Takeda drug cuts myeloma death risk in 5-year study

Mon Dec 12, 2011 1:56pm EST

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(Reuters) - Takeda Pharmaceutical Co's Velcade reduced the risk of death by 31 percent when used in combination with standard medicines in previously untreated multiple myeloma patients, according to five-year follow-up data from a late stage clinical trial.

The survival benefit in patients who received Velcade, known chemically as bortezomib, was observed in all analyzed subgroups, including those older than 75, patients with impaired kidney function and those with a more advanced stage of disease, researchers said.

Takeda had previously reported that after five years of follow-up patients who received Velcade plus the chemotherapy drug melphalan and the steroid prednisone on average lived 13.3 months longer than those who got only melphalan and prednisone

-- 56.4 months vs 43.1 months. The U.S. Food and Drug Administration allowed Takeda to add that survival benefit to Velcade's label last month.

"The overall survival data is impressive," said Dr. Jesus San Miguel, the study's primary investigator.

Detailed data from the study was presented on Monday at the American Society of Hematology meeting in San Diego. Those in the 682-patient trial had been treated for 54 weeks and were then observed for an average of five years to yield the new data.

"This combination of bortezomib, melphalan and prednisone indicates that it is a clear standard of care for treatment of myeloma patients," San Miguel said, careful to add that it would not be the only standard of care.

Among the findings presented, Velcade significantly delayed the time to next treatment -- 27 months vs 19.2 months -- and doubled the median treatment free interval compared with those who did not get the Takeda drug -- 16.6 months vs 8.3 months.

Among patients who needed subsequent therapies, overall survival was significantly longer in those who were initially given Velcade as part of their treatment regimen -- 55.7 months vs 46.4 months, researchers said.

"There is a clearly a significant benefit for using bortezomib, melphalan and prednisone up front," San Miguel said.

Researchers also found no evidence that the Velcade combination as an initial treatment induced more drug resistant

relapses, and there was no issue with second primary cancers.

"This is very important since myeloma patients are living longer they have more risk of second primary malignancies," San Miguel explained. "There is not any sign of an increase in second primary malignancies."

Velcade was developed by Millennium Pharmaceuticals, which was acquired by the Japanese drugmaker and now serves as Takeda's oncology unit. The survival benefit seen in this study is likely to help boost annual sales of the drug, which approached $600 million in the United States for Takeda for the most recent fiscal year. Johnson & Johnson records Velcade sales outside the United States.

"If you put together this benefit plus the new knowledge of how to reduce the side effects, I'm sure that doctors will feel much more comfortable using this combination in the coming days," said San Miguel, noting that weekly Velcade dosing has led to fewer and less serious side effects than twice weekly.

About 20,500 Americans will be diagnosed with multiple myeloma in 2011 and 10,600 will die from the disease, according to American Cancer Society estimates.

(Reporting by Bill Berkrot, editing by Dave Zimmerman)

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