Bristol-Myers Squibb Company and Abbott announced results from a small, randomized Phase 2, open-label study in patients with previously-treated multiple myeloma that evaluated two doses of elotuzumab (10 mg/kg and 20 mg/kg) in combination with lenalidomide and low-dose dexamethasone. In the 10 mg/kg arm, median progression-free survival (PFS), or the time without disease progression or death, was not reached after 20.8 months of follow up (N=36) and the objective response rate (ORR) was 92%. Of patients who received elotuzumab at a dose of 20 mg/kg, median PFS was 18.6 months (N=37) and ORR was 76%.

The safety data are consistent with previously-reported results for elotuzumab. Overall, 78% of patients experienced ≥1 treatment emergent grade ≥3 events. The most common were lymphopenia (19%), neutropenia (18%), thrombocytopenia (16%), anemia (12%), leukopenia (10%), hyperglycemia (10%), pneumonia (7%), diarrhea (7%), fatigue (7%), and hypokalemia (6%). Two deaths occurred on study (multiple adverse events [n=1; pneumonia, multiple organ failure and sepsis]; disease progression [n=1]). Infusion reactions (any grade) were reported in 14% of patients. Second primary malignancies were reported in four patients and were deemed as unrelated to elotuzumab.

These results were presented today during an oral session at the 54th Annual Meeting of the American Society of Hematology (ASH) in Atlanta and selected for presentation at Highlights of ASH.

“Multiple myeloma is the second most common blood cancer and remains incurable despite advances in treatment options over the last decade. In fact, there remains a high unmet medical need for patients, as almost all will eventually relapse and become refractory to currently available therapies,” said Paul G. Richardson, M.D. Clinical Director, Jerome Lipper Center for Multiple Myeloma, Dana-Farber Cancer Institute, lead author and principal investigator of the study. “The Phase 2 PFS data for elotuzumab presented today are encouraging and support further evaluation of this antibody in patients with multiple myeloma as part of large Phase 3 trials.”

Elotuzumab, an investigational immunotherapy, is a humanized monoclonal antibody that enhances immune cell mediated killing of multiple myeloma cells that have a surface protein called CS1. CS1 is a cell-surface glycoprotein that is highly expressed on myeloma cells.

“The data presented at ASH underscore Bristol-Myers Squibb’s dedication to seeking advances in care for patients with hematological malignancies,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “Elotuzumab, which is in Phase 3 development for multiple myeloma, is also an example of our commitment to develop immunotherapies and immuno-oncology approaches to help address areas of significant unmet medical need in a broad range of cancers.”

Two Phase 3 studies of elotuzumab in combination with lenalidomide and low-dose dexamethasone at a dose of 10 mg/kg are ongoing. The Phase 3 first-line multiple myeloma trial known as ELOQUENT-1 continues to enroll patients and the Phase 3 trial of patients with relapsed/refractory multiple myeloma known as ELOQUENT-2 is fully enrolled. A randomized Phase 2 study of bortezomib and dexamethasone with or without elotuzumab is also ongoing in patients with relapsed/refractory multiple myeloma.

Date: December 9, 2012
Source: Bristol-Myers Squibb Company