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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.