Facet, Bristol-Myers Squibb Report Positive Phase I/II Interim Data On Elotuzumab

Facet Biotech (Facet) and Bristol-Myers Squibb have reported positive data from a phase I/II study of Elotuzumab, an investigational humanised antibody being studied for the treatment of relapsed multiple myeloma (MM).

The ongoing phase I/II study of Elotuzumab plus Lenalidomide and low-dose Dexamethasone, evaluated multiple doses of Elotuzumab in patients with multiple myeloma. The interim results showed that of the 28 treated patients in the trial, 23 had an objective response (OR) by International Myeloma Working Group (IMWG) criteria. A subset analysis showed that of 22 patients who had not previously received lenalidomide treatment, 21 patients have achieved an OR.

Reportedly, the primary objective of the phase I/II study is to evaluate the maximum tolerated dose (MTD) of Elotuzumab in combination with Lenalidomide and low dose Dexamethasone in patients with relapsed MM. The study is also evaluating safety, pharmacokinetics (PK) and clinical response. Elotuzumab in three escalating dose cohorts (5, 10 and 20mg/kg) is administered by IV infusion.

Interim results of another phase I/II study of Elotuzumab plus Bortezomib in 20 evaluable patients, eight patients, 40%, had an OR and 60% achieved a clinical response, defined as minimal response or better using the combined European Group for Blood and Marrow Transplant (EBMT) and IMWG criteria. The study continues to enroll patients at the 20mg/kg dose level.

Faheem Hasnain, president and CEO of Facet, said: “The preliminary data show that Elotuzumab in combination with Lenalidomide and Dexamethasone may have potential as a treatment option for patients with multiple myeloma. We are working closely with our partners at Bristol-Myers Squibb to finalise next steps for the Elotuzumab development program, and anticipate initiating a global Phase II study in the first half of 2010.”