Washington Editor

Millennium Pharmaceuticals Inc. stopped dosing the control arm of a confirmatory Phase III trial of Velcade, a cancer drug, after an independent review committee uncovered positive data in a prespecified interim analysis.

The committee found a statistically significant improvement in time to disease progression, the primary endpoint, in patients taking Velcade compared to individuals receiving high-dose dexamethasone, a commonly used steroid. David Schenkein, vice president for clinical oncology development at Cambridge, Mass.-based Millennium, told BioWorld Today specific data are expected to be released in mid-2004 at an appropriate scientific forum.

Nevertheless, the good news gives control patients the option of ending dexamethasone treatment in favor of Velcade (bortezomib), said Schenkein, adding, "This is a very important milestone for us."

Velcade, currently indicated for multiple myeloma, was cleared for marketing in May under the FDA's accelerated approval guidelines, which required the confirmatory, randomized Phase III study. (See BioWorld Today, May 15, 2003.)

Velcade, a first-in-class proteasome inhibitor, was approved based on a 228-patient Phase II study known as the Summit trial. Data showed that Velcade increased median survival time in relapsed and refractory multiple myeloma patients to 16.4 months. Patients usually pass away six to nine months after they are diagnosed (See BioWorld Today, Dec. 6, 2002, and Jan. 23, 2003.)

Meanwhile, the confirmatory Phase III trial, referred to as the APEX trial, included patients with relapsed or refractory multiple myeloma whose disease progressed after receiving one to three previous therapies. Schenkein pointed out that the Phase III study actually included a broader population of patients who were at an earlier stage in their disease, compared to the SUMMIT patients.

APEX evaluated 670 patients at 95 sites in the U.S., Canada, Europe and Israel. The secondary endpoints, which supported the primary endpoint, included the chance of developing a serious infection, the chance of developing a new bone fracture and overall survival.

Millennium and partner Ortho Biotech Products LP, a unit of Johnson & Johnson, of New Brunswick, N.J., are studying Velcade in many other solid tumors, Schenkein said. While the company recently presented data on a non-Hodgkin's lymphoma trial at the American Society of Hematology meeting, Schenkein said it's too early to comment on which indication they will pursue.

The companies joined forces in June to market Velcade in a deal valued at close to $500 million for Millennium. Millennium received a $15 million up-front fee and will handle U.S. sales while Ortho Biotech, of Raritan, N.J., will work outside the U.S. The companies have filed for regulatory approval in Europe and expect action in mid-2004. (See BioWorld Today, July 2, 2003.)

For the third quarter ended Sept. 30, Velcade generated about $23 million in U.S. sales, and for the year (the product was launched in early June), sales have reached $30.9 million.

Millennium's stock (NASDAQ:MLNM) rose 56 cents Monday to close at $16.97.

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