Johnson & Johnson Reports Positive Results From Phase 3 AMPLITUDE Study In Prostate Cancer

(RTTNews) - Johnson & Johnson (JNJ) Tuesday reported encouraging results from the Phase 3 AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate (Akeega) plus prednisone in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA.

The study met its primary endpoint of radiographic progression-free survival (rPFS).

Results from the study showed that treatment with the niraparib combination reduced the risk of symptomatic progression by 56 percent in patients with BRCA mutations and 50 percent in patients with HRR mutations. This meant that patients experienced a longer delay in symptoms worsening and requiring radiation, surgery, or new anti-cancer therapy.

"The AMPLITUDE trial is the first to show that combining a PARP inhibitor with an androgen receptor pathway inhibitor both delays disease progression and postpones the onset of symptoms in HRR-altered mCSPC, supporting this combination as a new treatment option for these patients," said Gerhardt Attard, M.D., John Black Charitable Foundation Chair of Medical Oncology, University College London Cancer Institute, Research Department of Oncology and presenting author.