VELCADE(R) (Bortezomib) for Injection Demonstrated High Single-Agent Response Rates in Newly Diagnosed Multiple Myeloma Patients
- Market leader in relapsed myeloma continues to show consistently high response rates in front-line setting -
ATLANTA, June 4 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc.
(Nasdaq: MLNM) today announced new clinical data for the treatment of multiple
myeloma (MM) that underscore the potential benefit of using VELCADE upfront in
newly diagnosed patients. Data, reported at the American Society of Clinical
Oncology (ASCO) 42nd Annual Meeting in Atlanta, June 2-6, 2006, showed an
overall response rate of 40 percent as a single agent, including a complete
response rate of 10 percent. These data provide further rationale for several
Phase II studies of VELCADE in combination with other therapies that
consistently have shown some of the highest recorded response rates, including
complete responses, in the treatment of front-line MM.
"These single-agent results further demonstrated that VELCADE may provide
a strong foundation for combining with other agents in the treatment of newly
diagnosed patients," said Paul Richardson, M.D., Principal Investigator, from
the Dana-Farber Cancer Institute in Boston, Mass. "Emerging data such as these
offer real hope that we may continue to improve outcomes for multiple myeloma
patients, and do so with less toxicity than other approaches, such as those
involving cytotoxic chemotherapy and/or high dose dexamethasone."
Single-agent VELCADE (bortezomib) in Previously Untreated Multiple Myeloma: Results of a Phase II Multicenter Study (Abstract 7504)
The Phase II prospective, single-arm study led by Dr. Richardson assessed
the safety and efficacy of VELCADE in 66 patients with untreated, symptomatic
MM. Patients received single-agent VELCADE 1.3mg/m2 twice weekly for two weeks
every 21 days for eight cycles. Response rates were measured using the Blade
criteria. The following results were reported:
* Overall response rate of 40 percent including a complete response rate
of 10 percent and a 30 percent partial response rate.
* Therapy well tolerated. Side effects included peripheral neuropathy,
fatigue and rash, which were mild to moderate in almost all cases.
Importantly, no thrombosis was seen and in those patients with
peripheral neuropathy, symptoms improved or resolved in 75 percent of
cases through dose reduction or after treatment was completed.
Growing Body of Evidence
Previous studies in relapsed MM have demonstrated single-agent VELCADE has
an unprecedented survival advantage. In newly diagnosed patients, VELCADE
based therapies have achieved transplant-like results with overall response
rates of up to 95 percent and complete and near complete response rates of up
to 43 percent. To date, over 33,000 MM patients have been treated with VELCADE
worldwide.
"The results of this study add to the growing body of data that support
our aggressive registration strategy to move VELCADE into the front-line MM
setting," said Robert Tepper, M.D., President, Research & Development,
Millennium. "If interim data from at least one of our three, Phase III front-
line trials are strong, there may be an opportunity for early registration.
This could potentially double the number of patients who would benefit from
VELCADE based regimens."
Millennium and co-development partner Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. (J&JPRD) are currently investigating the
potential benefit of VELCADE in the treatment of newly diagnosed MM patients,
both eligible and ineligible for transplant, in three Phase III registration
trials. Interim data from one of the Phase III registration trials are
anticipated later this year.
About Multiple Myeloma
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