MorphoSys Presents Updated Phase 2 Clinical Results for MOR208 Monotherapy in NHL at ASCO Annual Meeting
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MorphoSys Presents Updated Phase 2 Clinical Results for MOR208 Monotherapy in
NHL at ASCO Annual Meeting
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Matured Data Set Shows Six Complete Remissions with Durable Responses in Diffuse
Large B-cell Lymphoma and Follicular Lymphoma
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today
announced updated clinical data on its proprietary drug candidate MOR208. MOR208
is a potent anti-CD19 antibody with a proprietary modification to the Fc portion
that is being developed to treat B-cell malignancies. The data, which were
presented today at the 2015 American Society of Clinical Oncology (ASCO) Annual
Meeting, are from an ongoing phase 2a study of patients with four different
subtypes of relapsed or refractory Non-Hodgkin's Lymphoma (NHL). The clinical
data show that MOR208 is well tolerated with a low level of infusion reactions
and demonstrates encouraging single-agent activity. Based on these encouraging
results, MorphoSys plans to advance MOR208 into two combination trials in DLBCL.
"The results for MOR208 have matured significantly since we presented the
program at ASH 2014 with two additional complete remissions reported and first-
published results for the duration of response. It is worth noting that MOR208
was used as monotherapy in this trial, and the good tolerability we observed
supports our plans to test combinations with other drugs," commented Dr. Arndt
Schottelius, Chief Development Officer of MorphoSys AG. "The results we've seen
in the clinic justify our ambitious program for this exciting drug candidate,
which include two subsequent studies evaluating MOR208 in combination with
lenalidomide and bendamustine to treat DLBCL."
The preliminary data presented today at ASCO summarize efficacy and safety
results for 92 heavily pre-treated patients. The overall response rate was 28%
across all four subtypes of NHL and reached 36% in the DLBCL subgroup (both
based on evaluable patients). At the time of the analysis, the majority of
responders - 16 out of 21 - had an ongoing response to the treatment. The
longest response duration observed so far exceeded 14.2 months in DLBCL, 15.4
months in FL and 10.8 months in other iNHL.
The open-label, phase 2a, multicenter study was designed to assess the activity
and safety of single-agent MOR208 in patients with diffuse large B-cell lymphoma
(DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other
indolent NHL (iNHL), who had received at least one prior rituximab-containing
therapy. Patients were initially treated with a total of eight weekly doses of
12 mg/kg MOR208. Those with at least stable disease stayed on MOR208 treatment
for an additional four weeks. After completion of these twelve weekly doses of
treatment, responding patients, who demonstrated at least partial response
received maintenance therapy until disease progression or unacceptable toxicity.
Investigator assessed response in the NHL subtype specific cohorts
+----------------------------+------------------------------------+---------+
| | NHL subtypes (patients per cohort) | |
| +-------+------+------+--------------+---------+
| | DLBCL | FL | iNHL | MCL | Overall |
| Best overall response | (35) | (34) | (11) | (12) | (92) |
+----------------------------+-------+------+------+--------------+---------+
| Complete responses | 2 | 2 | 2 | 0 | 6 |
+----------------------------+-------+------+------+--------------+---------+
| Partial responses | 7 | 7 | 1 | 0 | 15 |
+----------------------------+-------+------+------+--------------+---------+
| Stable disease | 5 | 17 | 4 | 6 | 32 |
+----------------------------+-------+------+------+--------------+---------+
| Progressive disease | 11 | 4 | 3 | 5 | 23 |
+----------------------------+-------+------+------+--------------+---------+
| Not evaluable | 10 | 4 | 1 | 1 | 16 |
+----------------------------+-------+------+------+--------------+---------+
| ORR* per cohort | 26% | 26% | 27% | 0% | 23% |
+----------------------------+-------+------+------+--------------+---------+
| ORR (evaluable patients**) | 36% | 30% | 30% | 0% | 28% |
+----------------------------+-------+------+------+--------------+---------+
*Overall Response Rate (ORR) = Number of complete responses + partial responses
versus total
** Patients that have completed two cycles of treatment and subsequently
received disease response assessment
DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; iNHL, indolent
non-Hodgkin's lymphoma; MCL, mantle cell lymphoma; NHL, non-Hodgkin's lymphoma;
pts, patients
The ASCO presentation can be downloaded from the Company's website:
Phase 2a study of single-agent MOR208 in patients with relapsed or refractory B-
cell non-Hodgkin's lymphoma (NHL).
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 90 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®
and 100 billion high potentials® are registered trademarks of MorphoSys AG.
Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary
of MorphoSys AG.
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
Mario Brkulj
Associate Director Corporate Communications & IR
Alexandra Goller
Manager Corporate Communications & IR
Jessica Rush
Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
investors(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/1925255/690783.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
[HUG#1925255]
Unternehmensinformation / Kurzprofil:
Datum: 01.06.2015 - 16:56 Uhr
Sprache: Deutsch
News-ID 397284
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contact information:
Town:
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