Millennium Pharmaceuticals Inc has initiated a phase II clinical trial of Velcade in patients with stage IIIb (locally advanced) or stage IV (metastatic) non-small cell lung cancer (NSCLC). The randomized, open-label study will assess response rates of patients with previously treated NSCLC to treatment with Velcade alone or Velcade plus Taxotere (docetaxel). Velcade is currently being investigated in a phase III study in patients with multiple myeloma and a range of phase I and II clinical trials in patients with hematologic and solid tumors.

"We are excited to be starting this phase II trial with Velcade because of the significant unmet medical need in NSCLC," said Robert Belt, of Oncology and Hematology Associates of Kansas City, MO, the first investigator to enroll and dose a patient in this study. "We are hopeful that the outcome of this trial with Velcade will provide a new treatment option for patients with NSCLC who have exhausted other therapies."

Velcade (bortezomib) for Injection is designed to specifically block proteasomes, which are enzyme complexes in the cell responsible for breaking down a variety of proteins, including many that regulate cell division. In preclinical studies, inhibition of the proteasome has been shown to lead to the disruption of cell cycle progression, resulting in cancer cell death (apoptosis). Velcade is the first and only proteasome inhibitor currently in clinical trials for treating cancer.

The clinical trial is being conducted at up to 20 sites in North America in approximately 155 patients with stage IIIb or IV, relapsed or refractory NSCLC. Up to 75 patients will be randomized to a treatment arm of Velcade alone and up to 80 patients to a combination arm consisting of Velcade and docetaxel. The primary endpoint of the study is tumor response as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

"The initiation of this trial in patients with NSCLC, our second company-sponsored phase II trial in solid tumors, is based on promising data from preclinical and phase I clinical solid tumor studies with Velcade," said Barry Greene, general manager, oncology at Millennium. "Millennium is committed to strategically and expeditiously growing the Velcade solid tumor program and anticipates reporting activity in up to four tumor types by the end of 2003."