Millennium, J&JPRD Begin More Velcade Studies

Millennium Pharmaceuticals and co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) have initiated a three-arm, randomized, Phase II study of Velcade and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior chemotherapy treatment. The study will assess the potential benefits of combining the activity of two targeted therapies with different mechanisms of action. Also underway is a two-arm, randomized, Phase II study of Velcade in combination with erlotinib for patients with locally advanced or metastatic NSCLC and a study of single-agent Velcade in relapsed bronchioalveolar carcinoma and adenocarcinoma of the lung. In newly diagnosed patients with NSCLC, a study to evaluate Velcade in combination with other agents has recently been completed.

The Phase II randomized, open-label, multi-center study will enroll approximately 135 patients. The primary endpoint is objective response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Secondary endpoints of the study include disease control rates, time to progression, progression-free survival and safety. Patients will be assigned to one of three treatment groups: Velcade in combination with pemetrexed, pemetrexed alone or Velcade alone.