MOR202 WITH LOW-DOSE DEXAMETHASONE (DEX) OR POMALIDOMIDE/DEX OR LENALIDOMIDE/DEX IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM): A PHASE I/IIA, MULTICENTER, DOSE-ESCALATION STUDY
Author(s): ,
Marc Raab
Affiliations:
Department of Medicine V,University Hospital Heidelberg,Heidelberg,Germany
,
Manik Chatterjee
Affiliations:
Department of Internal Medicine II,University Hospital of Wuerzburg,Wuerzburg,Germany
,
Hartmut Goldschmidt
Affiliations:
Department of Medicine V,University Hospital Heidelberg and the National Center for Tumor Diseases,Heidelberg,Germany
,
Hermine Agis
Affiliations:
Department of Medicine I,University Hospital of Internal Medicine – AKH Wien,Vienna,Austria
,
Igor W. Blau
Affiliations:
Department of Internal Medicine III,Charité Campus Benjamin Franklin,Berlin,Germany
,
Hermann Einsele
Affiliations:
Department of Internal Medicine II,University Hospital of Wuerzburg,Wuerzburg,Germany
,
Monika Engelhardt
Affiliations:
Hematology & Oncology Department,Medical University Hospital,Freiburg,Germany
,
Barbara Ferstl
Affiliations:
Department of Internal Medicine 5 - Hematology and Oncology,Friedrich-Alexander-University Erlangen-Nuremberg,Erlangen,Germany
,
Martin Gramatzki
Affiliations:
Department of Medicine,University Hospital Schleswig-Holstein Division of Stem Cell Transplantation and Immunotherapy,Kiel,Germany
,
Christoph Röllig
Affiliations:
Department of Medicine I,University Hospital Carl Gustav Carus,Dresden,Germany
,
Katja Weisel
Affiliations:
Department of Hematology, Oncology, Immunology, Rheumatology and Pulmonology,University Hospital of Tuebingen,Tuebingen,Germany
,
Tiantom Jarutat
Affiliations:
Morphosys AG,Planegg,Germany
,
Dominika Weinelt
Affiliations:
Morphosys AG,Planegg,Germany
,
Mark Winderlich
Affiliations:
Morphosys AG,Planegg,Germany
,
Rainer Boxhammer
Affiliations:
Morphosys AG,Planegg,Germany
Christian Peschel
Affiliations:
Department of Internal Medicine III,Technical University of Munich,Munich,Germany
EHA Learning Center. Raab M. Jun 16, 2018; 214462
Marc Raab
Marc Raab

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Abstract
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Abstract: S848

Type: Oral Presentation

Presentation during EHA23: On Saturday, June 16, 2018 from 16:15 - 16:30

Location: Room A1

Background
CD38 is a type II transmembrane glycoprotein expressed by MM cells. MOR202, a human IgG1 CD38 monoclonal antibody, has shown high single-agent activity in preclinical models of MM and synergy in combination with immunomodulatory drugs (IMiDs®), lenalidomide (LEN) and pomalidomide (POM).

Aims

The primary objectives of the study were to evaluate the safety, maximum tolerated dose (MTD)/recommended phase II dose of MOR202 in patients with relapsed or refractory multiple myeloma.

Methods

This is an analysis of a multicenter, dose-escalation phase I/IIa study of MOR202 with data presentation from patient (pt) cohorts treated with clinically relevant doses of MOR202 (2-hour IV infusion; 4, 8 and 16 mg/kg q1w) + Dex (≤40 mg), or at 8 or 16 mg/kg q1w with an IMiD+Dex combination.

Results
As of September 2017, 91 pts had been treated, including 56 in clinically relevant cohorts: 18 received MOR202 + Dex, 17 MOR202 + LEN/Dex and 21 MOR202 + POM/Dex. Pts received a median of 3, 2 and 3 prior treatment lines, respectively. The MTD of MOR202 was not reached. Combinations were generally well tolerated, with grade ≥3 adverse events (AEs) of mainly hematological nature. 2 pts discontinued due to a MOR202-related AE (one patient with a grade 4 thrombocytopenia and one patient with a grade 3 bacterial infection complicated by acute kidney failure). Infusion-related reactions (all grade 1 or 2) were observed in 4/56 (7%) pts. These mainly occurred during the first infusion. In the MOR202 + Dex cohort, 5/18 (28%) pts showed a response: 3 partial responses (PRs) and 2 very good PRs (VGPRs). Responses were also observed in 11/17 (65%, 7 PRs, 3 VGPRs, 1 complete response [CR]) pts in the MOR202 + LEN/Dex cohort and 9/21 (43%, 3 PRs, 4 VGPRs and 2 CRs) in the MOR202 + POM/Dex cohort. Longest response duration was 25 months (MOR202/Dex). Preliminary results indicate preservation of high CD38 levels on MM cells under MOR202 therapy.

Conclusion

2-hour infusions of MOR202 administered at up to 16 mg/kg with Dex or in combination with an IMiD/Dex in heavily pretreated pts with RRMM showed a favorable safety profile, including excellent infusion tolerability. Promising preliminary efficacy and long-lasting tumor control were observed.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): CD38, Dose escalation, Multiple Myeloma

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