Clinical Trial Results

ZEJULA has two FDA-approved uses for women with advanced ovarian cancer (including epithelial ovarian, fallopian tube, or primary peritoneal cancer). See the results from its clinical trials—PRIMA and NOVA. 

ZEJULA: FIRST-LINE MAINTENANCE TREATMENT

PRIMA clinical trial

 

ZEJULA has been studied and continues to be studied in a trial called PRIMA, which measured median progression-free survival, or mPFS. In the PRIMA trial, two populations were studied, the overall trial population and a subset of the overall trial population, the HRD-positive population.

 

Helpful terms to know:


mPFS refers to the length of time during and after treatment that patients live with cancer, but it does not get worse.


Median is the middle number in a set of data, also called the midpoint. It means that half of the number are greater than the median, and half are less.


HRD, or homologous recombination deficiency, occurs when cells have difficulty repairing themselves and appears in about 50% of women with ovarian cancer.


BRCA refers to genes that produce proteins that repair damaged DNA. Changes (also called mutations) in the BRCA gene may mean that these proteins no longer function and could increase the risk of developing cancer.

In the PRIMA trial, ZEJULA offered more time without cancer returning

 

The trial is ongoing to see if patients live longer overall with treatment.

Overall Trial Population Results - ZEJULA delayed disease progression or death for a median of 14 months vs 8 months with placebo

Details at a glance

  • 733 patients participated 
    • Included patients with newly diagnosed advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy 
    • Included patients with and without a positive test result for HRD 
    • Patients received treatment with either ZEJULA or a placebo (did not receive ZEJULA) 
HRD-Positive Population Results - ZEJULA delayed disease progression or death for a median of 22 months vs 10 months with placebo

Details at a glance

  • 373 patients participated 
    • Included patients with newly diagnosed advanced ovarian cancer, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy
    • Included patients from the overall trial population with a positive test result for HRD
    • Some of these HRD-positive patients were also BRCA-positive
    • Patients received treatment with either ZEJULA or a placebo (did not receive ZEJULA) 

ZEJULA: MAINTENANCE TREATMENT FOR RECURRENT gBRCAm OVARIAN CANCER

NOVA clinical trial

ZEJULA was studied in a trial called NOVA, which measured median progression-free survival, or mPFS.

 

Helpful terms to know:

mPFS refers to the length of time during and after treatment that patients live with cancer, but it does not get worse.

 

Median is the middle number in a set of data, also called the midpoint. It means that half of the number are greater than the median, and half are less.

 

BRCA refers to genes that produce proteins that repair damaged DNA. Changes (also called mutations) in the BRCA gene may mean that these proteins no longer function and could increase the risk of developing cancer. When the BRCA mutation is inherited, it’s referred to as germline or gBRCA.

NOVA clinical trial results

Results - ZEJULA delayed disease progression for a median of 21 months vs 6 months with placebo

Details at a glance

  • 203 patients participated
    • Included patients with an inherited germline BRCA-mutated (gBRCAm) ovarian, fallopian tube, or primary peritoneal cancer
    • Included patients who received at least two courses of platinum-based chemotherapy and had a complete or partial response to the most recent course of platinum-based chemotherapy
    • Patients received treatment with either ZEJULA or a placebo (did not receive ZEJULA)
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Understanding side effects

Learn what to look for and how to partner with your healthcare team to address potential side effects. It's important to keep your doctor informed about any side effects you may be feeling.

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Whether you’re on ZEJULA or just looking to learn more, ZEJULA My Way is here for you.

Approved Uses & Safety Info

Approved Uses

ZEJULA is a prescription medicine used for the:

  • maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
  • maintenance treatment of adults with a certain type of inherited (germline) abnormal BRCA gene with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that ZEJULA is right for you.  

 

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

Important Safety Information

ZEJULA may cause serious side effects, including:

 

Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with ZEJULA. MDS or AML may lead to death.

 

Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA. They can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:

  • Weakness
  • Feeling tired
  • Weight loss
  • Frequent infections
  • Fever
  • Shortness of breath
  • Blood in urine or stool
  • Bruising or bleeding more easily


Your doctor will do blood tests to check your blood cell counts before treatment with ZEJULA. You will be tested weekly for the first month of treatment with ZEJULA, monthly for the next 11 months of treatment, and as needed afterward.

 

High blood pressure is common during treatment with ZEJULA, and it can become serious. Your doctor will check your blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and as needed thereafter during your treatment with ZEJULA.

 

Posterior reversible encephalopathy syndrome (PRES) is a condition that affects the brain and may happen during treatment with ZEJULA. If you have headache, vision changes, confusion, or seizure, with or without high blood pressure, please contact your doctor.

 

Before starting to take ZEJULA, tell your doctor about all of your medical conditions, including if you:

  • Have heart problems
  • Have liver problems
  • Have high blood pressure
  • Are pregnant or plan to become pregnant. ZEJULA can harm your unborn baby and may cause loss of pregnancy (miscarriage)
    • If you are able to become pregnant, your doctor should perform a pregnancy test before you start treatment with ZEJULA
    • If you are able to become pregnant, you should use effective birth control (contraception) during treatment with ZEJULA and for 6 months after taking the last dose of ZEJULA
    • You should tell your doctor right away if you become pregnant
  • Are breastfeeding or plan to breastfeed
    • ZEJULA may harm your baby. You should not breastfeed your baby during treatment with ZEJULA and for 1 month after taking the last dose of ZEJULA


Tell your doctor about all the medicines you take,
 including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

The most common side effects of ZEJULA include the following:

  • Nausea
  • Tiredness
  • Constipation
  • Pain in your muscles and back
  • Pain in the stomach area
  • Vomiting
  • Loss of appetite
  • Trouble sleeping
  • Headache
  • Shortness of breath
  • Rash
  • Diarrhea
  • Cough
  • Dizziness
  • Changes in the amount or color of your urine
  • Urinary tract infection
  • Low levels of magnesium in the blood


If you have certain side effects, then your doctor may change your dose of ZEJULA, temporarily stop, or permanently stop treatment with ZEJULA.

 

These are not all the possible side effects of ZEJULA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

 

Please see accompanying full Prescribing Information for ZEJULA.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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