• 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

Princeton, NJ and North Chicago, IL (Press Release) – 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 inno­va­t 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.

Source: Bristol-Myers Squibb and AbbVie.