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Friday, June 14, 2019

Bristol-Myers Updates Efficacy Data from Phase 2 Multiple Myeloma Trial

  • In a descriptive analysis, addition of Empliciti to pomalidomide and dexamethasone reduced risk of death by 46% among patients with RRMM
  • Empliciti-based combination showed improvements across efficacy endpoints, including continued progression-free survival benefit at 18 months
Bristol-Myers Squibb Company (NYSE: BMY) today announced the presentation of updated data from ELOQUENT-3, the international randomized Phase 2 study evaluating Empliciti (elotuzumab) plus pomalidomide and dexamethasone (EPd) versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM). In a non-prespecified analysis conducted to provide a descriptive assessment of overall survival (OS) after extended follow-up of at least 18.3 months, patients treated with EPd continued to experience sustained and clinically relevant OS and progression-free survival (PFS) benefits compared with patients treated with Pd.
Treatment with EPd was associated with a 46% reduction in risk of death [Hazard Ratio (HR) 0.54; 95% Confidence Interval (CI): 0.30 to 0.96] versus treatment with Pd alone. At 18 months, rates of OS, a secondary endpoint, were 68% for patients treated with EPd compared to 49% for patients treated with Pd. Median OS was not reached with EPd [95% CI: 24.9 months, Not Estimable (NE)] at the time of analysis and was 17.4 months (95% CI: 13.8, NE) among patients receiving Pd. Eighteen-month PFS rates were 34% among patients randomized to EPd compared to 11% among patients randomized to Pd. Safety results for EPd were consistent with the primary analysis and with prior findings for Empliciti and pomalidomide regimens.
These data will be presented at the 24th Congress of the European Hematology Association (EHA) in Amsterdam in a poster display (Abstract #PS1370) on Saturday, June 15 from 5:30-7 PM CEST.

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