Millennium and Johnson & Johnson Pharmaceutical Research and Development Initiate Phase III Clinical Trial with VELCADE(R) (bortezomib) for Injection in Follicular Non-Hodgkin's Lymphoma
CAMBRIDGE, Mass., April 18 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) along with co-development partner Johnson
& Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today
announced the initiation of a Phase III clinical trial of VELCADE in
combination with rituximab in patients with relapsed or refractory follicular
lymphoma, a subtype of non-Hodgkin's lymphoma (NHL). This study builds on
clinical data observed in previous trials of VELCADE that showed high
objective response rates and a favorable safety profile across a variety of
lymphomas.
"We accelerated the timeline for initiating this high-priority trial,"
said Robert Tepper, M.D., President, Research & Development, Millennium
Pharmaceuticals, Inc. "Based on previous study results that demonstrated
substantial single-agent and combination activity in this patient population,
we are excited about the potential of VELCADE to benefit patients with this
form of NHL, a disease that is not curable with standard therapy."
The Phase III study is expected to enroll approximately 670 patients with
relapsed or refractory, rituximab naive or sensitive follicular NHL. Patients
will be randomized to either the combination regimen of once-weekly VELCADE
plus rituximab or rituximab alone. The primary endpoint is progression-free
survival. Secondary endpoints of the study include the overall response rate
and duration of response as assessed by the International Workshop to
Standardize Response Criteria for NHL (IWRC). The weekly dose of VELCADE in
this study is 1.6 mg/m2 and rituximab will be administered at 375 mg/m2.
This study builds on previous clinical trials results of VELCADE in NHL,
including data from a Phase II study presented in December 2005 at the 47th
Annual Meeting of the American Society of Hematology. In a randomized, multi-
center Phase II study comparing weekly and twice-weekly VELCADE in combination
with the standard-weekly dose of rituximab, the more convenient weekly arm
showed a response rate similar to that of the twice-weekly arm, with an
improved safety profile. Results from the 74 evaluable patients (39 in the
weekly arm and 35 in the twice-weekly arm) included overall response rates,
including complete responses, of 54 percent in the weekly arm, and 51 percent
in the twice-weekly arm with a similar total amount of drug received in both
treatment arms. Additionally, data presented at the 9th International
Conference of Malignant Lymphoma in Lugano, Switzerland in June 2005
demonstrated response rates for single-agent VELCADE as high as 56 percent in
patients with relapsed or refractory follicular lymphoma. The most common
adverse events seen in these trials were gastrointestinal symptoms,
neutropenia, thrombocytopenia, fatigue and peripheral neuropathy.
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