Journal of Clinical Oncology Publishes Final Study Results of VELCADE(R) (Bortezomib) for Injection in Relapsed Mantle Cell Lymphoma
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-- Study results formed basis of supplemental new drug application (sNDA) filing for relapsed mantle cell lymphoma --
CAMBRIDGE, Mass., Oct. 6 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that the Journal of
Clinical Oncology has published the final results of the PINNACLE trial, one
of the largest multi-center studies ever done in the setting of relapsed
mantle cell lymphoma (MCL). The results demonstrate the potential of VELCADE
as treatment for relapsed MCL, an aggressive form of non-Hodgkin's lymphoma
(NHL). The study, which provided the major source of data for the sNDA filing
for VELCADE in relapsed MCL, was prepublished online in the September 25, 2006
Journal of Clinical Oncology and will run in the October 20, 2006 print issue.
VELCADE for relapsed MCL is under Priority Review with the U.S. Food and Drug
Administration (FDA) and a decision is expected by December 9, 2006.
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"The publication in Journal of Clinical Oncology highlights the potential
of VELCADE in the treatment of mantle cell lymphoma," said Deborah Dunsire,
M.D., President and CEO, Millennium. "The study, one of several Phase II
trials which consistently showed impressive response rates and duration of
response, suggests that VELCADE may become a standard component of therapy in
this disease."
Results of the study, which was undertaken with Millennium's
co-development partner, Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), showed a 33 percent overall response rate and an
8 percent complete response rate. Importantly, the median overall duration of
response was 9.2 months, and 13.5 months in patients who achieved a complete
response. These results are consistent with those of four
investigator-initiated Phase II clinical trials where overall response rates
of 30 to 40 percent with single-agent VELCADE were observed.
PINNACLE Study
In this prospective, single-arm study, 155 patients with relapsed or
refractory MCL who had received a maximum of two prior therapies, received
single-agent VELCADE 1.3mg/m2 twice weekly for two weeks every 21 days for up
to one year. Patients achieving complete response, unconfirmed complete
response or partial response received a median of 8 treatment cycles, and all
patients in the study received a median of 4 cycles. Study results included:
* Overall response rate of 33 percent
* Complete response rate of 8 percent
* Median duration of response of 9.2 months; 13.5 months in patients
achieving a complete response
* Median time to progression of 6.2 months
* Median treatment-free interval of 13.8 months in patients achieving a
complete response
* Treatment was well tolerated. The most common non-hematologic adverse
events were fatigue, gastrointestinal events and peripheral neuropathy.
Hematologic toxicities were consistent with those previously seen with
VELCADE.
VELCADE currently is approved in the United States for the treatment of
multiple myeloma (MM) patients who have received at least one prior therapy.
To date, over 44,000 MM patients have been treated with VELCADE for MM
worldwide, including clinical trials. Earlier this year, Millennium and
co-development partner, J&JPRD, initiated a Phase III clinical trial with
VELCADE in combination with rituximab in patients with relapsed or refractory
follicular and marginal zone lymphoma.
About Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
NHL is the most common hematological cancer, the fifth leading cause of
cancer death and the second fastest growing form of cancer in the U.S.(1) The
prevalence of NHL is approximately 400,000 patients, 77,000 patients with
follicular lymphoma and 10,000 with mantle cell lymphoma. There are
approximately 54,000 new cases of NHL diagnosed per year, and 19,000 deaths
are attributed to the disease annually(2,3).
MCL is an aggressive, rapidly progressive subtype of NHL, and is not
curable with standard treatment. Because there is no generally accepted
treatment approach and options are often limited, there is a growing need for
new therapies. The average life expectancy for a patient with relapsed MCL is
one to two years.
About VELCADE
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