DiagnosticsBSI-201 Enters Phase III In Metastatic Triple Negative Breast Cancer
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its wholly owned subsidiary, BiPar Sciences, announced the initiation of the pivotal Phase III trial for BSI-201 in combination with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC), defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2. BSI-201 is a novel investigational targeted therapy which inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.
The Phase III 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 mTNBC. A total of 420 mTNBC patients, who have received 0-2 prior therapies in the metastatic setting, will be randomized to receive GC with or without BSI-201.
The co-primary objectives of this study are to assess improvement in progression-free survival and overall survival. The secondary objectives are to assess objective response rate and safety. An estimated 60-75 sites will be distributed throughout the United States. Importantly, this trial will have a crossover provision that will ensure that all patients enrolled in the BSI-201 Phase III clinical trial have the potential opportunity to receive BSI-201 (patients randomly assigned to the control arm may receive BSI-201 upon disease progression).
The decision to commence with the Phase III study was made based on Phase II study results presented during the Plenary Session of the American Society of Clinical Oncology (ASCO) annual conference on May 31, 2009. The randomized Phase II clinical trial involved 116 women with metastatic TNBC who were randomly assigned to receive GC in combination with the investigational agent BSI-201 or GC alone.
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 (pAbout 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.
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®) 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.
About BiPar Sciences
BiPar Sciences is a biopharmaceutical organization pioneering novel tumor-selective therapies designed to address urgent unmet needs of cancer patients. In addition to BSI-201, the company also has two additional compounds in preclinical development. BiPar Sciences, located in South San Francisco, California, is a wholly owned subsidiary of sanofi-aventis.
About Sanofi Aventis
Sanofi-aventis is a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis" management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis" annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Sanofi Aventis