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Microsoft word - iniparib ph ii nejm 050111 eng.docSanofi-aventis Press Release
Positive Phase II Results with BSI-201 (Iniparib) in Women with Metastatic Triple Negative Breast Cancer Published in The New England Journal of Medicine
Paris, France – January 5, 2011 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its wholly
owned subsidiary, BiPar Sciences, today announced that The New England Journal of Medicine (NEJM)
published the final Phase II data for the investigational drug BSI-201 (iniparib*) demonstrating significant
clinical benefit in women with metastatic triple negative breast cancer (mTNBC) when BSI-201 (iniparib)
was administered in combination with chemotherapy agents gemcitabine/carboplatin. Although not a pre-
specified endpoint, overall survival also was significantly increased in women who received BSI-201
The study, "Iniparib plus Chemotherapy in Metastatic Triple-Negative Breast Cancer," was published in the
January 5, 2011 online version of The New England Journal of Medicine and will be published in the
January 20, 2011 print edition. These findings were presented at the 35th European Society for Medical
Oncology (ESMO) Congress in Milan, Italy.
“These published data show that the addition of iniparib to gemcitabine and carboplatin provided a
significant improvement in clinical benefit in women with metastatic triple negative breast cancer, an
aggressive form of breast cancer with no approved standard treatments that target this particular tumor
subtype,” said Joyce O’Shaughnessy, M.D., lead investigator of the study and co-chair of the Breast
Cancer Research Program at the Baylor-Charles A. Sammons Cancer Center, Texas Oncology, U.S.
Oncology in Dallas.
According to the study results, 56 percent of patients in the BSI-201 (iniparib) group showed a clinical
benefit – defined as a complete or partial response or stable disease of at least six months – compared
with 34 percent (p=0.01) of patients in the chemotherapy group alone. Median progression-free survival in
the BSI-201 (iniparib) group was 5.9 months compared with 3.6 months in the chemotherapy group (95%
CI (0.39-0.90) HR=0.59, p=0.01). The overall response rate was 52 percent in the BSI-201 (iniparib) group
versus 32 percent (p=0.02) in the chemotherapy group alone. Although it was not a pre-specified endpoint
of the trial median overall survival among women who received BSI-201 (iniparib) was 12.3 months,
compared with 7.7 months among women who received chemotherapy alone – translating to a 43 percent
reduction in the risk of death (95% CI, (0.36-0.90) HR=0.57, p=0.01).
In the phase II BSI-201 (iniparib) study, the most common any grade adverse events in the BSI-201
(iniparib) arm were neutropenia, anemia, thrombocytopenia, fatigue/asthenia, nausea and constipation.
The most common grade 3/4 adverse events in the BSI-201 (iniparib) treatment arm were neutropenia,
anemia, thrombocytopenia, leukopenia and fatigue/asthenia. There were two fatal adverse events (3.4%) in
the chemotherapy-alone group and three (5.3%) in the BSI-201 (iniparib) group, all attributed to disease
progression within 30 days of receiving study treatment. A large phase III study is ongoing and results are
expected in 2011.
* Iniparib is the United States Adopted Name (USAN) for the investigational agent BSI-201.
Media Relations: Tél. : (+) 33 1 53 77 44 50 - E-mail : MR@sanofi-aventis.com
Investor Relations : Tél. : (+) 33 1 53 77 45 45 - E-mail : IR@sanofi-aventis.com
About the Phase II BSI-201 (Iniparib) Study
This multicenter, open-label, randomized study included 123 women with mTNBC. The primary endpoints
were safety and tolerability and clinical benefit rate of BSI-201 (iniparib), defined as a complete or partial
response or stable disease of at least six months. Secondary endpoints included overall response rate and
progression-free survival. Overall survival was also assessed, although it was not a pre-specified endpoint
of the trial. Patients received gemcitabine and carboplatin alone (chemotherapy group) or in combination
with BSI-201 (iniparib) until disease progression or unacceptable toxicity. Patients in the chemotherapy
group whose disease progressed were allowed to cross over to the BSI-201 (iniparib) plus chemotherapy
group. Efficacy analyses were conducted on the intent-to-treat (ITT) population.
About BSI-201 (Iniparib)
BSI-201 (iniparib) is a novel investigational anti-tumour agent with poly (ADP-ribose) polymerase (PARP)
BSI-201 (iniparib) is in phase III trials for patients with mTNBC and squamous non-small cell lung cancer,
as well as in phase II trials for patients with ovarian, uterine and brain cancers.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation to iniparib for mTNBC. The
regulatory submissions are planned for Q1 2011 in the United States and Q2 2011 in the European Union.
About Triple-Negative Breast Cancer (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. However, 15 to 20 percent of
all breast cancers lack over-expression of all three proteins – giving rise to the term “triple negative breast
cancer” or TNBC. Research has shown TNBC can be difficult to treat, leading the disease to be associated
with poorer outcomes than other types of breast cancer. Women with TNBC are not candidates for
hormonal therapy such as tamoxifen or the targeted therapy Herceptin, leaving chemotherapy as the
About sanofi-aventis Oncology
Sanofi-aventis Oncology is targeting cancer on all fronts in an effort to address unmet medical needs for a
broad range of patients. Starting with a deep understanding of the mechanisms by which cancer develops,
grows and spreads, as well as identifying the right science early in the discovery process, the company
employs innovative approaches to bring the right medicines to the right patients. There are currently more
than 10 compounds in development across a broad scientific platform, including cytotoxic, antimitotic, anti-
angiogenic agents, antivascular agents, monoclonal antibodies and cancer vaccines, as well as supportive
care therapies. Four of these compounds are now being investigated in Phase III clinical studies aimed at
multiple solid and hematologic tumors.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic
solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New
York (NYSE: SNY). For more information, please visit www.sanofi-aventis.com.
About BiPar Sciences
BiPar Sciences is a biopharmaceutical organization dedicated to pioneering novel tumor-selective
therapies designed to address urgent unmet needs of cancer patients. Located in South San Francisco,
California, BiPar is a wholly owned subsidiary of sanofi-aventis. For more information, please visit
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1995, as amended. Forward-looking statements are statements that are not historical facts. These statements
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authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological
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well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including
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Oncology Division Communications
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