We and our collaboration partner, Bristol-Myers Squibb Company (BMS), are currently testing elotuzumab as a new therapy for multiple myeloma.

We are evaluating elotuzumab as a second-line treatment in two phase 1 / 2 studies in patients with multiple myeloma: one in combination with Revlimid^® (lenalidomide) and low-dose dexamethasone and another in combination with Velcade^® (bortezomib).

At the American Society of Hematology (ASH) meeting in December 2009, we presented promising preliminary data from the phase 1 portion of the combination trial for elotuzumab and Revlimid^® (lenalidomide) plus low-dose dexamethasone. These data showed that of the 28 treated patients in this portion of the trial, 23 (82%) had an objective response by International Myeloma Working Group (IMWG) criteria. Further, a subset analysis showed that of 22 patients who had not previously received Revlimid^® (lenalidomide) treatment, 21 patients (95%) achieved an objective response. No dose-limiting toxicities were reported in the study up to 20 mg/kg elotuzumab and a maximum tolerated dose was not established. Two patients experienced serious adverse events of infusion reactions that were related to the administration of elotuzumab and were withdrawn from the study. These adverse events resolved with treatment. We also presented preliminary data from the ongoing combination trial of elotuzumab and Velcade^® (bortezomib).

We are currently enrolling patients into the phase 2 portion of the ongoing Phase 1 / 2 study of elotuzumab for the treatment of relapsed multiple myeloma in combination with Revlimid^® (lenalidomide) and low-dose dexamethasone. In the phase 2 portion of the study, up to 60 patients with relapsed multiple myeloma will be randomized to receive elotuzumab at 10 or 20 mg/kg in combination with lenalidomide and low-dose dexamethasone. The primary endpoint of the study is to evaluate objective response of the combination. Additional endpoints include safety, pharmacokinetics and pharmacodynamics.

Please visit our elotuzumab publications page to view our most recent data presentations for this program.

For inquiries about our clinical trials, please call our information line at 650 454-1400 or visit the National Institutes of Health website (http://www.clinicaltrials.gov).