Millennium Pharmaceuticals, Inc., together with co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), has 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 potentially additive benefits of combining the activity of two targeted therapies with different mechanisms of action. Also already 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.

"Based on promising, single-agent response rates, we are moving forward with our clinical program to evaluate the benefits of Velcade based regimens in treating non-small cell lung cancer," David Schenkein, Senior Vice President, Clinical Development said adding, "We hope to demonstrate that these approaches may offer additional efficacy and safety benefits and may help patients with this advanced disease."

According to the company release, the Phase II randomized, open-label, multi-centre study will enrol approximately 135 patients. The primary endpoint is objective response rate (complete and partial response) as assessed by Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Secondary endpoints of the study include disease control rates (complete response, partial response and stable disease), 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. Velcade will be administered on a weekly schedule in both arms. The weekly dose of Velcade in this study is 1.6 mg/m2 and pemetrexed will be administered at the standard registered dose of 500 mg/m2.

Velcade is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. Velcade is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. Velcade should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.