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01.12.2014 | PHASE I STUDIES | Ausgabe 6/2014

Investigational New Drugs 6/2014

Phase 1b study of otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR™ therapeutic protein, in combination with rituximab and bendamustine in relapsed indolent lymphoma patients

Zeitschrift:
Investigational New Drugs > Ausgabe 6/2014
Autoren:
Ajay K. Gopal, Stefano R. Tarantolo, Naresh Bellam, Damian J. Green, Melissa Griffin, Tatyana Feldman, Anthony R. Mato, Amy J. Eisenfeld, Scott C. Stromatt, Andre Goy
Wichtige Hinweise
Presented at ASH Annual Meeting 2012

Summary

Purpose CD37 is cell surface tetraspanin present on normal and malignant B cells. Otlertuzumab (TRU-016) is a novel humanized anti-CD37 protein therapeutic that triggers direct caspase independent apoptosis of malignant B cells and induces antibody-dependent cell-mediated cytotoxicity. This study evaluated the safety, pharmacokinetics, and efficacy of otlertuzumab administered in combination with rituximab and bendamustine to patients with relapsed, indolent B-cell non-Hodgkin Lymphoma (NHL). Methods Patients with relapsed or refractory NHL received otlertuzumab (10 or 20 mg/kg) intravenously (IV) on days 1 and 15, bendamustine (90 mg/m2) on days 1 and 2, and rituximab (375 mg/m2) on day 1 for up to six 28 day cycles. Responses were determined using standard criteria. Results Twelve patients were treated with 6 patients at each dose level; median age was 57 years (range, 51–79), and median number of prior regimens was 3 (range, 1–4). All patients had relapsed after prior rituximab including 7 refractory to their most recent previous treatment. In the 10 and 20 mg/kg dose cohorts, the mean half-life was 8 and 10 days following the first dose, and 12 or 14 days following 12 doses of otlertuzumab, respectively. Overall response rate was 83 % (10/12) with 4 CRs (32 %). The most frequent adverse events were neutropenia, nausea, fatigue, leukopenia, and insomnia; most were grade 1 or 2. Conclusions Otlertuzumab in combination with rituximab and bendamustine was well tolerated and induced responses in the majority of patients with relapsed indolent B-NHL. NCI Clinical Trials Network registration: NCT01317901.

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