* BSI-201 misses main goals of Phase III study
* Survival benefit seen in second- and third-line patients
* Did not significantly add to toxicity
NEW YORK, Jan 27 An experimental drug for a
type of advanced breast cancer being developed by
Sanofi-Aventis (SASY.PA) failed to extend life or slow disease
progression in a late-stage clinical trial, the French
drugmaker said on Thursday.
The news was particularly disappointing as the drug,
BSI-201, or iniparib, did extend survival by an average of
almost five months over chemotherapy alone in an earlier
mid-stage study of women with metastatic triple-negative breast
However, an analysis of subjects in the 519-patient Phase
III study who were undergoing their second or third treatment
regimens for the disease did show an improvement in both
overall survival and progression-free survival that was
consistent with results from the earlier trial, Sanofi said.
"While this trial did not meet its primary goal, we believe
that the improvement in overall survival and progression-free
survival in patients in the second- and third-line setting are
important findings," Debasish Roychowdhury, head of
Sanofi-Aventis Oncology, said in a statement.
Also of importance, treatment with BSI-201 did not
significantly add to the toxicity of the chemotherapy drugs
that were administered along with the Sanofi medicine, the
BSI-201, a new anti-tumor agent, is also being studied
against lung cancer and other cancers.
Sanofi said it will conduct an in depth analysis of the new
data and plans to discuss the results with U.S. and European
health regulators as development of the drug for breast cancer
Triple-negative breast cancer refers to a form of the
disease in which the tumors are shown to not be over-expressing
estrogen, progesterone or the HER2 protein.
Some 15 to 20 percent of breast cancers lack
over-expression of all three proteins, and those patients often
have poorer outcomes then those with other types of breast
(Reporting by Bill Berkrot; Editing by Bernard Orr)