BMS, AbbVie: PFS in Phase II Elotuzumab Study

Bristol-Myers Squibb and AbbVie Announce Progression-Free Survival Data from Phase 2 Open-Label Study of Investigational Agent Elotuzumab in Combination with Lenalidimide and Dexamethasone in Previously-Treated Multiple Myeloma

•Median progression-free survival (PFS) of 33 months reached after longer-term follow up in patients treated with elotuzumab 10 mg/kg plus lenalidomide and low-dose dexamethasone

•Longer-term safety profile of the combination consistent with previously reported results

•Results Presented at 18th Annual Congress of the European Hematology Association

•Two Phase 3 studies of elotuzumab at 10 mg/kg dose ongoing in patients with previously-treated and newly-diagnosed multiple myeloma

"The Phase 2 data on elotuzumab are encouraging and support further evaluation in Phase 3 trials."

PRINCETON, N.J. & NORTH CHICAGO, Ill., June 15, 2013--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and AbbVie (NYSE: ABBV) today announced updated efficacy and safety data from a small, randomized Phase 2, open-label study in patients with previously-treated multiple myeloma that evaluated two doses of the investigational monoclonal antibody elotuzumab (10 mg/kg and 20 mg/kg) in combination with lenalidomide and low-dose dexamethasone. In the 10 mg/kg arm (N=36), which is the dose used in the ongoing Phase 3 trials, median progression-free survival (PFS), or the time without disease progression, was 33 months after a median follow-up of 20.8 months (95% CI: 14.9-NA) and the objective response rate (ORR) was 92%. As previously reported, median PFS was 18 months in the 20 mg/kg arm (N=37) after a median follow-up of 17.1 months (95% CI: 12.912-32.361) and ORR was 76%.

The safety data were consistent with previously-reported results for elotuzumab from this trial. In patients receiving elotuzumab 10 mg/kg or 20 mg/kg, most treatment-emergent adverse events occurred within 18 months of initiating therapy. The most common Grade 3/4 adverse events (seen in > 5% of patients) for the 10 mg/kg and 20 mg/kg arms respectively were lymphopenia (26% and 9%), neutropenia (21% and 22%), thrombocytopenia (21% and 17%), anemia (13% and 12%), leukopenia (8% and 7%), hyperglycemia (5% and 12%), pneumonia (8% and 5%), diarrhea (10% and 5 %), fatigue (8% and 9%), and hypokalemia (8% and 5%). As previously reported at the 2012 American Society of Hematology annual meeting, two deaths occurred on study (multiple adverse events [n=1; pneumonia, multiple organ failure and sepsis]).

These data were presented today at the 18th Annual Congress of the European Hematology Association (EHA) in Stockholm, Sweden. (Abstract #14)

“There remains a high unmet medical need for patients with multiple myeloma, the second most common blood cancer, as many may relapse and stop responding to currently available treatments,” said Thierry Facon, MD, Hospital Claude Huriez, Service des Maladies du Sang, Lille, France. “The Phase 2 data on elotuzumab are encouraging and support further evaluation in Phase 3 trials.”

About the Phase 2 Study

In the phase 2 study, patients with relapsed/refractory multiple myeloma were randomized 1:1 to receive elotuzumab 10 or 20 mg/kg (IV infusion on days 1, 8, 15, and 22 of a 28-day cycle in the first 2 cycles and then days 1 and 15 of subsequent cycles) in combination with lenalidomide 25 mg PO daily on days 1 to 21 and dexamethasone 40 mg PO weekly. Patients were treated until disease progression or unacceptable toxicity, if earlier. Objective response rate was the study’s primary endpoint per response criteria established by the International Myeloma Working Group. Secondary endpoints in the trial include PFS and safety.

About Elotuzumab

Elotuzumab, an investigational compound in Phase 3 development, is a humanized monoclonal antibody that targets a cell-surface protein called CS1 that is highly expressed on multiple myeloma cells.

Studies of elotuzumab in combination with lenalidomide and low-dose dexamethasone at a dose of 10 mg/kg are ongoing. ELOQUENT-1, a Phase 3 trial in first-line multiple myeloma trial is currently enrolling patients and a second Phase 3 trial of patients with relapsed/refractory multiple myeloma (ELOQUENT-2) is fully enrolled. Elotuzumab is also being investigated in a randomized Phase 2 study of bortezomib and dexamethasone with or without elotuzumab in relapsed or refractory multiple myeloma.

About Multiple Myeloma

Multiple myeloma is a type of cancer that originates in the white blood cells. It is the second most common blood cancer with an annual incidence of more than 100,000 worldwide and a 5-year survival rate of 41% in newly-diagnosed patients. In 2013, it is estimated that approximately 22, 350 new cases will be diagnosed in the U.S. and that 10,710 people will die from the disease.

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 moreinformation 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. 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. In 2013, AbbVie employs approximately 21,000 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 Statements

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 clinical trials of the compound described in this release will support a regulatory filing or that the compound will receive regulatory approval or become a commercially successful product. Forward-looking statements in the 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, 2012, its Quarterly Reports on Form 10-Q, and 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, 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 our 2012 Annual Report on Form 10-K/A, 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.

Contact:

Bristol-Myers Squibb

Media

Sarah Koenig, 609-252-4145

sarah.koenig@bms.com

Melanie Brunner, 609-252-6338

melanie.brunner@bms.com

or

Investors

Ranya Dajani, 609-252-5330

ranya.dajani@bms.com

Ryan Asay, 609-252-5020

ryan.asay@bms.com

or

AbbVie

Media

David Freundel, 847-937-4522

david.freundel@abbvie.com

or

Investors

Liz Shea, 847-935-2211

elizabeth.shea@abbvie.com
 

Posted: June 2013

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