Facet Biotech Corporation (Nasdaq: FACT) and Bristol-Myers
Squibb Company (NYSE: BMY) announced that potentially promising data
from a Phase I/II study of elotuzumab, an investigational humanized
antibody being studied for the treatment of relapsed multiple myeloma
(MM), were presented today at the American Society of Hematology (ASH)
2009 Annual Meeting in New Orleans.
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 given as an oral
presentation today showed that of the 28 treated patients in the trial,
23 (82 percent) 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 (95 percent) achieved an OR.
No dose-limiting toxicities (DLT) were reported in the study up to the
highest dose level of 20 mg/kg and a maximum-tolerated dose (MTD) was
not established. Two patients experienced serious adverse events of
allergic reactions that were related to elotuzumab and were withdrawn
from the study. These adverse events resolved with treatment. In
addition, other adverse events reported for the combination of
lenalidomide, dexamethasone and elotuzumab, regardless of causality to
disease or study drugs, included fatigue, diarrhea, constipation,
myelosupression, nausea, muscle spasms, fever, chills and dyspnea.
Enrollment for the Phase I portion of the study is completed.
“The preliminary data presented today show that elotuzumab in
combination with lenalidomide and dexamethasone may have potential as a
treatment option for patients with multiple myeloma,” said Faheem
Hasnain, president and chief executive officer of Facet Biotech. “We are
working closely with our partners at Bristol-Myers Squibb to finalize
next steps for the elotuzumab development program, and anticipate
initiating a global Phase II study in the first half of 2010.”
“We, along with our partner, Facet Biotech, are focusing on the
investigation of combinations of potential treatments in the hopes of
identifying a more efficacious and tolerable option for patients to help
them when faced with this serious disease,” said Brian
Daniels, M.D., senior vice president, Global Development & Medical
Affairs, Bristol-Myers Squibb.