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Ref Type Journal Article
PMID (28314788)
Authors Soumerai JD, Zelenetz AD, Moskowitz CH, Palomba ML, Hamlin PA, Noy A, Straus DJ, Moskowitz AJ, Younes A, Matasar MJ, Horwitz SM, Portlock CS, Konner JA, Gounder MM, Hyman DM, Voss MH, Fury MG, Gajria D, Carvajal RD, Ho AL, Beumer JH, Kiesel B, Zhang Z, Chen A, Little RF, Jarjies C, Dang TO, France F, Mishra N, Gerecitano JF
Title The PARP Inhibitor Veliparib Can Be Safely Added to Bendamustine and Rituximab and Has Preliminary Evidence of Activity in B-Cell Lymphoma.
Journal Clinical cancer research : an official journal of the American Association for Cancer Research
Vol 23
Issue 15
Date 2017 Aug 01
URL
Abstract Text Purpose: The PARP inhibitor veliparib enhances the cytotoxicity of alkylating agents. This phase I study evaluated veliparib with the bifunctional alkylator bendamustine (VB) in patients with relapsed/refractory lymphoma, multiple myeloma, and solid malignancies, with a cohort expansion of VB with rituximab (VBR) in patients with B-cell lymphomas.Experimental Design: This dose-escalation study evaluated safety, pharmacokinetics, and preliminary efficacy of veliparib (20-400 mg twice a day, days 1-7 of 28-day cycle) and bendamustine (70 and 90 mg/m2 intravenously, days 1 and 2). A cohort expansion was conducted, which combined veliparib and bendamustine at the maximum tolerated dose (MTD) with rituximab (375 mg/m2, day 1) in patients with B-cell lymphomas. Thirty-four patients were treated in seven dose-escalation cohorts and seven patients in the dose-expansion cohort.Results: The MTD was veliparib 300 mg twice daily plus bendamustine 90 mg/m2 Dose-limiting toxicities (DLT) were anemia, nausea, hypertension, and hyperhidrosis. Grade ≥3 toxicities included lymphopenia (87.8%), anemia (19.5%), neutropenia (12.2%), thrombocytopenia (9.8%), leukopenia (9.8%), nausea (7.3%), and hypophosphatemia (7.3%). Apparent veliparib clearance was slightly lower than previously reported. Of 14 patients with lymphoma evaluable for response, five of seven (71%) on VB and six of seven (86%) on VBR achieved objective response. One patient with multiple myeloma achieved partial response.Conclusions: VB and VBR were generally well-tolerated. VBR had preliminary clinical activity in patients with B-cell lymphoma, which warrants further investigation in a phase II trial. This trial was registered at www.clinicaltrials.gov as NCT01326702 Clin Cancer Res; 23(15); 4119-26. ©2017 AACR.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown follicular lymphoma not applicable Bendamustine + Veliparib Phase I Actionable In a Phase I trial, a patient with follicular lymphoma treated with a combination of Veliparib (ABT-888) and Bendamustine demonstrated a complete response (PMID: 28314788; NCT01326702). 28314788
Unknown unknown multiple myeloma not applicable Bendamustine + Veliparib Phase I Actionable In a Phase I trial, a patient with multiple myeloma demonstrated a partial response when treated with a combination of Bendamustine and Veliparib (ABT-888) (PMID: 28314788; NCT01326702). 28314788
Unknown unknown Advanced Solid Tumor not applicable Bendamustine + Veliparib Phase I Actionable In a Phase I trial, the combination of Bendamustine and Veliparib (ABT-888) resulted in stable disease in 63% (12/19) of patients with advanced solid tumors (PMID: 28314788; NCT01326702). 28314788
Unknown unknown non-Hodgkin lymphoma not applicable Bendamustine + Rituximab + Veliparib Phase I Actionable In a Phase I trial, seven patients with non-Hodgkin lymphoma treated with a combination of Veliparib (ABT-888), Bendamustine, and Rituxan (rituximab) demonstrated an overall response rate of 86% (6/7) and a complete response rate of 71% (5/7), and a progression free survival of 14.2 months (PMID: 28314788; NCT01326702). 28314788
Unknown unknown lymphoma not applicable Bendamustine + Veliparib Phase I Actionable In a Phase I trial, seven patients with lymphoma treated with a combination of Veliparib (ABT-888) and Bendamustine demonstrated an overall response rate of 71% (5/7) and complete response rate of 57% (4/7) and progression free survival of 6.9 months (PMID: 28314788; NCT01326702). 28314788
Unknown unknown follicular lymphoma not applicable Bendamustine + Rituximab + Veliparib Phase I Actionable In a Phase I trial, five patients with follicular lymphoma treated with a combination of Bendamustine, Rituxan (rituximab), and Veliparib (ABT-888) demonstrated a complete response (PMID: 28314788; NCT01326702). 28314788