June 05, 2017 / 3:00 pm, CEST
Planegg/Munich, Germany, June 5, 2017
MorphoSys Presents Updated Clinical Data for Anti-CD38 Antibody MOR202 in Multiple Myeloma at ASCO 2017
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today presented updated safety and efficacy data from an ongoing phase 1/2a study of the anti-CD38 antibody MOR202 at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting in Chicago. 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). The trial is being conducted in heavily pre-treated patients with relapsed/refractory multiple myeloma.
"Antibodies directed against CD38 have been reported as a class of potential therapeutics for patients with relapsed or refractory multiple myeloma. Based on the maturing data generated for MOR202, we will intensify our evaluations to further develop this compound as a representative of this class," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "We are optimistic about the responses seen in patients treated with MOR202 plus LEN/DEX and POM/DEX as well as the relatively short infusion time and the occurrence of infusion-related reactions in a low proportion of patients observed. We look forward to results further maturing from patients treated in this ongoing trial and to presenting final data later this year."
MOR202 was given as a 2-hour infusion up to the highest dose of 16 mg/kg. Infusion-related reactions (IRRs) occurred in 6% of patients in the clinically relevant dose cohorts of MOR202 (4 mg/kg, 8 mg/kg, 16 mg/kg) and were limited to grade 1 or 2. The most frequent adverse events of grade 3 or higher were neutropenia, lymphopenia, and leukopenia in 42%, 40%, and 33% of patients respectively. No unexpected safety signals were observed.
Patients treated with MOR202 in combination with LEN/DEX had a median of three prior treatment regimens, 56% being refractory to at least one prior therapy. Median progression-free survival (PFS) was not yet reached, median follow-up was 7.5 months and 9 patients were still on study at data cut-off. 12 out of 17 patients (71%, based on the ITT population) reported an objective response (OR) to treatment, including one complete remission (CR), three very good partial responses (VGPR) and eight partial responses (PR).
Patients receiving MOR202 with POM/DEX, had a median of four prior treatment regimens, all being refractory to at least one prior therapy. Current median PFS is 17.5 months, with a median follow-up of 8.5 months. Eight patients were still on study at data cut-off. 6 out of 13 patients (46%, based on the ITT-population) showed an objective response, with two patients achieving a complete remission (CR).
Patients treated with MOR202 plus DEX had a median of five prior treatment regimens before study entry. Median PFS of this cohort was 4.7 months, with a median follow-up of 22.1 months. 5 out of 18 patients (28%, based on the ITT population) had an objective response.
Details of the MOR202 presentation at ASCO 2017
Abstract #8024, poster board #350
MOR202 with low-dose dexamethasone (DEX) and in combination with pomalidomide/DEX and lenalidomide/DEX in relapsed or refractory multiple myeloma (RRMM): Interim analysis of a phase 1/2a dose-escalation study
The poster will be presented during the "Hematologic Malignancies - Plasma Cell Dyscrasia" session on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall).
MorphoSys will hold an Investor & Analyst Event at the 2017 ASCO Annual Meeting on June 5, 2017, at 6:30pm CDT (June 6, 2017: 1:30am CEST). Clinical data for MorphoSys's investigational agents MOR208 and MOR202 will be presented by clinical investigators and company representatives.
A replay and the presentation will be made available at http://www.morphosys.com.
About MOR202 and the ongoing phase 1/2a study in multiple myeloma
The investigational drug MOR202 is a fully human HuCAL antibody directed against 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 with low dose dexamethasone and in combination with the immunomodulatory drugs (IMiDs) pomalidomide (POM) and lenalidomide (LEN) plus DEX in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 with DEX 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.
MorphoSys is committed to developing exceptional new treatments for patients suffering from serious diseases. A leader in the field of therapeutic antibodies today, MorphoSys is driven by the ambition of creating the most valuable pipeline of biopharmaceuticals in the biotechnology industry. Based on its proprietary technology platforms, MorphoSys, together with its partners, has built a therapeutic pipeline of more than 110 programs in R&D, around a quarter of which is currently in clinical development.
In its proprietary development segment, MorphoSys, alone or with partners, is developing new therapeutic candidates, mainly focusing on cancer and inflammation. In its partnered discovery segment, MorphoSys uses its technologies to discover new drug candidates for pharmaceutical partners and participates from the programs' further development success, through success-based payments and royalties. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
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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.
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