Triple negative breast cancer drug BSI-201 may get speedier review in US : Sanofi Aventis

A drug to treat triple negative braest cancer BSI-201 may get a faster review in US.

BSI-201 is a poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair inhibitor.

BSI-201 entered a Phase 3 clinical trial in the United States in July 2009 and is being evaluated in combination with chemotherapy in patients with metastatic triple-negative breast cancer, a condition defined by tumors lacking expression of estrogen, progesterone receptors and without over expression of HER2.

Study investigators have enrolled 214 of the target number of 420 patients.

The Phase 3 trial is a multi-center, randomized trial designed to evaluate the safety and efficacy of BSI-201 when combined with gemcitabine and carboplatin (GC) in women with metastatic triple-negative breast cancer.

The co-primary objectives of the Phase 3 study are to assess improvement in progression-free survival and overall survival. The secondary objectives are to assess objective response rate and safety. The trial encompasses an estimated 94 sites in the United States. Importantly, this trial will have a crossover provision that will ensure that all patients enrolled in the BSI-201 Phase 3 clinical trial have the potential opportunity to receive BSI-201, patients randomly assigned to the control arm may receive BSI-201 upon disease progression.

In the Phase 2 clinical trial, women with metastatic triple-negative breast cancer
who were randomly assigned to receive gemcitabine and carboplatin (GC) in combination with the investigational agent BSI-201 or GC alone.

Phase 2 data – including overall survival – were presented at a poster session at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS).

The addition of BSI-201 to gemcitabine and carboplatin (GC) improved median overall survival from 7.7 months to 12.2 months.

BSI-201 did not add to the frequency or severity of adverse events associated with chemotherapy.

BSI_201 Phase 2 data has also updated analysis of overall survival. Median survival has not yet been reached in the BSI-201 arm, therefore the data cut-off period for the Phase 2 trial from September to November.

“The updated analysis from the Phase 2 program, including data on overall survival, are consistent with the positive results presented earlier this year at ASCO,” stated Marc Cluzel, Executive Vice President, R&D, sanofi-aventis.

BSI-201 is currently being evaluated for its potential to enhance the effect of chemotherapy-induced DNA damage on cancer cells where PARP hyperactivity was demonstrated.

BSI-201 is in Phase 3 formetastatic triple-negative breast cancer, as well as in Phase 2 trials in patients with ovarian, uterine, brain and lung cancers.

What is triple-Negative Breast Cancer?

Breast cancer patients 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 for HER2.

However, 15-20 percent 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.

Located in South San Francisco, California, BiPar Sciences is a biopharmaceutical organization. In addition to BSI-201, the company also has two additional compounds in preclinical development. BiPar Sciences is an independent, wholly owned subsidiary of sanofi-aventis, Inc.

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutics.