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Ref Type Journal Article
PMID (31672767)
Authors Ghobrial IM, Liu CJ, Redd RA, Perez RP, Baz R, Zavidij O, Sklavenitis-Pistofidis R, Richardson PG, Anderson KC, Laubach J, Henrick P, Savell A, Reyes K, Hornburg K, Chuma S, Sabbatini P, Robbins MD, Becker PS
Title A Phase Ib/II Trial of the First-in-Class Anti-CXCR4 Antibody Ulocuplumab in Combination with Lenalidomide or Bortezomib Plus Dexamethasone in Relapsed Multiple Myeloma.
Journal Clinical cancer research : an official journal of the American Association for Cancer Research
Vol 26
Issue 2
Date 2020 Jan 15
URL
Abstract Text Ulocuplumab (BMS-936564) is a first-in-class fully human IgG4 monoclonal anti-CXCR4 antibody that inhibits the binding of CXCR4 to CXCL12.This phase Ib/II study aimed to determine the safety and tolerability of ulocuplumab alone and in combination with lenalidomide and dexamethasone (Arm A), or bortezomib and dexamethasone (Arm B), in patients with relapsed/refractory multiple myeloma.Forty-six patients were evaluated (median age, 60 years; range, 53-67). The median number of prior therapies was 3 (range, 1-11), with 70% of subjects having received ≥3. This trial had a dose-escalation and a dose-expansion part. Using a 3+3 design on both arms of the trial, ulocuplumab's dose was escalated to a maximum of 10 mg/kg without reaching MTD. The most common treatment-related adverse events (AE) were neutropenia (13 patients, 43.3%) in Arm A and thrombocytopenia (6 patients, 37.5%) in Arm B. No deaths related to study drugs occurred. The combination of ulocuplumab with lenalidomide and dexamethasone showed a high response rate (PR or better) of 55.2% and a clinical benefit rate of 72.4%, even in patients who had been previously treated with immunomodulatory agents (IMiD).This study showed that blockade of the CXCR4-CXCL12 axis by ulocuplumab is safe with acceptable AEs and leads to a high response rate in combination with lenalidomide and dexamethasone in patients with relapsed/refractory myeloma, making CXCR4 inhibitors a promising class of antimyeloma drugs that should be further explored in clinical trials.

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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
Ulocuplumab BMS-936564|MDX1338 CXCR4 Inhibitor 15 Ulocuplumab (BMS-936564) is a monoclonal antibody that binds to CXCR4 and prevents binding of SDF-1 (CXCL12), potentially resulting in increased apoptosis and decreased migration of tumor cells (PMID: 23213054, PMID: 31672767).
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 multiple myeloma not applicable Bortezomib + Dexamethasone + Ulocuplumab Phase I Actionable In a Phase I trial, Ulocuplumab (BMS-936564) in combination with Velcade (bortezomib) and Adexone (dexamethasone) demonstrated safety and preliminary efficacy, resulted in an overall response rate of 25.0% (4/16) and a clinical benefit rate of 50% (8/16) in patients with relapsed multiple myeloma (PMID: 31672767). 31672767
Unknown unknown multiple myeloma not applicable Dexamethasone + Lenalidomide + Ulocuplumab Phase I Actionable In a Phase I trial, Ulocuplumab (BMS-936564) in combination with Revlimid (lenalidomide) and Adexone (dexamethasone) demonstrated safety and preliminary efficacy, resulted in an overall response rate of 55.2% (16/29) and a clinical benefit rate of 72.4% (21/29) in patients with relapsed multiple myeloma (PMID: 31672767). 31672767