Update: New FDA approval of PARP inhibitor for maintenance therapy in ovarian cancer
|At a glance||Clinical trials|
|What is ?||Guidelines|
|What is first-line treatment?||Questions for your doctor|
|What does this mean for me?||Resources|
This update is about:
On April 29, 2020, the U.S. Food and Drug Administration approved , () as a first-line for women with advanced ovarian cancer who have had a complete or partial response to chemotherapy. is a type of known as a . This approval applies to women both with, and women without a mutation.
is a type of treatment that is given after chemotherapy treatment has been completed to try to keep the cancer from returning. The goal of is to extend the length of time before a new recurrence emerges or even to turn a temporary remission into a long-term cure. Two types of agents—PARP inhibitors and bevacizumab—have been approved for use as in women with advanced ovarian, and primary peritoneal cancer.
First-line treatment or therapy is the first treatment given for a disease such as cancer. Second-line treatments are used if the cancer doesn’t respond to first-line treatment or the cancer returns.
After a woman has been diagnosed with ovarian cancer, first-line treatment is usually several months of chemotherapy. If her cancer responds well to treatment, she may stop treatment or begin , unless her cancer comes back. If her cancer comes back, she will receive second-line treatment which maybe a new course of chemotherapy or another type of treatment. If her cancer does not respond, or comes back again, the following treatment would be called third-line.
Why is this approval important?
Treatment of ovarian cancer remains a challenge. Most ovarian cancers respond well to chemotherapy; however, the majority will recur within five years. Until now, PARP inhibitors were only approved for the following situations:
- As treatment for recurrent advanced ovarian cancer in women with a or mutation (found through genetic testing or tumor testing) who have received two or more previous lines of treatment
- As for women with a or who have completed first-line (or higher) chemotherapy
- As for women without a or mutation who completed at least second-line (or higher) chemotherapy.
This is the first approval that allows women with advanced ovarian cancer without a mutation to use a as after first-line treatment.
approval of was based on previous research from the PRIMA trial, which we reported in this XRAY review.
PRIMA looked at whether was safe and effective as after a response to chemotherapy (before recurrence) in women with newly diagnosed ovarian cancer:
- Women who received after completing chemotherapy survived longer without their cancer coming back than women who received after completing chemotherapy. This is known as progression-free survival. Women who received as after completing treatment:
- had an average progression-free survival time of almost 14 months compared to 8 months for patients who received a after completing treatment.
- had an overall survival rate after two years rate of 84 percent, compared to 77 percent for patients who received a .
- caused severe, but not life-threatening side effects in 65 percent of patients enrolled in the study. The most common side effects seen with include:
- low blood counts (e.g., anemia, low platelet count and low white blood cell count)
- abdominal pain
Low blood cell counts were managed by reducing the dose of or taking a break from treatment.
If you have been diagnosed with advanced ovarian cancer and you have had a complete or partial response to chemotherapy, you may want to talk to your doctor about with or another .
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This article is relevant for:
People with advanced ovarian cancer who have had a complete or partial response to chemotherapy
This article is also relevant for:
People with platinum-sensitive ovarian cancer
Women under 45
Women over 45
Be part of XRAY:
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 .
- Is with an option for my ovarian cancer?
- If is not an option for me right now, might it be an option in the future?
- What side effects might I experience with this treatment?
- If I have serious side effects, will I need to stop treatment?
- Are any other agents available to treat my cancer?
The following are studies looking at PARP inhibitors and similar agents for treating people with ovarian cancer.
- NCT03462342 Combination ATR inhibitor and in Recurrent Ovarian Cancer (CAPRI). This study will look at how well patients with recurrent ovarian cancer respond to treatment with a known as an ATR inhibitor when combined with a .
- NCT04586335: Study of CYH33 in Combination With Olaparib an Oral in Patients With Advanced . The purpose of this study is to assess the safety, tolerability and preliminary efficacy of the CYH33 in combination with olaprib in patients with DDR gene mutations and/or PIK3CA mutations, in patients who have progressed on prior , and in patients with recurrent high grade serous ovarian, , or primary peritoneal cancer who are platinum resistant or refractory.
- NCT03579316: Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Cancer. This studies how well adavosertib with or without olaparib work in patients with ovarian cancer that has come back (recurrent).
- NCT04267939: ATR Inhibitor Plus Study in Advanced and Ovarian Cancer. This study will look at how well how well people with advanced ovarian cancer or other respond to treatment with the BAY1895344 in combination with the . This study is open to people whose ovarian cancer progressed on a .
A number of other clinical trials for people with ovarian cancer can be found here.
The following are studies looking at treatment for people with advanced .
- NCT05252390: NUV-868 Alone and in Combination With PARP Inhibitors in Patients With Advanced . This study will test how safe and effective the experimental drug NUV-868 is by itself and in combination with a in people with advanced . This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
- NCT05169437: () in patients with inherited or tumor mutations in advanced (PAVO). PAVO is a Phase II study investigating if the study drug, a called , is safe and effective for certain people who have been diagnosed with an advanced solid tumor with either an inherited or tumor mutation.
- NCT02264678: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents. This is a study of ceralasertib administered orally in combination with chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced cancer. The study is enrolling people with inherited mutations including , , , , and people with tumors that are HRD-positive.
- NCT04644068: Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (PETRA). This research is designed to learn if treatment with a new , AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced . The study is open to people who have previously been treated with PARP inhibitors.
- NCT04267939: ATR Inhibitor Plus Study in Advanced and Ovarian Cancer. This study will look at how well how well people with advanced respond to treatment with the BAY1895344 in combination with the . This study is open to people with inherited mutations in , , and others. Contact the study coordinator for information about eligilibity for people with mutations in other genes.
- NCT04657068: Treatment with ATR Inhibitor for Advanced or Solid Tumors. This study will look at how well a new oral known as an ATR inhibitor works on advanced or with mutations in genes linked to damage repair. This study is open to people who have an inherited or acquired or mutation or people with tumors that are HRD-positive. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
The following organizations offer peer support services for people with or at high risk for ovarian cancer:
- FORCE peer support
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with others who have been diagnosed.
- Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Private Facebook Group
- Virtual and in-person support meetings
- Join a Zoom community group meeting.
- American Sign Language
- People of Color
- National Ovarian Cancer Coalition
- Ovarian Cancer Research Alliance
- Clearity Foundation
Who covered this study?
FDA approves Niraparib for frontline maintenance in ovarian cancer This article rates 3.5 out of 5 stars
New York Times
U.S. FDA gives broader approval to GSK's Zejula for ovarian cancer This article rates 3.0 out of 5 stars