Pipeline Asset Update for BMS-901608
Pipeline Asset: BMS-901608, an anti-CS1 antibody under investigation for the treatment of multiple myeloma (MM)
Current Phase of Development: Phase II
Meeting or Publication: American Society of Clinical Oncology (ASCO) 2010
Study Title: Elotuzumab in Combination with Lenalidomide and Low Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma: A Phase I/II Study
ClinicalTrial.gov Identifier: NCT00742560
Abstract Number: 8020
Date/Time of Presentation: Sunday, June 6, 2010, at noon CDT, 1 p.m. EDT
Media Embargo: Per ASCO Press Guidelines this oral presentation is under embargo until the publication of the 2010 ASCO Annual Meeting Proceedings, Part 1 at 6:00 p.m. EDT May 20, 2010.
Primary Study Objective: Establish the maximum tolerated dose (MTD) of elotuzumab in combination with lenalidomide and low dose dexamethasone in the treatment of relapsed or refractory MM. Pharmacokinetics and efficacy are also being evaluated.
Study Conclusion:
  • In the Phase I study of 28 treated patients with a median of three prior MM therapies, no dose-limiting toxicities (DLTs) were observed in the dose-escalation phase. MTD was not reached up to the highest dose of 20 mg/kg.
  • Overall response rate (partial response (PR) or better) in 23/28 (82%) patients including 21/22 (95%) lenalidomide-naїve patients
  • Phase II expansion is ongoing to further examine efficacy and identify the optimal dose of elotuzumab (10 mg/kg vs 20 mg/kg) in combination with lenalidomide and low dose dexamethasone (NCT00742560)
Efficacy Results:
  • The overall response rate was 23/28 (82%) in all treated patients.
  • In the lenalidomide-naive patients, the overall response rate was 22/23 (95%).
  • In the patients who were refractory to most recent treatment, the overall response rate was 10/12 (83%).
  • After a median of eight cycles follow up, the median time to progression has not been reached.
Adverse Events:
  • Two severe adverse events related to elotuzumab infusion reactions (stridor and hypersensitivity) were reported.
  • Other severe adverse events (AEs) included neutropenia, thrombocytopenia, fatigue, anemia, diarrhea, constipation and hypokalemia.
  • The most frequent AEs (any grade) include: fatigue, anemia , diarrhea and nausea.
BMS-901608 Background:
  • Elotuzumab is an investigational first-in-class humanized monoclonal IgG1 antibody to a surface protein called CS1. CS1 is highly and uniformly expressed on MM cells, but is not common on most normal cells, which may allow specific targeting of tumor cells.
  • Elotuzumab is being developed in collaboration with Abbott.
Study Background:
  • Phase Ib (3+3) dose escalation cohorts evaluated elotuzumab 5, 10, and 20 mg/kg IV in combination with lenalidomide 25 mg PO and low dose dexamethasone PO
  • First five patients were limited to six cycles of therapy. The remaining 23 patients were treated until disease progression or unacceptable toxicity, if earlier
  • Phase II expansion cohort is randomizing approximately 60 patients in 1:1 ratio to either 10 or 20 mg/kg elotuzumab
  • Key Inclusion
    • Relapsed MM with ≥1 prior therapies
    • Measurable disease by M protein
    • Creatinine clearance ≥50 mL/min (Cockcroft-Gault method)
  • Key Exclusion
    • Thalidomide, bortezomib, or corticosteroids within two weeks of the first dose
    • Prior lenalidomide within six weeks of the first dose
Request for More Information and Media Interviews: Investors: John Elicker, 609-252-4611, john.elicker@bms.com
Media: Jennifer Fron Mauer, 609-252-6579, jennifer.mauer@bms.com
Supporting information: The abstract can be viewed on the ASCO website here.