Metastatic Prostate Cancer

Results of LYNPARZA

Learn how LYNPARZA was studied in clinical trials.

LYNPARZA is a targeted treatment for certain patients with metastatic castration-resistant prostate cancer (mCRPC). Learn about the 2 different ways that LYNPARZA was studied and ask your doctor if you have questions about the results of these clinical trials.

Not a real patient.

LYNPARZA IN COMBINATION WITH ABIRATERONE & PREDNISONE OR PREDNISOLONE AS INITIAL TREATMENT FOR mCRPC TUMORS WITH A BRCA MUTATION

FOR ADULTS WITH A BRCA MUTATION AND mCRPC

LYNPARZA in combination* may give you more time without your cancer getting worse

The results below are from a smaller group (or subset) of patients in a larger study that tested a total of 796 patients. These 796 patients had metastatic castration-resistant prostate cancer (mCRPC).^† The subset consisted of 85 patients with a BRCA mutation. 47 patients took LYNPARZA 300 mg twice daily in combination with abiraterone 1000 mg daily and prednisone or prednisolone, and 38 took abiraterone and prednisone or prednisolone alone.

IN PATIENTS WITH A BRCA MUTATION

76%

LYNPARZA in combination* lowered the risk of cancer progressing or death by 76% compared to abiraterone and prednisone or prednisolone alone

33 out of 47 adults with a BRCA mutation did not have disease progression or death with LYNPARZA in combination* compared with 10 out of 38 adults treated with abiraterone and prednisone or prednisolone alone.

Based on the design of this study, the statistical meaning of these results may be limited. Talk to your doctor to see if LYNPARZA in combination with abiraterone and prednisone or prednisolone is right for you.

*Combination therapy: LYNPARZA with abiraterone and prednisone or prednisolone.

^†Patients in this clinical trial were required to receive gonadotropin-releasing hormone (GnRH) analog therapy or have had a surgery to lower the amount of testosterone in their body (surgical castration).

LYNPARZA ALONE FOR mCRPC TUMORS WITH AN HRR MUTATION AFTER PROGRESSION ON ENZALUTAMIDE OR ABIRATERONE

FOR ADULTS WITH BRCA1, BRCA2, OR ATM MUTATIONS AND mCRPC

LYNPARZA used alone may give you more time without your cancer getting worse

The results below are from a smaller group (or subset) of patients in a larger study that tested a total of 387 patients.* These 387 patients had 1 or more of 15^† HRR genetic tumor mutations and metastatic castration-resistant prostate cancer (mCRPC) after they were no longer responding to hormone therapies enzalutamide or abiraterone. The subset consisted of 245 patients with BRCA1, BRCA2, or ATM gene mutations. 162 patients took LYNPARZA 300 mg twice daily and 83 took hormone therapies enzalutamide or abiraterone.

IN PATIENTS WITH BRCA1, BRCA2, OR ATM MUTATIONS

66%

LYNPARZA lowered the risk of cancer progressing or death by 66% compared to treatment with hormone therapies enzalutamide or abiraterone

56 out of 162 adults with a BRCA1, BRCA2, or ATM mutation did not have disease progression or death with LYNPARZA compared with 15 out of 83 adults on enzalutamide or abiraterone.

LYNPARZA more than doubled the median time without cancer progressing or death compared with treatment with hormone therapies enzalutamide or abiraterone

MEDIAN TIME ON LYNPARZA

7.4 months

MEDIAN TIME ON ENZALUTAMIDE OR ABIRATERONE

3.6 months

*Patients in this clinical trial were required to receive GnRH analog therapy or have had a surgery to lower the amount of testosterone in their body (surgical castration).

^†In addition to BRCA1, BRCA2, and ATM, other HRR genes included BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L. No patients were included who had mutations in 2 of the 15 pre-specified HRR genes: FANCL and RAD51C. Although patients with mutations in PPP2R2A were studied, LYNPARZA is not indicated for the treatment of patients with this gene mutation.

FOR ADULTS WITH BRCA1, BRCA2, OR ATM MUTATIONS AND mCRPC

LYNPARZA may help patients live longer compared with enzalutamide or abiraterone

31%

LYNPARZA lowered the risk of death by 31% compared with treatment with hormone therapies enzalutamide or abiraterone

These data are a secondary conclusion, or result, of the overall study.

