European Commission Approves Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Median progression-free survival and overall response rate doubled among patients receiving EPd compared to pomalidomide and low-dose dexamethasone alone

Second Empliciti-based combination approved in Europe for patients with relapsed and refractory multiple myeloma

PRINCETON, NJm USA I August 27, 2019 I Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Commission (EC) has approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy. This approval is based on data from the ELOQUENT-3 trial in which EPd doubled both median progression-free survival (PFS) and overall response rate (ORR) among patients with relapsed and refractory multiple myeloma versus pomalidomide and low-dose dexamethasone (Pd) alone.

“Multiple myeloma is a frequently recurring disease and the chance it will return after initial treatment is a heavy burden for patients to carry,” said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. “We are proud that the European Commission has again recognized the role of Empliciti in helping European patients with multiple myeloma by approving a second Empliciti-based regimen in the relapsed and refractory setting.”

EPd is the first triplet combination approved in Europe based on a randomized clinical trial using the standard of care, Pd, as a comparator. Results from ELOQUENT-3 demonstrated that the addition of Empliciti to Pd can significantly prolong survival without disease progression among heavily pretreated patients with multiple myeloma regardless of the number of prior therapies received. Investigator-assessed PFS, the study’s primary endpoint, was 10.25 months (95% CI: 5.59 to not estimable) among patients randomized to EPd compared with 4.67 months (95% CI: 2.83 to 7.16) among patients treated with Pd alone, indicating a 46% reduction in risk of disease progression (HR 0.54; 95% CI: 0.34 to 0.86; p=0.0078) between EPd and Pd arms after a minimum follow-up of 9.1 months. A secondary endpoint of the study, ORR, was 53.3% (95% CI: 40.0 to 66.3) compared with 26.3% (95% CI: 15.5 to 39.7; p=0.0029) among patients receiving EPd or Pd, respectively.

“The approval of this elotuzumab-based triplet combination in the relapsed and refractory setting gives patients, and their doctors, a treatment alternative shown to have the potential to offer patients more time living without disease progression, coupled with a tolerable safety profile,” said Meletios A. Dimopoulos, M.D., professor and chairman of the Department of Clinical Therapeutics at National and Kapodistrian University of Athens.

Data from the ELOQUENT-3 trial were first presented at the 23rd Congress of the European Hematology Association (EHA) in 2018. Updated efficacy results with a minimum follow-up of 18.3 months were presented at the 24th Congress of the EHA this year. In this exploratory analysis, a total of 40 (67%) patients were alive in the EPd arm and 29 (51%) patients were alive in the Pd arm (HR 0.54; 95% CI: 0.30 to 0.96). Median OS was not reached for the EPd treatment arm.

Treatment-related Grade 3-4 adverse events (AEs) were comparable between EPd and Pd groups. Any-grade infections occurred in 65% of patients in both arms. Rates of the most commonly occurring Grade 3-4 hematologic AEs, neutropenia and anemia, were 13% and 10%, respectively, for patients receiving EPd and 27% and 20%, respectively, for patients receiving Pd, despite longer exposure within the EPd arm and similar dose intensity of pomalidomide between arms. AEs led to discontinuation in 18% of patients in the EPd arm, compared with 24% of patients in the Pd arm.

The U.S. Food and Drug Administration (FDA) approved EPd for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI, in November 2018.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

About ELOQUENT-3

The Phase 2 ELOQUENT-3 trial randomized 117 patients with relapsed and refractory multiple myeloma to treatment with EPd (n=60) or Pd (n=57) in 28-day cycles until disease progression or unacceptable toxicity. In the EPd arm, Empliciti was administered intravenously at the dose of 10 mg/kg each week for the first 2 cycles and 20 mg/kg every four week thereafter. The median number of treatment cycles was nine for the EPd arm and five for the Pd arm.

Bristol-Myers Squibb: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.

About Empliciti

Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 also is expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Empliciti has a dual mechanism of action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.

Empliciti was initially approved by the FDA in 2015 in combination with lenalidomide and dexamethasone (ELd) for the treatment of patients with multiple myeloma who have received one to three prior therapies. In 2018, Empliciti was approved by the FDA in a new combination, with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI. The ELd and EPd indications were subsequently approved by the EC in 2016 and 2019, respectively.

U.S. FDA-APPROVED INDICATIONS FOR EMPLICITI®

EMPLICITI® (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.

EMPLICITI® (elotuzumab) is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumor types. For more information, please visit http://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html.

SOURCE: Bristol-Myers Squibb

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