MILLENNIUM'S STUDY OF VELCADE IN MCL PUBLISHED IN JOURNAL

Millennium Pharmaceuticals announced that the Journal of Clinical Oncology has published the final results of the PINNACLE trial, one of the largest multicenter studies ever done in the setting of relapsed mantle cell lymphoma (MCL), according to the company. The results demonstrate the potential of Velcade as treatment for relapsed MCL, an aggressive form of non-Hodgkin's lymphoma (NHL). Velcade for relapsed MCL is under priority review with the FDA and a decision on the supplemental new drug application is expected in December.

The PINNACLE trial was one of several Phase II trials that consistently showed impressive response rates and duration of response. In this single-arm study, 155 patients with relapsed or refractory MCL who had received a maximum of two prior therapies received single-agent Velcade 1.3 mg/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 eight treatment cycles, and all patients in the study received a median of four cycles.

Results of the study, which was undertaken with Millennium's co-development partner, Johnson & Johnson Pharmaceutical R&D, showed a 33 percent overall response rate and an 8 percent complete response rate. 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.

Velcade currently is approved in the United States for the treatment of multiple myeloma patients who have received at least one prior therapy. Earlier this year, Millennium and Johnson & Johnson initiated a Phase III clinical trial with Velcade in combination with rituximab in patients with relapsed or refractory follicular and marginal zone lymphoma.