Get notified of page updates

Update: FDA approves the PARP inhibitor olaparib (Lynparza) in combination with bevacizumab (Avastin) as maintenance therapy for some women with advanced ovarian cancer

Printer Friendly Page

Contents

At a glance                  Questions for your doctor
What does this mean for me? In-depth            
Clinical trials Limitations
Guidelines Resources


APPROVAL AT A GLANCE

What does the approval say?

On May 8, 2020, the Food and Drug Administration approved the use of the olaparib (Lynparza) in combination with bevacizumab (Avastin) as a first-line for women with advanced ovarian cancer who have had a complete or partial response to chemotherapy.

The also approved a test that helps to identify women who will benefit from this combination therapy. The test measures how effectively cancer cells are able to repair damage. Cancer cells that cannot repair damage are more sensitive to certain types of treatment.

The test—called a “”, or “” test—reports whether a tumor is HRD-positive or HRD-negative, based on two features of the cancer cells:

  • The presence or absence of a or tumor mutation. Tumor cells with mutations have difficulty repairing damage.
  • “Genomic instability,” other changes that make it difficult for the tumor cells to repair damage.

HRD-positive tumors have trouble repairing damage, which makes them sensitive to the Lynparza-Avastin drug combination.

Why is this approval important?

Standard treatment for many advanced ovarian cancer patients includes chemotherapy plus bevacizumab (Avastin). Some women receive additional treatment known as with either Avastin or a . This recent approval is the first time a (Lynparza) has been approved in combination with Avastin for in women with ovarian cancer.

PAOLA-1 clinical trial

approval of the Lynparza-Avastin combination was based on results of the ongoing PAOLA-1 clinical trial. All participants had either a partial or a complete response to chemotherapy plus Avastin. After chemotherapy, they were placed in one of two groups:

  • One group received with Lynparza and Avastin.
  • Another group received with Avastin and a .

After follow-up of almost 23 months, patients taking Lynparza plus Avastin had an additional 6 months of progression-free survival compared to patients taking Avastin alone.

  • Among patients with a tumor mutation, patients taking Lynparza plus Avastin had an additional 15 months of progression-free survival compared to patients taking Avastin alone.
  • Among patients whose tumors had , but no mutation, patients taking Lyparza plus Avastin had an additional 11.5 months of progression-free survival compated to patients taking Avastin alone.
  • Patients with tumors that were HRD-negative showed no difference in progression-free survival between the two treatments.
  • No differences in quality-of-life scores were found between the two groups.

The most common side effects of Lynparza plus Avastin included:

  • fatigue
  • nausea
  • anemia
  • vomiting
  • diarrhea
  • urinary tract infection
  • headache
  • low white blood cell counts

This new approval expands the use of Lynparza as a . It can now be prescribed in combination with Avastin as a first-line for advanced ovarian cancer patients whose tumor is HRD-positive.

What is first-line treatment?

First-line treatment is the initial treatment given for a disease, such as cancer. Second-line treatments are used for cancers that return or do not respond to treatment. 

For most women diagnosed with ovarian cancer, first-line treatment usually involves surgery and several months of chemotherapy. Women whose cancer responds well to treatment may stop treatment altogether or stop treatment and start

Women whose cancer comes back will receive second-line treatment, which may be a new course of chemotherapy or another type of treatment. Third-line treatment is recommended for cancers that return or do not respond to treatment.

What is ?

is given after chemotherapy to try to keep the cancer from returning. The goal is to extend the length of time before recurrence or to turn remission into a long-term cure.

What does this mean for me?

If you have ovarian cancer that responded to chemotherapy, you may benefit from using a combined with Avastin.

Share your thoughts on this XRAYS article by taking our brief survey


Reference

Ray-Coquard I, Pautier P, Pignata S, Pérol D, et al. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19. 381(25):2416.
 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is relevant for:

Women with advanced ovarian cancer whose tumor has a BRCA mutation or a type of tumor marker called homologous recombination deficiency (HRD)

This article is also relevant for:

People with a genetic mutation linked to cancer risk

People with ovarian cancer

Be part of XRAY:

IN-DEPTH REVIEW OF RESEARCH RELATED TO APPROVAL

PARP inhibitors are already approved for treatment and as a single-agent for some ovarian cancer patients.