In this subset, 71 out of 162 patients treated with LYNPARZA were alive at the time of follow-up compared with 26 out of 83 treated with enzalutamide or abiraterone.

The median time of survival after the start of LYNPARZA was 19.1 months vs 14.7 months on enzalutamide or abiraterone.

FOR ADULTS WITH BRCA1, BRCA2, OR ATM MUTATIONS AND mCRPC

More patients on LYNPARZA (33%) saw their tumors shrink vs patients on enzalutamide or abiraterone (2%)

PERCENTAGE OF PATIENTS ON LYNPARZA

33%

PERCENTAGE OF PATIENTS ON ENZALUTAMIDE OR ABIRATERONE

These data are a secondary conclusion, or result, of the overall study, and are based on 127 patients. 28 out of 84 patients responded to LYNPARZA vs 1 out of 43 on enzalutamide or abiraterone.

FOR ADULTS WITH A VARIETY OF SELECT HRR GENE MUTATIONS*—NOT JUST BRCA1, BRCA2, OR ATM.
LYNPARZA may increase the time without your cancer getting worse

The data below are a secondary conclusion, or result, of the overall study, which tested a total of 387 patients who had 1 or more of the 15* HRR genetic tumor mutations and metastatic castration-resistant prostate cancer (mCRPC) after they were no longer responding to hormone therapies enzalutamide or abiraterone. 256 men took LYNPARZA 300 mg twice daily and 131 took hormone therapies enzalutamide or abiraterone.

LYNPARZA increased the median time without cancer progressing or death compared with treatment with hormone therapies enzalutamide or abiraterone

MEDIAN TIME ON LYNPARZA

5.8 months

MEDIAN TIME ON ENZALUTAMIDE OR ABIRATERONE

3.5 months

76 out of 256 patients did not have disease progression or death with LYNPARZA vs 32 out of 131 patients on enzalutamide or abiraterone.

*In addition to BRCA1, BRCA2, and ATM, other HRR genes included BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L. No patients were included who had mutations in 2 of the 15 pre-specified HRR genes: FANCL and RAD51C. Although patients with mutations in PPP2R2A were studied, LYNPARZA is not indicated for the treatment of patients with this gene mutation.

WHAT IS LYNPARZA?

LYNPARZA is a prescription medicine used to treat adults who have:

advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

IMPORTANT SAFETY INFORMATION

LYNPARZA may cause serious side effects, including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.

Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.

Your healthcare provider will do blood tests to check your blood cell counts:

WHAT IS LYNPARZA?

LYNPARZA is a prescription medicine used to treat adults who have:

advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with a certain type of inherited (germline) abnormal BRCA gene. LYNPARZA is given after surgery (treatment after surgery is called adjuvant therapy). You should have received chemotherapy medicines before or after surgery to remove the tumor. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
prostate cancer with a certain type of abnormal inherited or acquired BRCA gene that has spread to other parts of the body (metastatic) and no longer responds to a medical or surgical treatment that lowers testosterone. LYNPARZA is used in combination with another anti-cancer medicine, abiraterone, together with the steroid medicine, prednisone or prednisolone. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

It is not known if LYNPARZA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Your healthcare provider will do blood tests to check your blood cell counts:

before treatment with LYNPARZA
every month during treatment with LYNPARZA
weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve

Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.

Blood clots (venous thromboembolism). Some people may develop a blood clot in a deep vein, usually in the leg (venous thrombosis) or a clot in the lungs (pulmonary embolism), which may be severe or lead to death. Tell your healthcare provider right away if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). Your healthcare provider will monitor you for these symptoms and may prescribe blood thinner medicine.

Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions, including if you:

have lung or breathing problems
have kidney problems
are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage)
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you might be pregnant following treatment with LYNPARZA
- Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA
- Do not donate sperm during treatment with LYNPARZA and for 3 months after your last dose
are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.

How should I take LYNPARZA?

