Either Erik slept in today or all these results were already known to him. ;-)
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VELCADE(R) (Bortezomib) for Injection Shows Promising Activity in Two Phase II Studies of Patients With Non-Hodgkin's Lymphoma
CAMBRIDGE, Mass., Feb. 1 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) announced results from two clinical trials with VELCADE in patients with non-Hodgkin's lymphoma (NHL) published today in the Journal of Clinical Oncology (JCO). The data, in part presented at the 2004 American Society of Clinical Oncology (ASCO) meeting, were
findings from an ongoing phase II National Cancer Institute-sponsored study and final results from a phase II investigator initiated study examining the potential role of VELCADE in patients with various forms of NHL.
"We are very encouraged by the potential VELCADE demonstrated in these patients with aggressive and indolent lymphoma," said David Schenkein, M.D., vice president, clinical oncology development, Millennium. "These results support our goal of broadly exploring the use of VELCADE in a number of hematological cancers, and we look forward to presenting additional lymphoma data during the first half of this year."
Millennium and Johnson & Johnson Pharmaceutical Research and Development, L.L.C. are investigating VELCADE in both hematologic and solid tumors in trials throughout the U.S. and Europe.
In the National Cancer Institute-sponsored study led by Owen A. O'Connor, M.D., Ph.D., of Memorial Sloan-Kettering Cancer Center in New York, NY, patients with follicular, mantle cell, small lymphocytic and marginal zone lymphoma received single-agent VELCADE at 1.5 mg/m2 twice weekly for two weeks
every 21 days. There was no upper limit on planned therapy and treatment could continue as long as evidence of clinical benefit without excess toxicity. To be eligible for the study, patients must have received no more than three prior lines of therapy. Results included:
* A 58 percent overall response rate was observed in 24 evaluable patients of the 26 enrolled; patients received a median of four cycles of therapy;
* Seven of the nine evaluable patients with follicular lymphoma achieved objective remissions of their disease:
- One patient had a durable complete response;
- One patient had an unconfirmed complete response;
- Five patients had partial responses; and
- All responses were reported to be durable and ranged from three to 20 months with responses reported to be ongoing.
* A 50 percent overall response rate was seen in the 10 evaluable patients with mantle cell lymphoma:
- Five achieved major remissions;
- Four experienced stable disease; and
- All responses reported to be durable and ranged from six to 19 months with the median duration of response not reached.
* The two patients with nodal marginal zone lymphoma responded rapidly to bortezomib and duration of their responses to date exceed eight and 11 months; and
* Adverse events observed were generally manageable and included thrombocytopenia, lymphopenia, neuropathy, hypoatremia, hypokalemia, and prothrombin time.
"NHL is the most common hematologic cancer and the fifth most common cancer diagnosed in the United States each year, and since these lymphomas are not curable with standard treatment there is a growing need for new therapies," said Dr. O'Connor, Head of the Laboratory of Experimental Therapeutics for the Lymphoproliferative Malignancies at Memorial Sloan-Kettering Cancer Center. "These studies provide evidence of promising activity of bortezomib in patients with both indolent and aggressive types of NHL that failed multiple prior therapies, and the studies are now being expanded to multiple centers to accumulate further experience of the efficacy of bortezomib against these lymphomas."
In a separate, second study included in JCO, led by Andre Goy, M.D., of the University of Texas M.D. Anderson Cancer Center, studied patients 16 years of age or older, with relapsed or refractory B-cell NHL. There was no limitation in the number of prior systemic cytotoxic regimens or immunotherapy. Patients were stratified into two arms, one mantle cell lymphoma and one B-cell lymphomas. Patients received single agent VELCADE(R)
(bortezomib) for Injection at 1.5 mg/m2 twice weekly for two weeks every 21 days for up to six cycles. Results included:
* In the mantle cell lymphoma group, 12 of 29 (41 percent) evaluable patients responded to VELCADE treatment. Specifically:
- Six patients achieved complete responses;
- Six patients achieved partial responses;
- Approximately 80 percent of patients retained their response at six months; and
- The median time to progression has not been reached with a median follow-up of 8.5 months.
* In the B-cell lymphoma group, 4 of 21 (19 percent) evaluable B-cell lymphoma patients responded to VELCADE treatment with a median of two cycles of therapy administered.
- This patient population was heavily pre-treated, and had received an average of four prior therapies (with a range of one to 12).
* Adverse events observed were generally manageable and included thrombocytopenia, gastrointestinal events, fatigue, neutropenia, peripheral neuropathy, dizziness, and myalgia.
"Patients with MCL could be viewed as having the worst prognosis of all forms of lymphoma and are candidates for innovative therapy," wrote Richard Fisher, M.D., James P. Wilmot Cancer Center, University of Rochester Medical Center, in the accompanying JCO editorial, entitled Mantle Cell Lymphoma: At Last, Some Hope for Successful Innovative Treatment Strategies. "The study results in MCL patients are remarkably consistent and quite exciting. VELCADE is clearly active in follicular lymphoma and its utility will need to be
better defined in larger trials." |
