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ZEJULA

Clinical Trial Results

For Maintenance Treatment

ZEJULA (niraparib) is a once-daily oral medication that has 3 FDA-approved uses for women with ovarian cancer.*

If you’ve responded to first-line platinum-based chemotherapy, ZEJULA may be an option for you.

Woman standing over table smiling

ZEJULA as a first-line maintenance treatment may offer women more time without their advanced ovarian cancer recurring.

The PRIMA trial, which is still ongoing, included 733 women with newly diagnosed advanced ovarian cancer* who had a complete or partial response to platinum-based chemotherapy. The trial included women with and without a positive test result for certain genetic characteristics called HRD. The HRD-positive group included women who were BRCA-positive.

 

Women received treatment with either ZEJULA or a placebo. The trial measured median progression-free survival, or mPFS. PFS means the length of time during or after treatment that you live with cancer but it does not get worse. Median is the middle number in a set of data, also called the midpoint. ZEJULA delayed disease progression for a median of 14 months vs 8 months with placebo. Results will vary depending on the individual. The trial is ongoing to see if patients live longer overall with treatment.

*Including epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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 a set of genes called BRCA1 and BRCA2. Mutations in BRCA genes increase a woman’s risk of developing ovarian cancer, but having a BRCA mutation does not mean a woman will develop ovarian cancer. BRCA mutations can be inherited, or passed from parents to their children.

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ZEJULA may offer more time without cancer recurring, regardless of certain genetic characteristics

The trial is still ongoing to see if patients, including those with and without HRD positivity, live longer overall with treatment.

Overall study population (733 women)

Received ZEJULA

14

months median delayed disease progression

Received placebo

(did not receive ZEJULA)

8

months median delayed disease progression

In the overall study population, ZEJULA reduced the risk of disease progression by 38% compared with placebo

38% Less Risk
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ZEJULA may offer more time without cancer recurring

Of all women in the PRIMA trial, 373 were HRD-positive. This group included women who were BRCA-positive. Women who received ZEJULA did not see their cancer progress for a median of 22 months vs 10 months on placebo.

HRD-positive population (373 women)

Received ZEJULA

22

months median delayed disease progression

Received placebo

(did not receive ZEJULA)

10

months median delayed disease progression

In HRD-positive women, ZEJULA reduced the risk of recurrence by 57% compared with placebo

57% Less Risk

Please see Side Effects to learn more.

If your ovarian cancer has recurred and you’ve responded to platinum-based chemotherapy, ZEJULA may be an option for you.

Group of people cheers

ZEJULA as maintenance therapy for recurrent ovarian cancer may offer women more time without their cancer returning

The NOVA trial included 553 women with recurrent ovarian cancer* who had received at least 2 courses of platinum-based chemotherapy and had a complete or partial response to the most recent course of platinum-based chemotherapy. In the trial, women received treatment with either ZEJULA or a placebo.

The trial measured median progression-free survival, or mPFS. PFS means the length of time during or after treatment that you live with cancer but it does not get worse. Median is the middle number in a set of data, also called the midpoint.

Of the women that received ZEJULA, 37% had an inherited mutation in the BRCA§ gene (BRCA-positive) and 63% did not (BRCA-negative).||

*Including epithelial ovarian, fallopian tube, or primary peritoneal cancer.
§BRCA refers to a set of genes called BRCA1 and BRCA2. Mutations in BRCA genes increase a woman’s risk of developing ovarian cancer, but having a BRCA mutation does not mean a woman will develop ovarian cancer. BRCA mutations can be inherited, or passed from parents to their children.
||65 women with an inherited BRCA mutation received a placebo and 116 women without an inherited BRCA mutation received a placebo.

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ZEJULA offered nearly 4X more time without cancer recurring for women with an inherited BRCA mutation vs placebo

In the NOVA trial, women with an inherited BRCA mutation who received ZEJULA had more time without their cancer recurring compared to women who did not receive ZEJULA.

Women with an inherited BRCA mutation (203 women)

Received ZEJULA

21

months median delayed disease progression

Received placebo

(did not receive ZEJULA)

6

months median delayed disease progression

In women with an inherited BRCA mutation, ZEJULA reduced the risk of progression by 74% compared with placebo

Not all women in the clinical study responded to ZEJULA.

74% Less Risk
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ZEJULA offered over 2X more time without cancer recurring for women without an inherited BRCA mutation vs placebo

In the NOVA trial, women without an inherited BRCA mutation who received ZEJULA had more time without their cancer recurring compared to women who did not receive ZEJULA.

Women without an inherited BRCA mutation (350 women)

Received ZEJULA

9

months median delayed disease progression

Received placebo

(did not receive ZEJULA)

4

months median delayed disease progression

In women without an inherited BRCA mutation, ZEJULA reduced the risk of progression by 55% compared with placebo

Not all women in the clinical study responded to ZEJULA.

55% Less Risk

Please see Side Effects to learn more.

If you currently have advanced ovarian cancer and have received at least 3 courses of chemotherapy, ZEJULA may still be an option.

Learn more about the QUADRA clinical trial results.

 

 

See Results

 

Frequently Asked
Questions

How do I take ZEJULA?

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What are the possible side effects of ZEJULA?

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Who should consider ZEJULA?

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