AMPLITUDE Study – BiotechReality – Information Intelligence System for Biopharma

Quick Summary First-of-its-Kind Approval: AKEEGA® is now the first precision-medicine dual-action tablet approved in Europe for patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC). Significant Clinical Benefit: Data from the Phase 3 AMPLITUDE study demonstrated that the AKEEGA® combination reduced the risk of radiographic progression or death by 48% compared to standard care. Targeting High-Risk Patients: This approval addresses a critical unmet need for the ~10% of mHSPC patients with BRCA mutations who typically experience rapid disease progression on conventional therapies. BEERSE, BELGIUM – Johnson & Johnson has announced that the European Commission (EC) has officially approved an indication extension for AKEEGA® (niraparib and abiraterone acetate). This dual-action tablet (DAT), administered with prednisone or prednisolone in combination with androgen deprivation therapy (ADT), is now authorized for the treatment of adult patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC). This milestone marks AKEEGA® as the first precision-medicine combination treatment approved for this specific patient population in Europe. Approximately 10% of patients with mHSPC harbor BRCA1/2 alterations, a group that typically faces a more aggressive disease course and poorer outcomes with standard treatments. Clinical Data Deep-Dive: The AMPLITUDE Study The approval is anchored by data from the Phase 3 AMPLITUDE study, a randomized, double-blind, placebo-controlled international trial. The study evaluated the efficacy and safety of the AKEEGA® combination against a placebo plus abiraterone acetate and prednisone (AAP) in 696 patients with homologous recombination repair (HRR) gene alterations. Key Clinical Efficacy Results: Radiographic Progression-Free Survival (rPFS): In patients with BRCA1/2 mutations, AKEEGA® nearly halved the risk of disease progression or death. At a median follow-up of 30.7 months, the median rPFS for the AKEEGA® group was not yet reached, compared to 26 months for the control group (Hazard Ratio 0.52; p<0.0001). Symptomatic Progression: The combination significantly prolonged the time to symptomatic progression in the BRCA subgroup (HR 0.44; p0.0001). Overall Survival (OS): While follow-up is ongoing, early interim analysis showed a promising trend toward improved survival, with a 20% reduction in the risk of death (HR 0.80) for patients with BRCA mutations. Read More: Johnson & Johnson’s Akeega® Moves Closer to EMA Approval for High-Risk Metastatic Prostate Cancer Study Design & Baseline Characteristics Total Enrollment: 696 patients randomized 1:1 (348 to AKEEGA® + Prednisone; 348 to Placebo + AAP). Population: Patients with deleterious germline or somatic HRR gene alterations (BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, PALB2, RAD51B, RAD54L). Key Metrics: * Median Age: 68 years. Disease Volume: 78% had high-volume metastatic disease (M1). Disease Presentation: 87% were de novo metastatic at diagnosis. Prior Treatment: 16% had received prior docetaxel chemotherapy. Primary Efficacy Endpoint: Radiographic Progression-Free Survival (rPFS) The study demonstrated a profound delay in disease progression, particularly in the BRCA-mutated population. Patient PopulationMedian rPFS (AKEEGA®)Median rPFS (Placebo)Hazard Ratio (HR)P-ValueBRCA1/2 SubgroupNot Reached (NR)26.0 months0.52 (95% CI: 0.37–0.72)<0.0001HRR Effector SubgroupNot Reached27.6 months0.57 (95% CI: 0.42–0.77)0.0003ITT (All HRRm)Not Reached29.5 months0.63 (95% CI: 0.49–0.80)0.0001 Safety Profile The safety of AKEEGA® in the mHSPC setting was found to be consistent with its known profile in metastatic castration-resistant prostate cancer (mCRPC). The most common Grade 3/4 adverse events reported were anaemia and hypertension. Importantly, treatment discontinuation rates due to adverse events remained low, and side effects were generally manageable through dose modifications and standard supportive care. Johnson&Johnson Last Modified:

Tag: AMPLITUDE Study

European Commission Grants Approval for AKEEGA®: A New Precision Medicine Milestone for BRCA-Mutated Metastatic Prostate Cancer

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