring
in 12% of the patients (11% of grade 1 or 2, 1% of grade 4) and neutropenia
occurring in 12% of patients (3% of grade 1 or 2, 9% of grade 3 or higher). No
treatment-related deaths were reported.
Number and title of the presentation
Abstract #623
Jurczak et al: Single-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin's
Lymphoma (NHL): Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent
NHL Subgroups of a Phase IIa Study
Combination of MOR208 with lenalidomide and ibrutinib in CLL from phase 2
investigator-initiated trial
A second presentation is a poster from investigators at The Ohio State
University, who reported on an investigator-initiated trial (IIT) evaluating
MOR208 in combination with lenalidomide in three cohorts of patients with
chronic lymphatic leukemia (CLL): previously untreated CLL patients,
relapsed/refractory CLL patients; and patients with Richter's Transformation.
The trial also included a 4th cohort of ibrutinib-treated CLL patients with
identified resistance mutations to ibrutinib in the tumors (molecular relapse)
but no confirmed clinical relapse where MOR208 was added to ibrutinib therapy.
Recent data have generally shown poor clinical outcomes in patients who relapse
after a therapy with the BTK inhibitor ibrutinib and whose leukemia cells carry
a mutation in the BTK gene prior to relapse.
According to the data presented, 34 patients have been enrolled in the study so
far, 27 receiving MOR208 in combination with lenalidomide (11 of which in the
previously untreated cohort, 11 in the relapsed/refractory cohort, 5 in the
Richter's Transformation cohort) and 7 receiving MOR208 plus ibrutinib, with
patient accrual still ongoing.
Most frequent hematological adverse event over all cohorts were thrombocytopenia
in 47% of patients (9% grade 3 or higher) and neutropenia in 35% (21% grade 3 or
higher). There were no unexpected serious adverse events reported.
According to the abstract, in the group of CLL patients with ibrutinib-resistant
cells receiving MOR208 in addition to ibrutinib, four out of seven patients have
been on study for at least 3 cycles of 28 days each already, and no patient had
developed progressive disease at the time of abstract data cut-off. Preliminary
activity has been seen in all cohorts, including ibrutinib-resistant CLL
patients.
"There is a high unmet medical need for CLL patients, especially those showing
resistance to ibrutinib therapy," said Dr. Jennifer Woyach, Assistant Professor
of Internal Medicine at Ohio State University. "Therefore we added an additional
cohort to our ongoing CLL study to evaluate MOR208 in combination with ibrutinib
in order to investigate whether MOR208 could be a promising combination partner
in this setting. We are looking forward to the continuation of the trial and to
present further results going forward."
Number and title of the presentation
Abstract #4386
Woyach et al: Updated Results from a Phase II Study of the Fc Engineered CD19
Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic
Lymphocytic Leukemia (CLL) and Richter's Transformation or Ibrutinib for
Patients with Ibrutinib-Resistant Clones
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 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/2061933/773452.pdf
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Source: MorphoSys AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.12.2016 - 07:30 Uhr
Sprache: Deutsch
News-ID 510992
Anzahl Zeichen: 10133
contact information:
Town:
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Kategorie:
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