Corporate news details

Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced that results from an interim analysis of its Phase III, randomized, open-label ELOQUENT-2 trial were published in the June 2 online edition of the New England Journal of Medicine. The trial (n=646) evaluated elotuzumab, an investigational immunostimulatory antibody, in combination with lenalidomide and dexamethasone (ELd) versus lenalidomide and dexamethasone alone (Ld) for the treatment of relapsed or refractory multiple myeloma. The study met its co-primary endpoints demonstrating superior progression-free survival (PFS) and overall response rate (ORR).

The ELd arm demonstrated a 30% reduction in the risk of disease progression or death compared to the Ld arm (HR 0.70, 95% CI, [0.57, 0.85]; p = 0.0004). The PFS rates in the ELd arm versus the Ld arm were 68% versus 57% at 1 year and 41% versus 27% at 2 years, respectively. A significant ORR also was observed with 79% (74% to 83%) in the ELd arm compared to 66% (60% to 71%) in the Ld arm (odds ratio, 1.9; 1.4 to 2.8; p=0.0002). The safety profile was consistent with previously-reported studies and there were minimal incremental adverse events (AEs) with the addition of elotuzumab to lenalidomide and dexamethasone.

“Despite advances in treatment, multiple myeloma remains a largely incurable disease,” said lead author Sagar Lonial, M.D., chief medical officer of the Winship Cancer Institute of Emory University School of Medicine. “These ELOQUENT-2 data are significant because they show that adding elotuzumab to the standard treatment yielded an impressive reduction in the risk of disease progression, which was maintained over time, demonstrating the benefit of an immune-based approach in multiple myeloma.”

Results from the ELOQUENT-2 trial will be presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago during an Oral Abstract Session on Tuesday, June 2 from 9:45 – 9:57 a.m. CDT [Abstract # 8508].

Also presented in a poster session at ASCO on Sunday, May 31 were results from the Phase II study that evaluated elotuzumab in combination with bortezomib and dexamethasone (EBd, n=77) versus bortezomib and dexamethasone (Bd, n=75) alone in patients with relapsed or refractory multiple myeloma [Abstract #8573]. Consistent with data from ELOQUENT-2, results from the Phase II study demonstrated a 28% reduction in the risk for disease progression or death in the EBd arm compared to Bd alone (HR 0.72, 70% CI, 0.59, 0.88). One-year PFS rates were 39% (95% CI 28%, 50%) for EBd versus 33% (95% CI 22%, 44%) for Bd. One-year survival rates were 85% (95% CI 75%, 92%) in the EBd arm versus 74% (95% CI 62%, 83%) in the Bd arm. Grade 3-4 AEs were reported in 68% of patients in the EBd group and 60% in the Bd group, including infections (19% vs. 15%), thrombocytopenia (9% vs. 17%), and peripheral neuropathy (8% vs. 9%).

“These trials, which evaluated elotuzumab in combination with either an IMiD or a proteasome inhibitor, demonstrated that elotuzumab, an immunostimulatory antibody, has the potential to be a new modality for the treatment of multiple myeloma,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Bristol-Myers Squibb continues to make great progress toward delivering on our commitment to expand the role of immunotherapy into hematologic malignancies, such as multiple myeloma. We look forward to continued follow-up of the ELOQUENT-2 trial as we know improvement in long-term outcomes, including survival, is critical for patients.”

About ELOQUENT-2

ELOQUENT-2 (CA204-004) is an open-label, multicenter Phase III study evaluating elotuzumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma. The trial enrolled 646 patients who had received one to three prior therapies and who were not lenalidomide-refractory. Patients were randomized 1:1 to receive either elotuzumab 10 mg/kg in combination with lenalidomide and dexamethasone (ELd) or lenalidomide and dexamethasone alone (Ld) in 28-day cycles to disease progression or unacceptable toxicity. The co-primary endpoints were progression-free survival, as defined by hazard ratio, and objective response rate. Median follow-up for this interim analysis was 24.5 months with 35% of ELd patients (n=113) and 21% of Ld patients (n=66) remaining on therapy. Key secondary endpoints included overall survival and pain severity/interference with daily life. Exploratory objectives included tumor response, duration of response, health-related quality of life, and safety.

Along with a 30% reduction in the risk of disease progression, which was sustained at two years, the median PFS in the ELd group was 19.4 months (95% CI, 16.6 to 22.2) versus 14.9 months (95% CI, 12.1 to 17.2) in the Ld group. The PFS benefit observed was consistent across all pre-specified subgroups. Patients in the ELd arm were exposed to treatment with lenalidomide 30% (or median of approximately five months) longer than patients in the Ld arm. Discontinuation was mainly due to disease progression (42% ELd, 47% Ld). The rate of discontinuation due to adverse events did not differ between arms. Grade 3-4 hematologic adverse events in the ELd and Ld arms, respectively, included lymphopenia (77% vs. 49%), neutropenia (34% vs. 44%), anemia (19% vs. 21%) and thrombocytopenia (19% vs. 20%), and the exposure-adjusted infection rate was the same in both arms. Infusion reactions occurred in 10% of patients with ELd; these were mostly Grade 1-2, and were manageable and resulted in discontinuation in only 1% of patients. A similar proportion of patients in each study group (2%) died due to an adverse event. As of this analysis, there were a total of 210 deaths in the study with 94 [30%] in the ELd group versus 116 [37%] in the Ld group. This represents a total of 49% of the 427 deaths required for the final analysis. Follow-up of longer-term outcomes, including overall survival, is ongoing.

About Elotuzumab

Elotuzumab is an investigational immunostimulatory antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7), a cell-surface glycoprotein that is highly and uniformly expressed on myeloma cells and Natural Killer (NK) cells, but is not detected on normal solid tissues or on hematopoietic stem cells. Elotuzumab is being investigated to determine whether the compound may selectively target myeloma cells. It is believed that elotuzumab works through a dual mechanism of action: binding to SLAMF7 on NK cells, directly activating them and binding to SLAMF7 on myeloma cells, flagging them for NK cell recognition and destruction.

In May 2014, the U.S. Food and Drug Administration (FDA) granted elotuzumab Breakthrough Therapy Designation for use in combination with one of the chemotherapy treatments for multiple myeloma (lenalidomide, used in combination with dexamethasone) in patients who have received one or more prior treatments. Elotuzumab is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

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

About Multiple Myeloma

Multiple myeloma is a hematologic, or blood, cancer that develops in the bone marrow. It occurs when a plasma cell, a type of cell in the soft center of bone marrow, becomes cancerous and multiplies uncontrollably. Despite advances in multiple myeloma treatment over the last decade, only 45% of patients have a 5-year survival rate. A common characteristic for many patients is that they experience a cycle of remission and relapse, in which they stop treatment for a short time, but eventually return to a treatment shortly after. Following relapse, less than 20% of patients are alive after five years. It is estimated that annually, more than 114,200 new cases of multiple myeloma are diagnosed and more than 79,000 people die from the disease globally.

Immuno-Oncology at Bristol-Myers Squibb

Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.

To address this unmet medical need, Bristol-Myers Squibb is leading research in an innovative field of cancer research and treatment known as Immuno-Oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining Immuno-Oncology agents that target different pathways in the treatment of cancer.

Bristol-Myers Squibb is committed to advancing the science of Immuno-Oncology, with the goal of changing survival expectations and the way patients live with cancer.

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 www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that elotuzumab will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

AbbVie Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the likelihood that the transaction is consummated, the expected benefits of the transaction, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.