PARIS, Sept. 30, 2019 /PRNewswire/ -- Data
published today in the New England Journal of Medicine
showed that patients with metastatic castration-resistant prostate
cancer (mCRPC) previously treated with docetaxel and who progressed
within 12 months on an androgen receptor (AR)-targeted agent
(abiraterone or enzalutamide) experienced significantly longer
radiographic progression free survival (rPFS) with Jevtana®
(cabazitaxel) plus prednisone compared with abiraterone plus
prednisone or enzalutamide. Overall survival (OS) with
Jevtana was also significantly longer. These findings from the
CARD study were presented today in the Presidential Symposium of
the 2019 European Society of Medical Oncology (ESMO) Congress in
Barcelona, Spain.
"In this study, treatment with Jevtana significantly improved
radiographic progression free survival and overall survival
compared with enzalutamide or abiraterone," said Professor
Ronald de Wit from Erasmus MC University Hospital, Rotterdam, The Netherlands, and the lead
investigator of the CARD study. "These results
are exciting as they have the potential to impact treatment
guidelines for metastatic prostate cancer and current clinical
practice."
CARD is a randomized, open-label, treatment sequencing clinical
study involving 62 sites across 13 European countries, enrolling
255 patients (median aged 70 years, 31% aged over 75 years) with
mCRPC who were previously treated with docetaxel and who progressed
within 12 months on an AR-targeted agent, in any order. These
patients were randomized 1:1 to Jevtana (25 mg/m2
intravenously every three weeks, daily prednisone, and granulocyte
colony-stimulating factor) versus abiraterone (1,000 mg plus
prednisone, daily) or enzalutamide (160 mg daily; patients received
abiraterone if they were previously treated with enzalutamide, or
enzalutamide if they were previously treated with abiraterone).
CARD study met primary and secondary endpoints
The study's primary endpoint was rPFS, which more than doubled
with Jevtana treatment (N=129) compared to abiraterone or
enzalutamide (N=126; median 8.0 vs 3.7 months; HR=0.54; 95%
CI,0.40–0.73; p<0.0001). Patients treated with Jevtana
experienced an improvement in rPFS in all pre-specified subgroups,
irrespective of the timing of the previous alternative AR-targeted
agent, before or after docetaxel. Jevtana also significantly
improved a key secondary endpoint, OS (median 13.6 vs 11.0 months;
HR=0.64; 95%CI, 0.46–0.89; p=0.0078), reducing the risk of death
from any cause by 36% compared with abiraterone or enzalutamide.
Other key secondary endpoints all favored Jevtana: progression-free
survival (PFS) (median 4.4 vs 2.7 months; p<0.0001); confirmed
prostate specific antigen (PSA) (35.7% vs 13.5%; p=0.0002) and
tumor responses (36.5% vs 11.5%; p=0.004). Pain response (45.0% vs
19.3%; p<0.0001) and time to symptomatic skeletal events (not
reached vs 16.7 months, p=0.0499) were also significantly improved
with Jevtana treatment.
The incidence of grade ≥3 adverse events was (56.3% with
Jevtana vs 52.4% with AR-targeted agents). Key grade ≥3
treatment-emergent adverse events with Jevtana versus AR-targeted
agents were renal disorders (3.2% vs 8.1%), infections (7.9% vs
7.3%), musculoskeletal pain/discomfort (1.6% vs 5.6%), cardiac
disorders (0.8% vs 4.8%), asthenic conditions (4.0% vs 2.4%),
diarrhea (3.2% vs 0), peripheral neuropathy (3.2% vs 0) and febrile
neutropenia (3.2% vs 0). Serious adverse event rates of any grade
were similar for Jevtana treatment (38.9%) and treatment with an
AR-targeted agent (38.7%). AEs led to death in 7 vs 14 patients
(5.6% vs 11.3%) for Jevtana compared to AR-targeted agents. No new
safety signals were observed.
About Prostate Cancer
Prostate cancer is a very heterogenous disease and one of the
most common types of cancer in men.1 Prostate cancer is
the second leading cause of cancer related death among men in
the United States2 and
the third in Europe.3
Metastatic castration-resistant prostate cancer (mCRPC) is
prostate cancer that has spread beyond the prostate gland and
progressed despite androgen deprivation therapy.
About Jevtana (cabazitaxel)
Jevtana is a semi-synthetic taxane chemotherapy. Jevtana is a
microtubule inhibitor that binds to tubulin. This leads to the
stabilization of microtubules, which results in the inhibition of
mitotic and interphase cellular functions.
U.S. INDICATION
JEVTANA is a prescription anti-cancer medicine used with the
steroid medicine prednisone. JEVTANA is used to treat men with
castration-resistant prostate cancer (prostate cancer that is
resistant to medical or surgical treatments that lower
testosterone) that has worsened (progressed) after treatment with
other medicines, including docetaxel.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
What is the most important information I should know about
JEVTANA?
JEVTANA may cause serious side effects, including:
Low white blood cells, which can cause you to get
serious infections, and may lead to death. Men who are 65 years or
older may be more likely to have these problems.
Your healthcare provider (HCP):
- will do blood tests regularly to check your white blood cell
counts during your treatment with JEVTANA.
