ZEJULA Efficacy

ZEJULA works to slow the return or progression of cancer1,2

ZEJULA is a PARP inhibitor, which means it can help prevent cancer cells from repairing their damaged DNA. This may slow the return or the progression of cancer. ZEJULA can also affect other cells and tissues in the body.1,3

In the clinical trial, ZEJULA helped women with and without a BRCA mutation1

ZEJULA was evaluated as a maintenance treatment in a double-blind, placebo-controlled phase 3 trial of 553 women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who1*

  • Received at least 2 platinum-based chemotherapy treatments, and
  • Had a complete or partial response to the most recent chemotherapy

The study was designed to measure how long women lived with epithelial ovarian, fallopian tube, or primary peritoneal cancer without their disease getting worse. The treatment benefit of ZEJULA was independently tested in women with the BRCA gene and women without the BRCA gene.1

The women who took part in the clinical trial were divided into 2 groups based on BRCA status. Women with an inherited change (also called a mutation) in the BRCA gene (known as BRCA-positive) were in 1 group. Women without an inherited change in the BRCA gene (known as BRCA-negative) were in the other group.1,4

*65 women who were BRCA-positive received a placebo (eg, sugar pill), and 116 women who were BRCA-negative received a placebo.

ZEJULA offered more time without progression, regardless of BRCA status

ZEJULA offered nearly 4X more time in response for women with an inherited BRCA mutation vs watch and wait (placebo)1

The clinical trial of ZEJULA measured median progression-free survival, or PFS. PFS means the length of time during and after treatment that you live with cancer but it does not get worse.1,2,5

Women who had an inherited BRCA mutation (BRCA-positive)

Women who did not have an inherited BRCA mutation (BRCA-negative)

Information from the 2 groups (those with and those without an inherited BRCA mutation) was analyzed. In the group with women who were BRCA-positive (those with an inherited BRCA mutation), the analysis estimated that half of the women who received ZEJULA experienced disease progression after 21.0 months compared with 5.5 months for women who received placebo. Similarly, for the women who were BRCA-negative (those without an inherited BRCA mutation), the analysis estimated that half of the women who took ZEJULA experienced disease progression after 9.3 months compared with 3.9 months for those who took placebo. These halfway points are referred to as median progression-free survival.1

Median is the middle number in a set of data, also called the midpoint. It means that half of the numbers are greater than the median and half are less.6

Women taking ZEJULA had less risk of disease progression

The risk of progression decreased by1:

74 percent

for women who had an inherited mutation (BRCA-positive)

55 percent

for women who did not have an inherited mutation (BRCA-negative)

While not all women in the clinical study responded to ZEJULA, it has been shown to help after a complete or partial response to platinum-based chemotherapy.

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Used Terms

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References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2018. 2. Mirza MR, Monk BJ, Herrstedt J, et al; for the ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164. 3. Sandhu SK, Schelman WR, Wilding G, et al. The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2013;14(9):882-892. 4. NCI Dictionary of Cancer Terms: BRCA. National Cancer lnstitute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/search?containS=false&q=BRCA. Accessed May 4, 2018. 5. NCI Dictionary of Cancer Terms: Progression-free Survival. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/progression-free-survival. Accessed May 3, 2018. 6. Median. Merriam-Webster website. https://www.merriam-webster.com/dictionary/median. Accessed May 3, 2018.

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