New myeloma trial results; two new studies initiated

CAMBRIDGE, Massachusetts—Interim results of the large international phase III VISTA trial in patients with newly diagnosed multiple myeloma showed a significant improvement in all efficacy measures for bortezomib (Velcade), melphalan, and prednisone vs melphalan/prednisone.

Based on the recommendation of an independent data monitoring committee, the control arm of the trial was stopped early to allow patients still being treated with melphalan/prednisone to have bor-tezomib added to their therapy, Millennium Pharmaceuticals, Inc. announced in a press release.

"These results position Velcade-based therapy as a new standard of care for newly diagnosed multiple myeloma patients," said Paul Richardson, MD, associate professor of medicine, Harvard Medical School, and a lead investigator of the VISTA trial. "The combination of Velcade with melphalan and prednisone surpassed all efficacy endpoints, including time to disease progression, complete remission rate, progression-free survival, and overall survival, and did so much earlier than expected. We are excited at the possibility that this new therapy could be available to our patients sooner than expected."

Based on the trial data, Millennium plans to file a supplemental new drug application with FDA in the first quarter of 2008 for use of Velcade in patients with newly diagnosed multiple myeloma. The agent is currently approved for myeloma patients who have received at last one prior therapy. The company expects the VISTA trial results to be presented in December at the American Society of Hematology annual meeting.

Temsirolimus/bortezomib trial

In other myeloma news, the Multiple Myeloma Research Consortium has announced the initiation of a multicenter phase I/II clinical program to explore the combination of the mTOR inhibitor temsirolimus (Torisel) and bortezomib for the treatment of relapsed or refractory myeloma.

The phase I component of the trial will evaluate the safety of the combination and identify the maximum tolerated dose of the combination as well as a recommended dose for phase II study. The phase II component will evaluate response to the combination.

Tanespimycin trials

Kosan Biosciences, Hayward, California, has reached a binding agreement with FDA on the design of its TIME-1 clinical trial, a pivotal phase III trial of the company's Hsp90 inhibitor tanespimycin as a treatment for multiple myeloma.

The TIME (Tanespimycin in Myeloma Evaluation) program includes two clinical trials. TIME-1 is a pivotal phase III trial to be conducted in a first-relapse patient population. It will evaluate the clinical benefit of adding tanespimycin to bortezomib, compared with single-agent bortezomib.

TIME-2, designed to be supportive of TIME-1, is a phase II/III trial in patients with relapsed/refractory disease. It is currently enrolling patients at sites primarily in the United States and Europe.

The TIME program is being conducted using Kosan's improved tanespimycin injectable suspension formulation, the company said. The new formulation eliminates Cremophor and the associated need for steroid premedication to prevent hypersensitivity reactions.