OncologyInvestigational Cancer Drug BSI-201 Showed Clinical Benefit In 62% Of Patients With Triple-Negative Metastatic Breast Cancer
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its fully
owned subsidiary, BiPar Sciences, today announced results from a randomized
Phase 2 clinical trial of BSI-201, a poly ADP-ribose polymerase (PARP)
inhibitor, in combination with gemcitabine and carboplatin (GC) chemotherapy,
in patients with metastatic triple-negative breast cancer (TNBC). BSI-201 is
a novel investigational agent that acts by inhibiting PARP1, an enzyme that
repairs DNA damage.
In this study, 116 women with metastatic TNBC, defined as
tumors lacking expression of estrogen and progesterone receptors and without
overexpression of HER2, were randomly assigned to receive GC in combination
with the investigational agent BSI-201 or GC alone. Patients assigned to
receive chemotherapy without BSI-201 were allowed to receive BSI-201 at the
time of disease progression.
The primary study endpoint was the rate of clinical benefit,
defined as complete or partial response or stable disease of at least 6
months. Secondary study endpoints included progression-free survival, overall
survival and safety.
Approximately 62 percent of patients receiving BSI-201 in
combination with GC showed clinical benefit, compared with 21 percent in the
group receiving chemotherapy alone (p= 0.0002). Tumor response (complete or
partial response) was observed in 48 percent of patients who received BSI-201
combined with chemotherapy, whereas patients receiving chemotherapy alone
showed a response rate of 16 percent. Women who received BSI-201 had a median
progression-free survival of 6.9 months and overall survival of 9.2 months
compared with 3.3 and 5.7 months, respectively, for women who received
chemotherapy alone. The hazard ratios for progression free survival and
overall survival were 0.342 (p About BSI-201
Among other investigational PARP inhibitors in the industry,
BSI-201 is the furthest along in clinical development in metastatic TNBC.
BSI-201 is currently being evaluated for its potential to enhance the effect
of chemotherapy-induced DNA damage. The clinical development of BSI-201 is
supported by well documented safety profile based on studies of more than 200
patients.
About TNBC
When patients are diagnosed with breast cancer, their tumors
are routinely tested for the presence of estrogen and progesterone receptors
and for the over-expression of HER2. Commonly used breast cancer therapies
target these receptors; for example, tamoxifen for estrogen receptor and
trastuzumab (Herceptin(r)) for HER2. However, 15-20% of all breast cancers
lack over-expression of all three proteins, thus giving rise to the term
"triple- negative breast cancer" or "TNBC."
TNBC can be an aggressive disease, with higher rates of
metastases and poorer survival rates than other breast cancer subtypes. No
treatment has been approved specifically for TNBC.
Sanofi-aventis