Take LYNPARZA tablets exactly as your healthcare provider tells you
Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
Your healthcare provider will decide how long you stay on treatment
Take LYNPARZA by mouth 2 times a day with or without food
Each dose should be taken about 12 hours apart
Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets
If you are taking LYNPARZA for early breast cancer and you have hormone receptor-positive disease, you should continue to take hormonal therapy during your treatment with LYNPARZA
If you are taking LYNPARZA for prostate cancer and you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with LYNPARZA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration)
If you miss a dose of LYNPARZA, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose
If you take too much LYNPARZA, call your healthcare provider or go to the nearest hospital emergency room right away

What should I avoid while taking LYNPARZA?

Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood.

LYNPARZA may cause serious side effects (see above). The most common side effects of LYNPARZA when used alone are:

nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
tiredness or weakness
low red blood cell counts
diarrhea
loss of appetite
headache
changes in the way food tastes
cough
low white blood cell counts
shortness of breath
dizziness
indigestion or heartburn
low platelet counts

The most common side effects of LYNPARZA when used in combination with bevacizumab are:

nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
tiredness or weakness
low red blood cell counts
low white blood cell counts
diarrhea
urinary tract infection
headache

The most common side effects of LYNPARZA when used in combination with abiraterone are:

low red blood cell counts
tiredness or weakness
nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
diarrhea
loss of appetite
low white blood cell counts
dizziness
abdominal pain

These are not all the possible side effects of LYNPARZA. Call your healthcare provider for medical advice about side effects. You may report side effects related to AstraZeneca products (Opens in new window).

Please see complete Prescribing InformationLink opens PDF in a new tab, including Medication GuideLink opens PDF in a new tab.

WHAT IS LYNPARZA?

LYNPARZA is a prescription medicine used to treat adults who have:

advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with a certain type of inherited (germline) abnormal BRCA gene. LYNPARZA is given after surgery (treatment after surgery is called adjuvant therapy). You should have received chemotherapy medicines before or after surgery to remove the tumor. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
prostate cancer with a certain type of abnormal inherited or acquired BRCA gene that has spread to other parts of the body (metastatic) and no longer responds to a medical or surgical treatment that lowers testosterone. LYNPARZA is used in combination with another anti-cancer medicine, abiraterone, together with the steroid medicine, prednisone or prednisolone. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

It is not known if LYNPARZA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Your healthcare provider will do blood tests to check your blood cell counts:

before treatment with LYNPARZA
every month during treatment with LYNPARZA
weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve

Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions, including if you:

have lung or breathing problems
have kidney problems
are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage)
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you might be pregnant following treatment with LYNPARZA
- Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA
- Do not donate sperm during treatment with LYNPARZA and for 3 months after your last dose
are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time

How should I take LYNPARZA?

Take LYNPARZA tablets exactly as your healthcare provider tells you
Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
Your healthcare provider will decide how long you stay on treatment
Take LYNPARZA by mouth 2 times a day with or without food
Each dose should be taken about 12 hours apart
Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets
If you are taking LYNPARZA for early breast cancer and you have hormone receptor-positive disease, you should continue to take hormonal therapy during your treatment with LYNPARZA
If you are taking LYNPARZA for prostate cancer and you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with LYNPARZA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration)
If you miss a dose of LYNPARZA, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose
If you take too much LYNPARZA, call your healthcare provider or go to the nearest hospital emergency room right away

What should I avoid while taking LYNPARZA?

Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood.

LYNPARZA may cause serious side effects (see above). The most common side effects of LYNPARZA when used alone are:

nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
tiredness or weakness
low red blood cell counts
diarrhea
loss of appetite
headache
changes in the way food tastes
cough
low white blood cell counts
shortness of breath
dizziness
indigestion or heartburn
low platelet counts

The most common side effects of LYNPARZA when used in combination with bevacizumab are:

nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
tiredness or weakness
low red blood cell counts
low white blood cell counts
diarrhea
urinary tract infection
headache

The most common side effects of LYNPARZA when used in combination with abiraterone are:

low red blood cell counts
tiredness or weakness
nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
diarrhea
loss of appetite
low white blood cell counts
dizziness
abdominal pain

These are not all the possible side effects of LYNPARZA. Call your healthcare provider for medical advice about side effects. You may report side effects related to AstraZeneca products(Opens in new window).

Please see complete Prescribing InformationLink opens PDF in a new tab, including Medication GuideLink opens PDF in a new tab.