Millennium’s Velcade, As Time Wears On, Shows Durable Ability to Prolong Lives

12/8/08Follow @xconomy

Millennium Pharmaceuticals may not be the breakout performer at this year’s American Society of Hematology (ASH) meeting like it was a year ago, but another 12 months of follow-up data is strengthening the case that its cancer drug is no fluke.

Cambridge, MA-based Millennium, now a unit of Japan’s Takeda Pharmaceuticals, presented follow-up data today at the ASH conference in San Francisco, the largest annual meeting of specialists in blood cancers and other blood diseases. The results show bortezomib (Velcade) is able to extend lives for patients getting their initial round of therapy for multiple myeloma, a deadly cancer of the bone marrow. One study of 680 patients found that after more than two years of follow-up (25.9 months), patients had a 36 percent lower risk of death if they took a regimen with bortezomib than if they didn’t get the drug.

This data buttresses findings that Millennium released at last year’s ASH, when I saw a standing-room only crowd of physicians in Atlanta give the company a roaring standing ovation for the results it delivered for patients newly diagnosed with multiple myeloma. The drug, in combination with two immune suppressors, showed it was able to cause 35 percent of people newly diagnosed with multiple myeloma to go into complete remission. That was compared to just 5 percent who did that well on the immune suppressors alone. The trial of 680 patients, called Vista, cleared the way for Millennium to get expanded FDA clearance to market the drug to patients getting their first round of treatment, in addition to relapsers. It also no doubt helped propel it to blockbuster status this year with more than $1 billion in sales.

“Last year was an incredible landmark year for us in the first-line setting, and this year we are showing the important long-term effects,” says Nancy Simonian, Millennium’s chief medical officer.

Multiple myeloma may not be a household name, but the disease is fairly common as cancers go. About 20,000 cases are diagnosed each year in the U.S., and more than 10,000 people die from it, according to the American Cancer Society. That’s roughly on par with stomach cancer, and skin cancer.

One catch with all cancer drugs is that complete remissions can be a reliable predictor of a drug that helps extend lives, or they can be fleeting, as tumors bounce right back and kill people. So the follow-up data is important. This question will take years to answer, because patients with this prognosis currently can expect to live five to six years, so it will take more time to see if patients who got the Millennium product really do end up living longer than those on standard treatment, Simonian says.

Two studies suggested that the Millennium product is working over the long haul, although the findings still aren’t the final word. One study called IFM found that after two years 69 percent of patients still had no sign of their cancer spreading through the body after taking a bortezomib with dexamethasone, an immune suppressor. That’s compared with 60 percent who had that status on a chemotherapy regimen that included vincristine, adriamycin, and dexamethasone, Simonian says. The difference was statistically significant.

Another trial of 460 patients, known as Gimema, found that 90 percent of patients on the Millennium drug in combination with thalidomide and dexamethasone still hadn’t seen their disease worsen, compared with 80 percent who did that well on the latter two drugs alone. After 15 months, 96 percent of patients on the bortezomib combination were alive in this study, compared with 91 percent in the control group. The statistical curves are starting to show a difference.

Now that survival data is starting to roll in, researchers are already thinking about how to do even better. One early-stage trial, presented over the weekend, showed some promising results of a four-drug combination regimen that contained bortezomib, a steroid immune suppressor, a type of chemotherapy known as an alkylating agent, and lenalidomide. The last drug is marketed by Summit, NJ-based Celgene (NASDAQ: CELG), Millennium’s chief competitor, which sells its product under the name Revlimid.

The data from 25 patients found that all of them were graded as having at least partial tumor shrinkage, while 36 percent had their tumors completely go away. Piling four drugs on top of one another also caused a lot of serious side effects. About 40 percent had serious side effects, with constipation, fatigue, and nausea among the most common, Millennium said in a statement.

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