UPDATE OF THE SINGLE-ARM PHASE II L-MIND STUDY OF MOR208 PLUS LENALIDOMIDE IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: HIGH OVERALL RESPONSE RATES IN PATIENT SUBGROUPS WITH POOR PROGNOSIS
Author(s): ,
Johannes Duell
Affiliations:
Medizinische Klinik und Poliklinik II,Universitätsklinik Würzburg,Würzburg,Germany
,
Kami Maddocks
Affiliations:
Department of Internal Medicine, Division of Hematology,The Ohio State University Comprehensive Cancer Center,Columbus, Ohio,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
,
Zsolt Nagy
Affiliations:
First Department of Internal Medicine,Semmelweis University,Budapest,Hungary
,
Aleš Obr
Affiliations:
Department of Hemato-Oncology,Palacký University Olomouc and the University Hospital Olomouc,Olomouc,Czech Republic
,
Gianluca Gaidano
Affiliations:
Division of Haematology, Department of Translational Medicine,University of Eastern Piedmont,Novara,Italy
,
Marc André
Affiliations:
Department of Hematology,Université Catholique de Louvain, CHU UCL Namur,Yvoir,Belgium
,
Nagesh Kalakonda
Affiliations:
Department of Haemato-oncology,Clatterbridge Cancer Centre and University of Liverpool,Liverpool,United Kingdom
,
Martin Dreyling
Affiliations:
University Hospital of Ludwig-Maximilians-Universität,Munich,Germany
,
Pier Luigi Zinzani
Affiliations:
Institute of Hematology “L. e A. Seràgnoli”, University of Bologna,Bologna,Italy
,
Maren Dirnberger-Hertweck
Affiliations:
MorphoSys AG,Planegg,Germany
,
Johannes Weirather
Affiliations:
MorphoSys AG,Planegg,Germany
,
Sumeet Ambarkhane
Affiliations:
MorphoSys AG,Planegg,Germany
Gilles Salles
Affiliations:
Hospices Civils de Lyon,Centre Hospitalier Lyon Sud, Service d'Hématologie,Pierre Bénite,France
EHA Library. DÜLL J. Jun 14, 2019; 266096; PF296
Johannes DÜLL
Johannes DÜLL
Contributions
Abstract

Abstract: PF296

Type: Poster Presentation

Presentation during EHA24: On Friday, June 14, 2019 from 17:30 - 19:00

Location: Poster area

Background
The CD19 antigen is broadly and homogeneously expressed across different B-cell malignancies, including relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL). MOR208, an Fc-enhanced, humanized, anti-CD19 monoclonal antibody has shown single agent activity in patients (pts) with R-R DLBCL and encouraging activity when combined with lenalidomide (LEN) in the single-arm phase II L-MIND study. Here we report updated data for the primary endpoint and patient subgroup analyses (data cutoff of June 5, 2018).   

Aims
To assess the efficacy and safety of MOR208 combined with LEN in pts with R-R DLBCL.  

Methods
Key inclusion criteria were adequate organ function, ≤3 prior lines of therapy, including ≥1 anti-CD20 therapy, and ineligibility for stem cell transplantation. Treatment comprised up to 12, 28-day (d) cycles (C) of MOR208, 12 mg/kg IV, weekly C1–3 (loading dose on d4 of C1), and every two weeks C4–12 plus LEN 25 mg PO d1–21, C1–12. Pts progression-free after 12 C received MOR208 every two weeks until progression. The primary endpoint was independent review committee (IRC)-assessed overall response rate (ORR) as per Cheson 2007 criteria. Secondary endpoints included investigator (INV)-assessed ORR, duration of response, progression-free survival (PFS) and overall survival (OS), safety, and analysis of outcomes according to cell of origin. 

Results
Recruitment is complete with 81 pts enrolled and analyzed for safety and efficacy. Median age was 72 years (range 41–87), 41 (51%) pts had received ≥2 prior lines of therapy (median 2, range 1–4), 19 (23%) pts had early relapse (≤12 months from initial diagnosis), 32 (40%) pts were rituximab refractory (no response to or progression during or within 6 months of a prior rituximab therapy), 34 (42%) pts were refractory to their last therapy, 21 (26%) pts had non-germinal center B cell-like (GCB)-DLBCL and 40 (49%) had GCB-DLBCL, and 42 (52%) pts had an International Prognostic Index (IPI) of 3–5. MOR208 plus LEN therapy was well tolerated, and 58 (72%) of pts stayed on a LEN dose of ≥20 mg/day. Treatment-related serious adverse events consisted of infections (10%) and neutropenic fever (5%). No infusion-related reactions were reported. Investigator (INV)-assessed complete response (CR) and partial response rates were 33% and 25%, respectively, giving an ORR of 58%. IRC-assessed ORR and CR rates were 54% and 32%, respectively. INV-assessed ORR was 70% in pts with 1 prior therapy, 46% in pts with ≥2 prior therapies, 59% in rituximab-refractory pts, 56% in last treatment-refractory pts, 58% in early relapse pts, 57% in pts with a baseline IPI of 3-5, and 71% in pts with non-GCB-DLBCL and 53% in pts with GCB-DLBCL, respectively. At a median follow-up of 12 months, the INV-assessed median PFS and OS (intention-to-treat analysis) were 16.2 months (95% CI: 6.3 months–NR) and not reached (95% CI: 18.6 months–NR), respectively. 

Conclusion
The combination of MOR208 and LEN has shown encouraging activity including a durable PFS in elderly pts with R-R DLBCL. High activity and long lasting responses were also reported in patient subgroups with poor prognosis, who urgently need effective therapies.   

 

Session topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): Diffuse large B cell lymphoma, Refractory

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