What is the indication for use of Empliciti?

ELOQUENT-2 demonstrated that the combination of a monoclonal antibody to SLAMF7 (Empliciti), an immunomodulatory drug (Revlimid), and an anti-inflammatory agent (dexamethasone, itself a modulator of immune activity) is an effective treatment for relapsed/refractory myeloma. In ELOQUENT-2, the benefit for PFS was consistent, even among elderly and high-risk patients. Another benefit was that the addition of Empliciti to Rd did not increase the incidence of negative side effects when compared to Rd alone. Data from the phase II ELOQUENT-3 clinical trial, presented at the European Hematology Association (EHA) meeting in June 2018, compared Empliciti + Pomalyst® (pomalidomide) + dexamethasone (EPd) to Pomalyst + dexamethasone (Pd) for treatment of relapsed/refractory myeloma. Study participants included 117 patients who had at least two prior lines of therapy and whose myeloma progressed despite treatment that included Revlimid and a proteasome inhibitor (Velcade® [bortezomib], Ninlaro® [ixazomib], or Kyprolis® [carfilzomib]). Patients treated with EPd had a longer remission duration (10.3 months) than patients treated with Pd (4.7 months), and the treatment had an acceptable safety profile. The FDA approved EPd for relapsed or treatment-resistant myeloma in November 2018.

Data from the SWOG-1211 randomized phase II clinical trial, which compared Revlimid + Velcade + dexamethasone (RVd) with and without Empliciti for newly diagnosed high-risk myeloma, were presented at the American Society of Clinical Oncology (ASCO) meeting in May 2020. The addition of Empliciti to RVd induction and maintenance did not improve patient outcomes for this patient population. However, the PFS and OS seen in both arms of the study exceeded the original statistical assumptions and support the role for combination maintenance therapy of proteasome inhibitors and immunomodulatory drugs. The data will serve as an important benchmark for future high-risk myeloma clinical trials. At this time, there are numerous completed, ongoing, or soon-to-be enrolling clinical trials with Empliciti in various myeloma disease settings and in combination with a wide variety of other drugs. Please visit the IMF’s Myeloma Matrix 2.0: Smart Search clinical trial search tool at matrix.myeloma.org for up-to-the-minute information.

In November 2015, the FDA approved Empliciti in combination with Revlimid + dexamethasone for the treatment of adult patients with myeloma who have received 1 to 3 prior therapies.