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PRESS RELEASE: MorphoSys' tafasitamab B-MIND DLBCL study successfully passed futility analysis

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DGAP-News: MorphoSys AG / Key word(s): Study results
MorphoSys' tafasitamab B-MIND DLBCL study successfully passed futility
analysis (news with additional features)
2019-11-18 / 16:33
The issuer is solely responsible for the content of this announcement.

Planegg/Munich, Germany, November 18, 2019

*MorphoSys' tafasitamab B-MIND DLBCL study successfully *
*passed futility analysis*

_IDMC recommends to increase patient number from currently 330 to 450._

MorphoSys (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR)
today announced that the ongoing tafasitamab phase 3 B-MIND study has
successfully passed the pre-planned, event-driven interim analysis for
futility. An independent data monitoring committee (IDMC) reviewed the data
and recommended to increase the number of patients from currently 330 to
450. B-MIND compares the efficacy of the CD19 antibody tafasitamab plus
bendamustine with rituximab plus bendamustine in patients with relapsed or
refractory diffuse large B cell lymphoma (r/r DLBCL).

Within the interim analysis for futility, data were assessed by the IDMC for
the probability of a positive study at primary completion. The IDMC assessed
efficacy data in both the overall patient population as well as in the
biomarker-positive subpopulation. The biomarker, described as patients with
a low natural killer cell count at baseline, was implemented as a co-primary
endpoint in an amendment of B-MIND in the first quarter 2019. The
recommendation to enroll more patients aims to increase statistical power of
the study in the biomarker-described patient subpopulation as well as the
overall patient population. Data of the analysis were not shared with
MorphoSys.

As a continuation of the B-MIND study protocol, enrollment will proceed
according to the original inclusion and exclusion criteria to allow for
ongoing comparison of the efficacy in the overall and biomarker positive
patient population. Top line results are expected to be available in Q1
2022.

"We are very pleased with the IDMC recommendation and see it as an important
step in the clinical development of tafasitamab", said Dr. Malte Peters,
Chief Development Officer of MorphoSys. "DLBCL is a difficult to treat
disease and has a high unmet medical need, so new treatment options are
highly needed. Independent of B-MIND, we are on track to complete our BLA
submission to the U.S. FDA for tafasitamab in combination with lenalidomide
by the end of 2019 based on the previously reported encouraging results from
the L-MIND and Re-MIND clinical studies."

About B-MIND
The pivotal phase 2/3 B-MIND study is designed to investigate tafasitamab in
combination with the chemotherapeutic agent bendamustine in patients with
relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy
(HDC) and autologous stem cell transplantation (ASCT) in comparison to the
combination of the anti-CD20 antibody rituximab plus bendamustine. Low
baseline peripheral blood natural killer cell count was implemented as a
biomarker in agreement with the FDA in the first quarter of 2019. A
pre-planned, event-driven interim analysis for futility of B-MIND took place
in November 2019 and led to an increase of the sample size of the study to
450 (increase from 330).

About CD19 and tafasitamab
CD19 is broadly and homogeneously expressed across different B cell
malignancies including DLBCL and CLL. CD19 has been reported to enhance B
cell receptor (BCR) signaling, which is assumed important for B cell
survival, making CD19 a potential target in B cell malignancies.
Tafasitamab is an investigational humanized Fc-engineered monoclonal
antibody directed against CD19. Fc-modification of tafasitamab is intended
to lead to a significant potentiation of antibody-dependent cell-mediated
cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP),
thus aiming to improve a key mechanism of tumor cell killing. Tafasitamab
has been observed in preclinical models to induce direct apoptosis by
binding to CD19, which is assumed to be involved in B cell receptor (BCR)
signaling.
Next to B-MIND, MorphoSys is clinically investigating tafasitamab as a
therapeutic option in B cell malignancies in a number of ongoing combination
trials. An open-label phase 2 combination trial (L-MIND study) is
investigating the safety and efficacy of tafasitamab in combination with
lenalidomide in patients with relapsed/refractory DLBCL who are not eligible
for high-dose chemotherapy (HDC) and autologous stem cell transplantation
(ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA
granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide
in this patient population. Re-MIND, the real-world data lenalidomide alone
matched control cohort met its primary endpoint in October 2019,
demonstrating clinical superiority of the tafasitamab/lenalidomide
combination compared to lenalidomide alone. In addition, tafasitamab is
currently being investigated in patients with relapsed/refractory CLL/SLL
after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor
therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

About MorphoSys
MorphoSys (FSE & NASDAQ: MOR) is a clinical-stage biopharmaceutical company
dedicated to the discovery, development and commercialization of
exceptional, innovative therapies for patients suffering from serious
diseases. The focus is on cancer. Based on its leading expertise in
antibody, protein and peptide technologies, 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. In
2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis,
became the first drug based on MorphoSys's antibody technology to receive
regulatory approval. The Company's most advanced proprietary product
candidate, tafasitamab (MOR208), has been granted U.S. FDA breakthrough
therapy designation for the treatment of patients with relapsed/refractory
diffuse large B-cell lymphoma (DLBCL). Headquartered near Munich, Germany,
the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US
Inc., has approximately 405 employees. More information at
https://www.morphosys.com [1].

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), LanthioPep(R) and ENFORCERTM are 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 expectations regarding the
outcome of the B-MIND interim analysis and the clinical development of
tafasitamab in combination with bendamustine versus rituximab and
bendamustine in the B-MIND study in r/r DLBCL,, the clinical development of
tafasitamab in combination with lenalidomide in the L-MIND study in r/r
DLBCL, the Re-MIND study, the further clinical development of tafasitamab as
well as interactions with regulatory authorities and expectations regarding
regulatory filings and possible approvals for tafasitamab. 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 MorphoSys' expectations regarding the outcome of the B-MIND
interim analysis and the clinical development of tafasitamab in combination
with bendamustine versus rituximab and bendamustine in the B-MIND study in
r/r DLBCL,, the clinical development of tafasitamab in combination with
lenalidomide in the L-MIND study in r/r DLBCL, the Re-MIND study, the
further clinical development of tafasitamab as well as interactions with
regulatory authorities and expectations regarding regulatory filings and
possible approvals for tafasitamab, MorphoSys' reliance on collaborations
with third parties, estimating the commercial potential of its development
programs and other risks indicated in the risk factors included in
MorphoSys's Annual Report on Form 20-F 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*

Dr. Sarah Fakih
Head of Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-26663
Sarah.Fakih@morphosys.com
Dr. Julia Neugebauer
Director Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-179
Julia.Neugebauer@morphosys.com
Dr. Verena Kupas
Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-26814
Verena.Kupas@morphosys.com

Additional features:

Document: http://n.eqs.com/c/fncls.ssp?u=HHWPCQKRRF [2]

(MORE TO FOLLOW) Dow Jones Newswires

November 18, 2019 10:33 ET ( 15:33 GMT)
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