BRCA subgroup boosts Akeega's prostate cancer benefit

Johnson & Johnson's Akeega (niraparib/abiraterone), already approved for BRCA-positive mCRPC, demonstrates promising potential in castration-sensitive prostate cancer, especially within the BRCA subgroup.

Why it matters: 

The findings could redefine treatment protocols, offering extended progression-free survival (rPFS) and enhancing patient quality of life.

• Akeega achieved a 37% reduction in progression or death risk overall, with a striking 48% reduction in the BRCA subgroup.

• While median rPFS was not reached for Akeega users, the placebo group had a median of 29.5 months.

Study insights: 

The Phase III AMPLITUDE study involved 696 mCSPC patients with HRR genetic alterations.

• Akeega, when combined with prednisone and androgen deprivation therapy (ADT), reduced symptomatic progression risk by 50% in the overall population and 56% in the BRCA group.

Safety profile: 

Grade 3/4 adverse events were reported in 74% of Akeega patients, with anemia and hypertension as common issues.

• Treatment discontinuation due to adverse events was 14.7% for Akeega, compared to 10.3% for placebo.

Regulatory status: 

Akeega, alongside prednisone, received EMA and FDA approval in 2023.

What they're saying: 

"Our aim was to extend the time patients live without cancer worsening," said Charles Drake, prostate cancer and immunotherapy leader at J&J. "Akeega is achieving this goal, providing quality time before the disease becomes more resistant."

Future directions: 

Further analysis is needed to determine efficacy across non-BRCA subgroups, with plans for meta-analysis across multiple trials to provide clearer subgroup efficacy insights.