Millennium, Johnson & Johnson Pharmaceutical start Velcade trial for lung cancer

By Elaine Rigoli

Tampa, Fla., March 6 - Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, LLC announced Monday the beginning of a three-arm, randomized, phase 2 study of Velcade and pemetrexed in multiple myeloma patients with locally advanced or metastatic non-small cell lung cancer 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, according to a company news release.

"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," said David Schenkein, Millennium senior vice president of clinical development, in a company statement.

"We hope to demonstrate that these approaches may offer additional efficacy and safety benefits and may help patients with this advanced disease," he added.

The phase 2 randomized, open-label, multi-center study will enroll about 135 patients.

The primary endpoint is objective response rate (complete and partial response) as assessed by Response Evaluation Criteria in Solid Tumors, the release said.

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.

Millennium and Johnson & Johnson Pharmaceutical are investigating Velcade in both hematologic and solid tumors in trials throughout the United States and Europe.

Velcade is approved in more than 60 countries, including the United States, most of Europe, and a number of countries within Latin America and Southeast Asia.

Millennium is a biopharmaceutical company based in Cambridge, Mass.

Johnson & Johnson Pharmaceutical is a research and development company based in Raritan, N.J.

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