Cabazitaxel Increased Survival for Patients with Advanced Hormone-Refractory Prostate Cancer
- Results observed in patients treated with cabazitaxel plus prednisone whose disease progressed despite prior docetaxel-based chemotherapy - - Data from large international Phase 3 study to be presented at the 2010 Genitourinary Cancers Symposium in San Francisco -
BRIDGEWATER, N.J., March 3 /PRNewswire-FirstCall/ --
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today
results from a Phase 3 trial which demonstrated cabazitaxel, an
investigational compound, plus prednisone/prednisolone
significantly improved overall survival and progression-free
survival in patients with metastatic (advanced) hormone-refractory
prostate cancer whose disease progressed following treatment with
docetaxel-based chemotherapy. The TROPIC trial compared the
combination of cabazitaxel plus prednisone/prednisolone to the
active agent mitoxantrone plus prednisone/prednisolone.
For many patients with metastatic hormone-refractory prostate
cancer, their disease continues to progress despite prior
chemotherapy. Currently, there are no approved therapies to treat
these patients.
"These are significant results in the development of this
investigational drug," said Dr. Oliver Sartor, North American
principal investigator, Piltz Professor for Cancer Research at
Tulane Medical School, New Orleans. "Improved overall survival was
demonstrated in this trial - and these are the first data to show a
statistical improvement in overall survival in patients with this
difficult-to-treat and aggressive form of prostate cancer."
TROPIC was designed to assess patients with metastatic
hormone-refractory prostate cancer whose disease had progressed
following treatment with docetaxel-based chemotherapy. Results
showed that the combination of cabazitaxel and
prednisone/prednisolone significantly reduced the risk of death by
30% [HR=0.70 (95% CI: 0.59-0.83); P<0.0001] with a clinically
meaningful improvement in the median overall survival of 15.1
months in the cabazitaxel combination arm vs. 12.7 months in the
mitoxantrone combination arm. Patients who received the combination
treatment with cabazitaxel also experienced a significant increase
in median progression-free survival (2.8 months vs. 1.4 months)
[HR=0.74 (95% CI: 0.64 - 0.86); P<0.0001)].
The most frequent grade 3/4 hematological adverse events with
cabazitaxel included neutropenia (81.7%), febrile neutropenia
(7.5%) and infections (10.2%); the most frequent grade 3/4
non-hematological adverse events included nausea (1.9%), vomiting
(1.9%) and diarrhea (6.2%). Most frequent treatment-emergent
adverse events leading to discontinuation in the cabazitaxel arm
were neutropenia (2.4%), hematuria (1.3%), diarrhea (1.1%) and
fatigue (1.1%). Grade 3/4 peripheral neuropathy occurred in 0.5% of
patients in the cabazitaxel arm vs. 0.3% in the mitoxantrone arm.
Deaths due to adverse events were 4.9% in the cabazitaxel arm
(predominantly due to neutropenia and its complications) vs. 1.9%
in the mitoxantrone arm.
"These are compelling results which we are looking forward to
sharing with the health care and oncology community," said Debasish
Roychowdhury, M.D., Senior Vice President, Global Oncology,
sanofi-aventis. "Providing new options and hope for patients with
serious diseases, such as metastatic hormone-refractory prostate
cancer, is what drives our ongoing commitment to researching and
exploring novel anti-cancer compounds and to bringing these
medicines to patients."
Results will be presented by Dr. Sartor in San Francisco, CA on
March 5 at the 2010 Genitourinary Cancers Symposium sponsored by
the American Society for Clinical Oncology (ASCO), the American
Society for Radiation Oncology (ASTRO) and the Society of Urologic
Oncology (SUO).
About the TROPIC Trial
TROPIC was conducted in 146 trial sites in 26 countries
throughout the world, including the U.S. The multi-center Phase 3
randomized registrational trial assessed 755 metastatic
hormone-refractory prostate cancer patients whose disease had
progressed despite previous docetaxel-based chemotherapy.
The primary endpoint was overall survival. Secondary endpoints
included progression-free survival, tumor response rate, tumor
progression, prostate-specific antigen (PSA) response, PSA
progression, pain response, and pain progression. Disease
progression in this trial was defined as tumor progression, PSA
progression or pain progression. Patients were randomly assigned to
receive cabazitaxel plus prednisone/prednisolone or mitoxantrone
plus prednisone/prednisolone (378 and 377 patients, respectively).
Patients were to receive either regimen for up to a maximum of 10
cycles.
About Cabazitaxel
Cabazitaxel is a novel investigational taxane compound that may
be active in cell lines refractory to taxanes. Cabazitaxel has been
shown to inhibit cell division and tumor cell proliferation by
binding to and stabilizing tubulin, a protein in the microtubules
of cells which provides a skeleton for maintaining cell
shape.
Cabazitaxel recently received fast track designation from the
U.S. Food and Drug Administration (FDA) - a process designed to
expedite the review of drugs being developed for serious diseases
with the potential to address an unmet medical need. The rolling
submission has already started and allows for completed sections of
a New Drug Application to be submitted on an ongoing basis.
About Prostate Cancer
Worldwide, prostate cancer ranks third in cancer incidence and
sixth in cancer mortality in men. In the U.S., prostate cancer
remains the second most common cause of cancer death among men
after lung cancer. In 2009, an estimated 192,000 new cases were
anticipated in the U.S., while 27,000 men were expected to have
died from the disease.
Metastatic prostate cancer indicates that the cancer has spread,
or metastasized, to the lymph nodes or other parts of the body,
mostly to the bones; castration resistant/hormone-refractory
prostate cancer means that the cancer has continued to grow despite
the suppression of male hormones that fuel the growth of prostate
cancer cells. More than 80% of all prostate cancer cases are
discovered when the disease is limited to the prostate and
surrounding organs, while 10-20% of patients are diagnosed when the
cancer has already metastasized.
About sanofi-aventis
Sanofi-aventis U.S. is an affiliate of sanofi-aventis, 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) . For more information, visit:
www.sanofi-aventis.us or www.sanofi-aventis.com
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Contact: -------- Madeline Malia Tel: (908) 981-5687 E-mail: madeline.malia@sanofi-aventis.com US.ONP.10.02.003
Source: sanofi-aventis
CONTACT: Madeline Malia, +1-908-981-5687,
madeline.malia@sanofi-aventis.com
Web Site: http://www.sanofi-aventis.us/
http://www.sanofi-aventis.com/
Posted: March 2010
