A trial of niraparib for ovarian cancer that has come back after platinum chemotherapy (NOVA)

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 3

This trial looked at a drug called niraparib for ovarian cancer, fallopian tube cancer or primary peritoneal cancer. It was for women whose cancer had come back after treatment with chemotherapy that included a platinum drug.

More about this trial

Ovarian cancer, fallopian tube cancer and primary peritoneal cancer are all similar and treated in the same way. So when we use the term ovarian cancer in this summary, we are referring to all 3.

Doctors treat ovarian cancer with surgery and chemotherapy. Chemotherapy that includes a platinum drug, such as carboplatin, often works well. But after a while the cancer may start to grow again. If this happens you may have more chemotherapy, and the cancer can get smaller or go away completely. But it can start growing again later on.

Researchers are looking for new treatments to help stop ovarian cancer coming back after two courses of chemotherapy. In this trial, they looked at a drug called niraparib.

Niraparib is a type of targeted cancer drug called a PARP inhibitor. This means it blocks an enzyme Open a glossary item called PARP, which helps damaged cells to repair themselves. Doctors hoped that if they could stop PARP working, cancer cells would not be able to repair themselves and the cancer would stop growing.

The aim of the trial was to see if niraparib helped stop advanced ovarian cancer coming back again.

Summary of results

This trial showed that niraparib did help stop ovarian cancer coming back after platinum chemotherapy.

This trial recruited 553 women with advanced ovarian cancer. They’d all had two courses of platinum chemotherapy. Some of the women taking part had a change (mutation) in a gene called BRCA1 or BRCA2, and some didn’t. The research team wanted to find out if having a mutation affected how well the treatment worked.

All the women taking part were put into one of two treatment groups at random. Neither they nor their doctor knew which treatment they were having. This is called a double blind trial.

203 women taking part had a BRCA gene mutation, and of these:

138 had niraparib tablets
65 had dummy (placebo) tablets

350 women taking part didn’t have a BRCA gene mutation, and of these:

234 had niraparib tablets
116 had placebo tablets

NOVA Diagram

The research team looked at how long it was before the cancer started to grow again. They found the most common length of time was:

21 months for those with a BRCA gene mutation who had niraparib
5.5 months for those with a BRCA gene mutation who had the placebo

9.3 months for those without a BRCA gene mutation who had niraparib
3.9 months for those without a BRCA gene mutation who had the placebo

NOVA Diagram

When the research team did the analysis in 2016, it was too early to tell if niraparib helped these women live longer or not.

They also looked at the side effects. Niraparib did cause some side effects, but most were not serious and were manageable. About 1 out of every 7 people (14%) changed to a lower dose or stopped treatment for short while, because of side effects.

The most common side effects of niraparib were:

a drop in red blood cells, white blood cells or platelets
feeling or being sick
tiredness
constipation

The research team also assessed people’s quality of life as part of this trial. They found that it was similar in both groups, it wasn’t lower for people who had niraparib.

The research team concluded that niraparib helped stop ovarian cancer coming back for longer. This was the case for women with a BRCA gene mutation, and those without. And it didn’t reduce quality of life.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.