>>ORLANDO, Fla., May 14 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced positive results from studies of VELCADE in lymphoma and lung cancer at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place this week in Orlando, Florida. Data for MLN2704, the Company's drug candidate for prostate cancer, were also presented. Results included:
* In relapsed patients with mantle cell lymphoma (MCL), interim results
of a multicenter phase II study of single-agent VELCADE showed median
survival had not been reached after 10.5 months of follow-up, and
demonstrated an overall response rate of 42 percent;
* In non-small cell lung cancer (NSCLC), final data from the single-agent
arm of the multicenter phase II trial of VELCADE with or without
docetaxel showed a response rate and overall survival comparable to
approved agents for use in second-line lung cancer; and
* In patients with late-stage, hormone-refractory prostate cancer,
interim phase I/II results of MLN2704 showed four of six patients
receiving a high dose achieved a reduction in prostate specific
antigen, including two with a greater than 50 percent reduction.
"These data demonstrate the growth potential of VELCADE and the strength of the Company's development programs in several areas including non-Hodgkin's lymphoma," said David Schenkein, M.D., senior vice president, clinical research, Millennium. "The early mantle cell data is consistent with results from four previously presented trials and is particularly exciting considering that these were heavily pre-treated patients and the toxicities were predictable and manageable."
VELCADE is approved in the U.S. for the treatment of patients who have received at least one prior therapy. Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) continue to investigate VELCADE globally in phase I, II and III clinical trials in both hematologic and solid tumors, including front-line MM, non-Hodgkin's lymphoma and lung, prostate and ovarian cancers.
VELCADE® (bortezomib) for Injection in Relapsed MCL (ASCO Abstract 6563)
The second-stage interim analysis of the PINNACLE phase II study led by Richard Fisher, M.D., University of Rochester, and presented by Andre Goy, M.D., Hackensack University Medical Center, Hackensack, NJ, showed the median survival for patients had not been reached at 10.5 months of follow up. Preliminary results from 48 evaluable patients included:
* Overall response rate of 42 percent with a complete and unconfirmed
complete response rate of eight percent;
* Median duration of response was 6.2 months and median time to
progression was 4.3 months;
* Patients received 1.3 mg/m(2) of VELCADE for a median of 4.5 cycles;
and
* Adverse events were similar to those observed in other clinical trials
and toxicities were found to be predictable and manageable and included
fatigue, peripheral neuropathy and gastrointestinal events.
Millennium was granted fast track status by the FDA for VELCADE in MCL in November 2004. In June, the Company will be presenting additional data from other lymphoma trials at the 9th International Conference on Malignant Lymphoma in Lugano, Switzerland.
VELCADE in Second-Line NSCLC (ASCO Abstract 7034)
Data from a multicenter phase II study, led by Joan Schiller, M.D., University of Wisconsin Comprehensive Cancer Center, and presented by Michael Fanucchi, M.D., Winship Cancer Institute, Emory University, Atlanta, GA, were reported. Investigator-assessed responses included:
Single agent results (n=75)
* Median survival of 7.4 months and one-year survival of 39 percent;
* Approximately eight percent achieved a partial response, and disease
control rate (stable disease or better) was 29 percent; and
* Median time to progression of 1.5 months.
Combination with docetaxel results (n=80)
* Median survival of 7.8 months and one-year survival of 33 percent;
* Approximately nine percent achieved a partial response and disease
control rate was 54 percent; and
* Median time to progression of 4 months.
Patients in the study received 1.5 mg/m(2) of VELCADE as a single agent biweekly or 1.3 mg/m(2) of VELCADE biweekly plus 75mg/m(2) of docetaxel on day one of every three weeks. Patients received a median of two cycles. Toxicities were manageable and adverse events were similar to those observed in other clinical trials of VELCADE such as gastrointestinal symptoms, fatigue and peripheral neuropathy.
Millennium and J&JPRD remain committed to further development and plan to commence randomized, phase II trials of VELCADE in combination with Tarceva (erlotinib) and Alimta (pemetrexed), two new therapies in the treatment of NSCLC. The companies also recently announced the initiation of the phase II PEAK trial in brochioloalveolar carcinoma.
MLN2704 in Late-stage Hormone Refractory Prostate Cancer (ASCO Abstract 4615)
Preliminary data from an ongoing multicenter, open label phase I/II clinical trial led by Howard Scher, M.D., Memorial Sloan-Kettering Cancer Center, and presented by Matthew Milowsky, M.D., Weill Medical College of Cornell University, were reported. Responses were evaluated based on a sustained 50 percent prostate specific antigen (PSA) decline and by measurable disease (RECIST criteria). Investigators reported the following results:
* Four of six patients receiving MLN2704 at 330mg/m(2) achieved a greater
than 25 percent reduction in PSA, two of which achieved a greater than
50 percent reduction;
* In the study overall (n=29), three patients achieved a decrease of PSA
greater than 50 percent that was sustained 10 weeks in one patient and
greater than 31 weeks in another patient. Five additional patients
achieved a decrease of PSA between 25 and 50 percent that was sustained
between four and 13 weeks;
* Of the seven patients with measurable disease, four achieved stable
disease by RECIST criteria; and
* Toxicities have been generally low-grade (Grade 1 and 2) and
manageable, including neutropenia, neuropathy, fatigue and
gastrointestinal symptoms; the only dose limiting toxicity was
increased serum alanine transaminase.
"MLN2704 is a conjugated monoclonal antibody that shows activity in prostate cancer tumors in a novel way," said Howard Scher, M.D., Chief of Genitourinary Oncology at Memorial Sloan-Kettering Cancer Center in New York, and the study's lead investigator. "We are continuing with early phase I/II trials to assess the optimal dose and schedule of MLN2704."<<
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Cheers, Tuck |
