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Published on 6/5/2006 in the Prospect News Biotech Daily.

Millennium's Velcade data shows improved survival in advanced lung cancer

By Elaine Rigoli

Tampa, Fla., June 5 - Millennium Pharmaceuticals, Inc. announced the final results from a phase 2 study conducted by the Southwest Oncology Group that showed a median survival of 11 months for patients with non-small cell lung cancer treated with a Velcade-based regimen.

This compared favorably to the historic nine-month survival seen in past Southwest Oncology Group studies with a two-drug platin-based regimen, a current standard of care, in patients with non-small cell lung cancer, according to a news release.

The phase 2 single-arm, multi-institutional study assessed the safety and efficacy of Velcade in combination with gemcitabine (GEM) and carboplatin in 114 chemo-naïve patients with stage 4 and selected stage 3B non-small cell lung cancer.

Patients received GEM 1,000 mg/m2 days one and eight, and carboplatin AUC 5 on day one, followed one hour later by Velcade 1.0 mg/m2 days one, four, eight and 11.

Other findings included the following:

• One-year survival of 47% with five-month progression-free survival;

• Overall response rate of 20% and stable disease of 66%;

• Therapy well tolerated. The most common hematological toxicities were neutropenia and thrombocytopenia, and the most common non-hematological adverse events were fatigue and gastrointestinal events.

Millennium is a biopharmaceutical company based in Cambridge, Mass.


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