bristol-myers squibb co (BMY) Snapshot

Bristol-Myers Squibb Company and AbbVie Inc. 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 on June 15, 2013 at the 18(th) Annual Congress of the European Hematology Association (EHA) in Stockholm, Sweden.

Bristol-Myers Squibb Company and Simcere Pharmaceutical Group announced that the companies have expanded their strategic relationship formed in 2010. The companies have agreed to collaborate in China on the development and commercialization of the subcutaneous (SC) formulation of Bristol-Myers Squibb's biologic medicine, Orencia(R) (abatacept), for the treatment of rheumatoid arthritis. Orencia SC is already on the market for the treatment of rheumatoid arthritis in the U.S., Europe and Japan. Under the terms of the agreement, Simcere will perform and fund all development and regulatory activities required to obtain market approval for Orencia SC in China, based on a pre-agreed development plan. The companies will share responsibility for commercializing Orencia, and will share profits and losses related to Orencia SC in China. Financial terms were not disclosed.

Bristol-Myers Squibb Company announced the results of year two data from AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis (RA) Subjects With Background Methotrexate), a trial of 646 patients comparing the subcutaneous (SC) formulation of ORENCIA(R) (abatacept) vs. Humira(R) (adalimumab), each on a background of MTX, in biologic naïve patients with moderate to severe RA. The AMPLE year two data are being presented this week at the European League Against Rheumatism (EULAR) annual congress and highlighted during a congress press conference. AMPLE met its primary endpoint as measured by non-inferiority of ACR20 (American College of Rheumatology 20% improvement) at year one. The ORENCIA regimen achieved comparable rates of efficacy vs. the Humira regimen (64.8% vs. 63.4%, respectively). Onset of response was also generally similar for the two groups. Year two of the study remained investigator-blinded. At year two, the ORENCIA regimen achieved the same rate of efficacy (60%) as the Humira regimen based on ACR20. ACR50, 70, and 90, considered to be more stringent measures of efficacy, as well as DAS-28-CRP, were assessed over 24 months and were generally similar for the two arms. Radiographic progression was also assessed at two years with 85% of patients on the ORENCIA regimen and 84% of patients on the Humira regimen achieving radiographic non-progression. At 24 months, overall safety data were similar for both groups, including frequency of adverse events (92.8% and 91.5%), serious adverse events (13.8% and 16.5%), and malignancies (2.2% and 2.1%) for the ORENCIA regimen and the Humira regimen, respectively. Discontinuations due to adverse events were 3.8% for the ORENCIA regimen and 9.5% for the Humira regimen, while discontinuations due to serious adverse events were 1.6% for the ORENCIA regimen and 4.9% for the Humira regimen. Additionally, zero of the 12 patients who experienced serious infections in the ORENCIA group discontinued, while nine of the 19 patients who experienced serious infections in the Humira group discontinued. Autoimmune events, of mild or moderate severity, were reported in 3.8% of patients in the ORENCIA group and 1.8% of patients in the Humira group. Injection site reactions were reported in 4.1% of patients taking the ORENCIA regimen and 10.4% of patients taking the Humira regimen. AMPLE is a phase IIIb randomized, investigator-blinded multinational study of 24 months duration with a 12 month efficacy primary endpoint (non-inferiority for ACR20). The study included 646 adult biologic-naïve patients with active moderate to severe RA and inadequate response to MTX; 318 in the ORENCIA plus MTX group and 328 in the Humira plus MTX group. Patients were stratified by disease activity and randomized to either 125 mg ORENCIA SC weekly or 40 mg Humira every other week, both on background MTX. The primary endpoint was to determine non-inferiority of ORENCIA plus MTX to Humira plus MTX based on ACR20 response at 12 months. Of 646 patients who were randomized and treated, 79.2% (252 of 318) ORENCIA plus MTX patients and 74.7% (245 of 328) Humira plus MTX patients completed the full 24 month study. Comparable ACR20 response rates at year two were 59.7% for ORENCIA plus MTX and 60.1% for Humira plus MTX.