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
Year: 2017
Type: article
Study design: Clinical Trial
Abstract: Introduction: 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. 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. Conclusions: 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. Keywords: CD19; diffuse large B-cell lymphoma (DLBCL); lenalidomide.
Source: Hematological Oncology
DOI: 10.1002/hon.2437_35
Institutions: Hospices Civils de Lyon, Hôpital Lyon Sud, Institut d'Investigació Biomédica de Bellvitge, Institut Català d'Oncologia, Duran i Reynals Hospital, Jagiellonian University, Azienda Ospedaliera S.Maria, Universitätsklinikum Würzburg, Semmelweis University, University Hospital Olomouc, Palacký University Olomouc, UCLouvain, Royal Liverpool University Hospital, LMU Klinikum, Ludwig-Maximilians-Universität München, University of Bologna, MorphoSys (Germany), The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2621700964