New approval for Lynparza

On May 8, 2020, the Food and Drug Administration approved the olaparib (Lynparza) in combination with bevacizumab (Avastin) as a first-line for women with advanced ovarian cancer. Specifically, it is for women who have had a complete or partial response to chemotherapy and whose tumor has a specific form of genomic instability (called or ).

testing can be used to determine whether a tumor has this genomic instability or . The test counts the number of mutations in a given piece of in tumor cells. The MyChoice CDx test (Myriad Genetics) can determine whether a tumor has . Genomic instability can be caused by inherited or tumor mutations in , or in other genes.

PAOLA-1 clinical trial

Approval of Lynparza in combination with Avastin for was based on the following preliminary results of the ongoing PAOLA-1 clinical trial:

  • After a median follow-up of 22.9 months, median progression-free survival was:
    • 22.1 months for patients taking Lynparza and Avastin.
    • 16.6 months for patients taking Avastin and .
  • When analysis was limited to patients with tumor mutations, median progression-free survival was:
    • 37.2 months for patients taking Lynparza and Avastin.
    • 21.7 months for patients taking Avastin and .
  • When analysis was limited to patients with tumors that only had (inherited or tumor mutation in 1 or ), the median progression-free survival was:
    • 28.1 months for patients taking Lynparza and Avastin.
    • 16.6 months for patients taking Avastin and .
  • Patients with tumors that were HRD-negative or of unknown status showed no difference in progression-free survival between treatment arms.
  • No significant differences in quality of life scores were found between treatment arms.

What does this mean for me?

If you have ovarian cancer that responded to chemotherapy, you may benefit from using a combined with Avastin.

Limitations

Participants in this study were placed into one of two groups:

  • One group received with Avastin alone
  • The other group received with Lynparza and Avastin.

No group received Lynparza only as . The study design makes it difficult to know whether the combination of Lynparza and Avastin is better than Lynparza alone.

Expert Guidelines Expert Guidelines

The National Comprehensive Cancer Network (NCCN) is a panel of experts that creates guidelines for cancer treatment. The following NCCN recommendations are for women with ovarian cancer who have had a complete or partial response to first-line therapy:

  • Women who have a mutation may benefit from a as .
  • Women who have a mutation and had Avastin as part of their first-line treatment may benefit from a alone or Lynparza and Avastin as .
  • Women who do not have a mutation and had Avastin as part of their first-line treatment may benefit from a alone or in combination with Avastin as , depending on their status.
  • Women who do not have a mutation and did not have Avastin as part of their first-line treatment may benefit from a as .
    • Benefit of a for maintenance therapy for ovarian cancer patients regardless of their status was observed in the PRIMA trial which showed that patients taking the niraparib () had an additional 5.6 months of progression-free survival compared to patients taking regardless of status.We reported on the PRIMA trial in this XRAY review.

Expert Guidelines Expert Guidelines

The following NCCN recommendations are for for women with ovarian cancer who have had a complete or partial response to first-line therapy:

  • Women who have a mutation may benefit from a as .
  • Women who have a mutation and had Avastin as part of their first-line treatment may benefit from a alone or Lynparza and Avastin as .
  • Women who do not have a mutation and had Avastin as part of their first-line treatment may benefit from a alone or in combination with Avastin as , depending on their status.
  • Women who do not have a mutation and did not have Avastin as part of their first-line treatment may benefit from a as .

Updated: 12/07/2021

Questions to Ask Questions to Ask Your Doctor

  • Am I eligible for first-line with a ?
  • I just finished second-line chemotherapy; would I benefit from ?
  • I have an inherited mutation; would I benefit from a and Avastin for treatment?
  • What are the risks and benefits of taking a ?
  • What are the differences between PARP inhibitors that are approved for first-line maintenance therapies?

Open Clinical Trials Open Clinical Trials

The following are studies looking at PARP inhibitors and similar agents for treating people with ovarian cancer.  

A number of other clinical trials for people with ovarian cancer can be found here.

Updated: 03/13/2022

Open Clinical Trials Open Clinical Trials

The following are studies looking at treatment for people with advanced

Updated: 06/26/2022

Peer Support Peer Support

The following organizations offer peer support services for people with, or at high risk for ovarian cancer:

Updated: 02/05/2022

Back to XRAY Home