VELCADE(R) (Bortezomib) for Injection May Offer New Standard of Care in Relapsed/Refractory Mantle Cell Lymphoma
- Efficacy data to support regulatory filing this year -
ATLANTA, June 4 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc.
(Nasdaq: MLNM) today announced results of a clinical study that showed the
efficacy of single-agent VELCADE in the treatment of relapsed or refractory
mantle cell lymphoma. These Phase II data were presented at the American
Society of Clinical Oncology (ASCO) 42nd Annual Meeting in Atlanta, June 2-6,
2006. Overall response rate, including complete responses, was 33 percent with
a median duration of response of 9.2 months. These data are anticipated to be
the basis for the Company's submission of a supplemental new drug application(sNDA) shortly.
"These results may offer new hope for the management of mantle cell
lymphoma, which represents the most challenging subtype of lymphoma," said
Andre Goy, M.D., Chief of The Division of Lymphoma, The Cancer Center at
Hackensack University Medical Center in Hackensack, N.J. "Moreover, they
reinforce the safety and efficacy observed in multiple other Phase II studies
of VELCADE which showed its potential to become a new standard of care for
relapsed patients."
VELCADE in Relapsed or Refractory Mantle Cell Lymphoma (MCL): Results of
the PINNACLE Study (Abstract 7512)
The Phase II prospective, single-arm study led by Drs. Richard Fisher and
Andre Goy assessed the safety and efficacy of VELCADE in 155 patients with
relapsed or refractory MCL with a maximum of two prior therapies. Patients
received single-agent VELCADE 1.3mg/m2 twice weekly for two weeks every 21
days for up to one year. Patients achieving complete response (CR),
unconfirmed complete response (CRu) or partial response (PR) received a medina
of eight treatment cycles and all patients on study received a median of four
cycles. Study results included:
* Overall response rate of 33 percent (CR + CRu + PR)
* Complete response rate of 8 percent (CR+CRu)
* Median duration of response (DOR) of 9.2 months, 13.5 months in
patients achieving complete response
* Median time to progression (TTP) of 6.2 months
* Median treatment-free interval of 13.8 months in patients achieving a complete response
* Treatment 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.
These results contribute to the growing body of evidence supporting
VELCADE in the treatment of relapsed or refractory MCL, including four other
Phase II clinical trials showing overall response rates of 30 to 40 percent.
Millennium anticipates submitting a sNDA for relapsed MCL with the Food and
Drug Administration (FDA) shortly. Earlier this year, the Company, together
with its co-development partner, Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), initiated a Phase III clinical trial of VELCADE
in combination with rituximab in patients with relapsed or refractory
follicular lymphoma, another subtype of non-Hodgkin's lymphoma.
"This study represents a major advancement in the treatment of mantle cell
lymphoma and, as planned, we will be seeking FDA approval," said Robert
Tepper, M.D., President, Research & Development, Millennium. "The results also
provide further evidence of the potential clinical benefits of VELCADE in
treating hematological cancers beyond multiple myeloma."
About Non-Hodgkin's Lymphoma
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