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withdrawn from the study.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.
"These interim results are of significant scientific and clinical
interest. I am very encouraged by the efficacy and safety data seen to
date for this combination, which may offer a future treatment option
for multiple myeloma patients," said Sagar Lonial, M.D., of the
Winship Cancer Institute at Emory University in Atlanta. "Given that
elotuzumab, a humanized antibody, has a novel mechanism of action
that appears to work synergistically with lenalidomide, we look
forward to advancing clinical studies with this antibody to determine
its full potential, with the goal of ultimately improving outcomes
for myeloma patients."
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 20 mg/kg) is administered by IV infusion.
Interim results from another Phase I/II study were also presented
today at the ASH annual meeting. In a study of elotuzumab plus
bortezomib in 20 evaluable patients, eight patients, 40 percent, had
an OR and 60 percent achieved a clinical response, defined as minimal
response or better using the combined European Group for Blood and
Marrow Transplant (EBMT) and IMWG criteria. No DLTs were reported and
an MTD was not established. The study continues to enroll patients at
the 20 mg/kg dose level.
About Elotuzumab
Elotuzumab is a humanized monoclonal antibody directed against CS1, a
cell-surface glycoprotein that is highly and uniformly expressed on
multiple myeloma cells but is minimally expressed on normal cells. In
nonclinical studies, elotuzumab has been shown to induce
antibody-dependent cellular cytotoxicity (ADCC) against primary
myeloma cells and is currently in Phase I/II clinical development.
Source
Facet Biotech
and
Bristol-Myers Squibb