Update: New drug combination approved for treatment of BRCA-mutated metastatic prostate cancer

Relevance: Medium-High

Research Timeline: Post Approval

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What is this update about?

The FDA has approved Akeega in combination with prednisone as a treatment for metastatic castration-resistant prostate cancer (mCRPC) for people with BRCA1 or BRCA2 mutation. Akeega combines abiraterone acetate and the PARP inhibitor 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 (abiraterone and niraparib), while the other half received abiraterone without niraparib. All participants received prednisone.

• After two years, compared to people with a BRCA1 or BRCA2 mutation who had a placebo plus prednisone, people with a BRCA1 or BRCA2 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 (niraparib plus abiraterone acetate) combines the PARP inhibitor niraparib (Zejula) and abiraterone acetate (Zytiga) into one pill. Like other PARP inhibitors, Akeega can be particularly effective against cancers with mutations in BRCA1 and BRCA2.

The most common side effects in either the Akeega group or abiraterone 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 placebo group. Lower back pain was more common in the placebo 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 inherited mutation linked to prostate cancer for everyone diagnosed with mCRPC. Results from this test may affect your treatment options.
• Experts also recommend tumor biomarker testing for people with mCRPC to see whether they would benefit from treatment with a targeted therapy. If you have not had tumor biomarker 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 BRCA1 or BRCA2, 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 PARP inhibitor or another type of targeted therapy.

You can find more information on targeted therapy and immunotherapy for mCRPC here.

Reference

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer. FDA 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