Published study results show that adding new immunotherapy elotuzumab to standard treatment for multiple myeloma significantly reduced risk of disease progression

• 30% reduction in risk of disease progression or death; 2-year progression-free survival (PFS) rate of 41% in the elotuzumab arm versus 27% in the control arm

MONTREAL, June 3, 2015 /CNW/ - Bristol-Myers Squibb and AbbVie announced that the addition of investigational immunotherapy, elotuzumab, to standard treatment for multiple myeloma, a blood cancer, showed significant reduction in the risk of disease progression and a higher two-year progression-free survival (PFS) rate.  These study results were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and simultaneously published in the New England Journal of Medicine.

The results come from an interim analysis of the Phase III, randomized, open-label ELOQUENT-2 trial (n=646) which evaluated elotuzumab, an investigational immunostimulatory antibody, in combination with standard therapy 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.

"The results from the ELOQUENT-2 study are important because they demonstrate that an immunotherapy approach to treating multiple myeloma, in addition to standard therapy, can positively impact patient survival," said Dr. Darrell White, hematologist, Queen Elizabeth II Health Sciences Centre, and professor of medicine at Dalhousie Medical School. "We've reached a point in the management of multiple myeloma where new treatment approaches are needed to improve survival rates."

Also presented in a poster session at ASCO 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%).

"While significant developments have been made in the treatment of multiple myeloma in the past decade, patients are in need of new and different ways to manage this cancer. Today, to quote Aldo Del Col, co-founder of Myeloma Canada, we are living through the 'golden age' of myeloma research," said Francine Gendron, Chief Executive Officer of Myeloma Canada. "As part of that experience, the first phase III data we are seeing for an immuno-oncology agent in multiple myeloma is very positive. This is a very exciting time for the myeloma community." 

About ELOQUENT-2
ELOQUENT-2 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).

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.

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, the five-year survival rate is only 45%. 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. An estimated 7,500 Canadians are living with multiple myeloma.ⁱ In 2014 it is estimated 2,600 new cases were diagnosedⁱⁱ and 1,400 Canadians died from the disease.ⁱⁱⁱ The disease affects more men than women; 57% of new Canadian myeloma cases in 2014 were in men, 43% in women.^iv Most diagnoses were in people over age 60.^v

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 Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, 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 global operations, visit www.bms.com. Bristol-Myers Squibb Canada has been delivering innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, neuroscience, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada employs over 300 people across the country. For more information, please visit www.bmscanada.ca.

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.

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i} Myeloma Canada, Multiple Myeloma Patient Handbook, Incidence and Prevalence in Canada, p. 8. Accessed at: http://www.myelomacanada.ca/docs/ph_en_2014_lr.pdf
ⁱⁱ Canadian Cancer Society, Canadian Cancer Statistics 2014, p. 24.
ⁱⁱⁱ Canadian Cancer Society, Canadian Cancer Statistics 2014, p. 45.
^iv Canadian Cancer Society, Canadian Cancer Statistics 2014, p. 24.
^v Myeloma Canada, Multiple Myeloma Patient Handbook, Incidence and Prevalence in Canada, p. 8. Accessed at: http://www.myelomacanada.ca/docs/ph_en_2014_lr.pdf

SOURCE Bristol-Myers Squibb Canada

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