Update: New drug combination approved for treatment of BRCA-mutated metastatic prostate cancer
Summary
The FDA approved Akeega (niraparib and abiraterone) plus prednisone for the treatment of BRCA-mutated, metastatic castration-resistant prostate cancer (mCRPC). Akeega can be used as an early or later treatment. (Posted 11/9/23)
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RELEVANCE
Most relevant for: People with metastatic castration resistant prostate cancer with a mutation in BRCA1 or BRCA2. It may also be relevant for:
- people with castration-resistant prostate cancer
- people with a family history of cancer
- people with a genetic mutation linked to cancer risk
- people with metastatic or advanced cancer
Relevance: Medium-High
Research Timeline: Post Approval
What is this update about?
The has approved Akeega in combination with prednisone as a treatment for castration-resistant cancer (mCRPC) for people with or mutation. Akeega combines acetate and the niraparib into a single tablet.
This approval is based on the results of a large clinical trial called MAGNITUDE. Participants were divided into two groups. Half of them received Akeega ( and ), while the other half received without . All participants received prednisone.
- After two years, compared to people with a or mutation who had a plus prednisone, people with a or mutation who had Akeega plus prednisone:
- reduced their risk of cancer progressing or death by 45%.
- went longer without needing chemotherapy.
- went longer without symptoms of cancer progression (such as the need for bone surgery).
- had improved patient-reported outcomes, including a 30% delay in time-to-pain progression and a 33% delay in time-to-pain interval that interfered with daily activities.
About Akeega
Akeega ( plus acetate) combines the niraparib () and acetate (Zytiga) into one pill. Like other PARP inhibitors, Akeega can be particularly effective against cancers with mutations in and .
The most common side effects in either the Akeega group or group were:
- Anemia (low red blood cell counts)
- High blood pressure (hypertension)
- Constipation
- Lower back pain
Anemia, high blood pressure and constipation were more common in the Akeega group compared to the group. Lower back pain was more common in the group compared to the Akeega group.
What does this mean for me?
Genetic testing and tumor testing for people with mCRPC
- Experts recommend genetic testing for an linked to cancer for everyone diagnosed with mCRPC. Results from this test may affect your treatment options.
- Experts also recommend tumor testing for people with mCRPC to see whether they would benefit from treatment with a . If you have not had tumor testing or you are unsure if you have had it, ask your doctor about ordering additional tests.
- If genetic testing or tumor testing shows that you have a mutation in or , you may benefit from treatment with Akeega.
- If genetic testing or tumor testing shows that you have a mutation in another gene, you may benefit from a or another type of .
You can find more information on and for mCRPC here.
Reference
approves and acetate plus prednisone for BRCA-mutated castration-resistant cancer. news release. August 11, 2023.
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.
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posted 11/9/23
Open clinical trials
The following studies are looking at PARP inhibitors and similar agents for treating people with advanced cancer.
- NCT04592237: Chemotherapy, and for the Treatment of Aggressive Variant Cancer. This study will look at how well the combination of chemotherapy drugs (such as cabazitaxel and carboplatin), a PARP inhibitors (), and an agents (cetrelimab) works for treating people with a rare type of cancer known as aggressive variant cancer (AVPC).
- NCT05005728: XmAb®20717 Alone or in Combination With Chemotherapy or in Patients With Castration-Resistant Cancer. This study will look at the safety and clinical activity of the drug XmAb20717 alone or in combination with standard-of-care anticancer therapies in patients with castration-resistant cancer who have been treated with at least 2 prior lines of treatment.
- NCT03317392: Studying the Medication Given with Radium-223 for Advanced Cancer with Bone . This study is measuring the best dosage for and side effects of the drug combination and radium-223 to treat men with mCRPC that has spread to the bones.
Other clinical trials for people with cancer can be found here.
Updated: 11/09/2023
Related resources
The following resources focus on cancer.
- FORCE cancer resources:
- Information: cancer treatment
- XRAY reviews: cancer
- Video: What's New in Cancer Treatment?
- Video: Sexuality and Intimacy Issues for Men
- Video play list: cancer
- Blog category: cancer
- Malecare has extensive resources for people with cancer.
- National Comprehensive Cancer Network free patient guides:
Updated: 08/06/2022
Expert Guidelines
The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment for people with prostate cancer.
- Testing for MSI-H/dMMR may help identify patients who would benefit from .
- Testing for tumor mutations in HRR genes may help identify patients who would benefit from PARP inhibitors.
- Consider testing for a marker known as (TMB). People with a high (TMB-H) may benefit from .
Updated: 03/01/2023
Expert Guidelines
The National Comprehensive Cancer Network has guidelines regarding which cancer patients should undergo genetic counseling and testing. Men with the following factors should speak with a genetics expert about genetic testing:
- A tumor test result that suggests an (for example, a , or mutation in the tumor that may indicate an in one of those genes).
- A blood relative who tested positive for an in a gene linked to cancer.
- cancer diagnosed at any age.
- Intraductal/cribriform cells found by pathology.
- Cancer that is categorized as very high or high risk based on pathology.
- A diagnosis of male breast cancer.
- Eastern European (Ashkenazi) Jewish ancestry.
- One or more first-, second- or third-degree relatives with breast cancer diagnosed at age 50 or younger, or ovarian, pancreatic, male breast cancer, cancer or intraductal/cribriform cancer at any age.
- Two or more close relatives diagnosed with breast or cancer at any age.
Updated: 03/01/2023
Peer Support
The following organizations offer peer support services for people with or at high risk for cancer:
- FORCE peer support
- Visit our message boards.
- Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Sign up for our Peer Navigation Program.
- Users are matched with a volunteer who shares their mutation and situation.
- Join our private Facebook group.
- Find a virtual or in-person support meeting.
- Join a Zoom community group meeting.
- Visit our message boards.
- ZERO-The End of Cancer is a nonprofit organization that provides information and support resources for men with cancer.
Updated: 03/08/2023