Bristol Myers Squibb Reports Primary Results of ELOQUENT-1 Study Evaluating Empliciti (elotuzumab) Plus Revlimid (lenalidomide) and Dexamethasone in Patients with Newly Diagnosed, Untreated Multiple Myeloma

Phase 3 trial did not meet primary endpoint of progression-free survival in patients not eligible for transplant

PRINCETON, NJ, USA I March 9, 2020 IBristol Myers Squibb Company (NYSE: BMY) today announced topline results from ELOQUENT-1, a Phase 3, randomized, open-label trial evaluating the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd), in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. Both treatments were administered continuously until disease progression. At final analysis, the addition of Empliciti did not show a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint. The safety profile of ERd was generally consistent with the known profile of Empliciti plus Revlimid and dexamethasone. The company will complete a full evaluation of the ELOQUENT-1 data and work with investigators to present the results at a future medical meeting.

“While we are disappointed that the ELOQUENT-1 trial did not meet its primary endpoint in these previously untreated, transplant ineligible patients, the Empliciti, Revlimid and dexamethasone combination remains a standard treatment for patients with relapsed/refractory multiple myeloma, providing the potential for improved survival in this population of patients who are in need of additional treatment options,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb.

“Multiple myeloma is an aggressive disease characterized by relapse and the likelihood to be refractory to several therapies,” said Meletios A. Dimopoulos, M.D., professor and chairman of the Department of Clinical Therapeutics at Kapodistrian University of Athens School of Medicine. “While the elotuzumab, lenalidomide and dexamethasone combination was unable to show a benefit in patients with newly diagnosed multiple myeloma at this time, it remains an important treatment option in the relapsed/refractory setting.”

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

About ELOQUENT-1

ELOQUENT-1 is a Phase 3, randomized, open-label trial evaluating Revlimid and dexamethasone with or without Empliciti in patients with newly diagnosed, previously untreated multiple myeloma. The purpose of the study was to determine whether the addition of Empliciti to Revlimid and low-dose dexamethasone would improve PFS, the study’s primary endpoint. Secondary endpoints include objective response rate and overall survival.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase quality, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines 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 Revlimid and dexamethasone 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 Pomalyst/Imnovid (pomalidomide) and dexamethasone (EPd), for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The ELd and EPd indications were subsequently approved by the European Commission 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, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

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 https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html.

SOURCE: AbbVie

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