- may lower your dose of JEVTANA, change how often you receive
it, or stop JEVTANA until your HCP decides that you have enough
white blood cells.
- may prescribe a medicine for you called G-CSF, to help prevent
complications if your white blood cell count is too low.
Tell your HCP right away if you have any of these symptoms of
infection during treatment with JEVTANA: fever (take your
temperature often during treatment with JEVTANA), cough, burning
during urination, or muscle aches.
Also, tell your HCP if you have any diarrhea during the time
that your white blood cell count is low. Your HCP may prescribe
treatment for you as needed.
Severe allergic reactions can happen within a few
minutes after your infusion of JEVTANA starts, especially during
the first and second infusions. Your HCP should prescribe medicines
before each infusion to help prevent severe allergic reactions.
Tell your HCP right away if you have any of these symptoms of
a severe allergic reaction during or soon after an infusion of
JEVTANA: rash or itching, skin redness, feeling dizzy or
faint, breathing problems, chest or throat tightness, or swelling
of face.
JEVTANA can cause severe stomach and intestine problems,
which may lead to death. You may need to go to the hospital for
treatment.
Vomiting and diarrhea can happen when you receive JEVTANA.
Severe vomiting and diarrhea with JEVTANA can lead to loss of too
much body fluid (dehydration), or too much of your body salts
(electrolytes). Death has happened from having severe diarrhea and
losing too much body fluid or body salts with JEVTANA. Your HCP
will prescribe medicines to prevent or treat vomiting and diarrhea,
as needed with JEVTANA.
Tell your HCP if: you have vomiting or diarrhea, or
if your symptoms get worse or do not get better. JEVTANA can cause
a leak in the stomach or intestine, intestinal blockage, infection,
and bleeding in the stomach or intestine. This can lead to
death. Tell your HCP if you get any of these
symptoms: severe stomach-area (abdomen) pain,
constipation, fever, blood in your stool, or changes in the color
of your stool.
Kidney failure may happen with JEVTANA, because of
severe infection, loss of too much body fluid (dehydration), and
other reasons, which may lead to death. Your HCP will check you for
this problem and treat you if needed.
Tell your HCP if you develop these signs or
symptoms: swelling of your face or body, or decrease in
the amount of urine that your body makes each day or blood in your
urine.
Lung or breathing problems may happen with JEVTANA
and may lead to death. Men who have lung disease before receiving
JEVTANA may have a higher risk for developing lung or breathing
problems with JEVTANA treatment. Your HCP will check you for this
problem and treat you if needed.
Tell your HCP right away if you develop any new or worsening
symptoms, including: trouble breathing, shortness of breath, chest
pain, cough or fever.
Who should not receive JEVTANA?
Do not receive JEVTANA if: your white blood cell
(neutrophil count) is too low, you have had a severe allergic
reaction to cabazitaxel or other medicines that contain polysorbate
80 (ask your HCP if you are not sure), you have severe liver
problems or you are pregnant. JEVTANA can harm your unborn baby or
possibly cause loss of pregnancy.
What should I tell my HCP before receiving
JEVTANA?
Before receiving JEVTANA, tell your HCP if
you:
- had allergic reactions in the past
- are age 65 or older
- have kidney or liver problems
- have lung problems
- are a male with a female partner who is able to become
pregnant. Males should use effective birth control (contraception)
during treatment with JEVTANA and for 3 months after your final
dose of JEVTANA.
JEVTANA may cause fertility problems in males. This may affect
your ability to father a child. Talk to your HCP if you have
concerns about fertility.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. JEVTANA can interact with many other medicines. Do not
take any new medicines without asking your HCP first. Your HCP will
tell you if it is safe to take the new medicine with JEVTANA.
What are the possible side effects of JEVTANA?
Common side effects of JEVTANA include:
- Low red blood cell count (anemia), which is common with
JEVTANA, but can sometimes also be serious. Your HCP will regularly
check your red blood cell count. Symptoms of anemia include
shortness of breath and tiredness.
- Low blood platelet count, which is common with JEVTANA, but can
sometimes also be serious. Tell your HCP if you have any unusual
bruising or bleeding.
- Inflammation of the bladder, which has happened in men who have
previously received pelvic radiation therapy. Tell your HCP if you
have blood in your urine, burning sensation during urination, or
frequent or urgent need to urinate.
- fever
- diarrhea
- tiredness
- nausea
- vomiting
- constipation
- weakness
- back pain
- numbness, tingling, burning or decreased sensation in your
hands or feet
- shortness of breath
- stomach pain
- change in your sense of taste
- cough
- joint pain
- hair loss
- decreased appetite
Tell your HCP if you have any side effect that bothers you or
that does not go away. These are not all the possible side
effects of JEVTANA. For more information, ask your HCP or
pharmacist.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing
Information / Patient Information, including Serious Side
Effects.
About Sanofi
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challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
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With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
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1https://www.who.int/en/news-room/fact-sheets/detail/cancer
2Siegel RL, Miller KD, Jemal
A. Cancer statistics, 2019. CA Cancer J Clin.
2019;69(1):7-34.
3Malvezzi M, Carioli G, Bertuccio P, et al. European
cancer mortality predictions for the year 2019 with focus on breast
cancer. Ann Oncol. 2019;30(5):781-787
SAUS.CAB.19.09.4971
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