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L-MIND: MOR208 COMBINED WITH LENALIDOMIDE (LEN) IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (R-R DLBCL) - A SINGLE-ARM PHASE II STUDY
Author(s): ,
Kami Maddocks
Affiliations:
Department of Internal Medicine, Division of Hematology,The Ohio State University Comprehensive Cancer Center,Columbus, OH,United States
,
Eva González Barca
Affiliations:
Department of Hematology, Institut Catalá d'Oncología,Hospital Duran i Reynals, IDIBELL,Barcelona,Spain
,
Wojciech Jurczak
Affiliations:
Department of Hematology,Jagiellonian University,Kraków,Poland
,
Anna Marina Liberati
Affiliations:
SC Oncoematologia,Azienda Ospedaliera Santa Maria,Terni,Italy
,
Johannes Duell
Affiliations:
Medizinische Klinik und Poliklinik II,University Hospital of Würzburg,Würzburg,Germany
,
Zsolt Nagy
Affiliations:
First Department of Internal Medicine,Semmelweis University,Budapest,Hungary
,
Tomáš Papajík
Affiliations:
Department of Hemato-Oncology,Palacký University Olomouc and the University Hospital Olomouc,Olomouc,Czech Republic
,
Marc Andre
Affiliations:
Université catholique de Louvain,CHU UCL Namur, Department of Hematology,Yvoir,Belgium
,
Nagesh Kalakonda
Affiliations:
Department of Haematology,Royal Liverpool University Hospital,Liverpool,United Kingdom
,
Martin Dreyling
Affiliations:
University Hospital of LMU,Munich,Germany
,
Pier Luigi Zinzani
Affiliations:
Institute of Hematology “L. e A. Seràgnoli”,University of Bologna,Bologna,Italy
,
Sumeet Ambarkhane
Affiliations:
MorphoSys AG,Planegg,Germany
,
Johannes Weirather
Affiliations:
MorphoSys AG,Planegg,Germany
Gilles Salles
Affiliations:
Hospices Civils de Lyon,Centre Hospitalier Lyon Sud, Service d'Hématologie,Pierre Bénite,France
(Abstract release date: 05/18/17) EHA Library. Kami J. M. 06/24/17; 181757; S470
Dr. Maddocks Kami J.
Dr. Maddocks Kami J.
Contributions
Abstract

Abstract: S470

Type: Oral Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 17:00 - 17:15

Location: Hall C

Background
The Fc-enhanced CD19 antibody MOR208 and the immunomodulatory drug LEN have demonstrated single agent activity in patients with R-R DLBCL. MOR208 and LEN have shown synergy in vitro and in vivo in preclinical lymphoma models.

Aims
This ongoing phase II study was designed to assess the safety and efficacy of MOR208 plus LEN in patients with R-R DLBCL.

Methods
Patients >18 years of age with R-R DLBCL, ECOG performance status 0–2, adequate organ function, having previously received at least 1 but not more than 3 prior therapies, including at least 1 CD20-targeting regimen and who are not candidates for autologous stem cell transplant (ASCT), are eligible. Treatment comprises up to 12, 28-day cycles of MOR208 12 mg/kg IV, administered weekly during cycles 1–3 (loading dose day 4 of cycle 1) and every second week during cycles 4–12 plus LEN 25 mg administered po days 1–21 of each cycle. Patients progression-free after 12 cycles receive up to 12 additional cycles of MOR208 12 mg/kg IV, administered every second week. The primary endpoint is the overall response rate (ORR) by central radiology assessment. Secondary endpoints include disease control, duration of response, progression-free and overall survival, safety, and response by cell of origin and other biomarkers. A preplanned safety evaluation was undertaken.

Results
31 of 80 planned patients were enrolled prior to data cutoff (3 January 2017). Median age was 74 years (range 47–82); 45% of patients received ≥2 prior lines of therapy; 23% had rituximab refractory disease; 74% had Ann Arbor stage ≥III disease; 65% had elevated lactate dehydrogenase level, and 52% had a poor revised International Prognostic Index (3–5). The most common treatment-emergent adverse events (any grade/grade ≥3 [% patients]) were neutropenia (39/26), anemia (23/0) thrombocytopenia (16/6), infections (26/10) diarrhea (13/0), pyrexia (13/0), and rashes (13/6). Of 26 response evaluable patients (median follow-up 3.3 months), ORR (investigator assessed) was 58% (15 patients), with 7 (27%) complete responses. Median time to response was 1.8 months.

Conclusion
The combination of MOR208 plus LEN is well tolerated and shows promising activity in patients with R-R DLBCL. Accrual and follow-up of patients is ongoing, as are cell of origin and other biomarker analyses.

Session topic: 20. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): Phase II, Monoclonal antibody, DLBCL, CD19

Abstract: S470

Type: Oral Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 17:00 - 17:15

Location: Hall C

Background
The Fc-enhanced CD19 antibody MOR208 and the immunomodulatory drug LEN have demonstrated single agent activity in patients with R-R DLBCL. MOR208 and LEN have shown synergy in vitro and in vivo in preclinical lymphoma models.

Aims
This ongoing phase II study was designed to assess the safety and efficacy of MOR208 plus LEN in patients with R-R DLBCL.

Methods
Patients >18 years of age with R-R DLBCL, ECOG performance status 0–2, adequate organ function, having previously received at least 1 but not more than 3 prior therapies, including at least 1 CD20-targeting regimen and who are not candidates for autologous stem cell transplant (ASCT), are eligible. Treatment comprises up to 12, 28-day cycles of MOR208 12 mg/kg IV, administered weekly during cycles 1–3 (loading dose day 4 of cycle 1) and every second week during cycles 4–12 plus LEN 25 mg administered po days 1–21 of each cycle. Patients progression-free after 12 cycles receive up to 12 additional cycles of MOR208 12 mg/kg IV, administered every second week. The primary endpoint is the overall response rate (ORR) by central radiology assessment. Secondary endpoints include disease control, duration of response, progression-free and overall survival, safety, and response by cell of origin and other biomarkers. A preplanned safety evaluation was undertaken.

Results
31 of 80 planned patients were enrolled prior to data cutoff (3 January 2017). Median age was 74 years (range 47–82); 45% of patients received ≥2 prior lines of therapy; 23% had rituximab refractory disease; 74% had Ann Arbor stage ≥III disease; 65% had elevated lactate dehydrogenase level, and 52% had a poor revised International Prognostic Index (3–5). The most common treatment-emergent adverse events (any grade/grade ≥3 [% patients]) were neutropenia (39/26), anemia (23/0) thrombocytopenia (16/6), infections (26/10) diarrhea (13/0), pyrexia (13/0), and rashes (13/6). Of 26 response evaluable patients (median follow-up 3.3 months), ORR (investigator assessed) was 58% (15 patients), with 7 (27%) complete responses. Median time to response was 1.8 months.

Conclusion
The combination of MOR208 plus LEN is well tolerated and shows promising activity in patients with R-R DLBCL. Accrual and follow-up of patients is ongoing, as are cell of origin and other biomarker analyses.

Session topic: 20. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): Phase II, Monoclonal antibody, DLBCL, CD19

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