The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone or prednisolone compared to a current standard of care, abiraterone acetate plus prednisone or prednisolone

 Janssen-Cilag International NV, a Johnson & Johnson company, announced the submission of an extension of indication application to the European Medicines Agency (EMA) seeking approval of AKEEGA  (niraparib and abiraterone acetate) with prednisone or prednisolone for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and homologous recombination repair (HRR) gene alterations.

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mHSPC is a form of prostate cancer that has spread to other parts of the body, but still responds to hormone therapy. 2 While the treatment landscape has advanced in recent years, almost all patients eventually develop resistance to therapy, and the disease progresses to metastatic castration-resistant prostate cancer (mCRPC) – an aggressive and currently incurable disease stage. 3 Over 20 percent of patients with mHSPC have HRR gene alterations, including alterations in BRCA1/2, which have been shown to negatively impact outcomes.  These patients have an unmet medical need which existing therapies do not address. 

“Despite significant progression in prostate cancer, individuals with HRR gene alterations often face limited treatment options, faster onset of symptoms and poorer outcomes,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapy Area Head, Oncology, Johnson & Johnson Innovative Medicine. “With this submission to the EMA, we have the opportunity to offer patients with HRR-mutated mHSPC a treatment specifically targeted to the underlying biology of their disease. Pending approval, this niraparib-based combination will help redefine the standard of care for this high-risk population, significantly delaying the time to their cancer progressing. This milestone reflects our commitment to advancing precision medicine in earlier stages of disease.”

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The submission was supported by data from the Phase 3 AMPLITUDE study ( NCT04497844 ), evaluating the efficacy and safety of niraparib and abiraterone acetate plus prednisone or prednisolone (AAP) for the treatment of patients with mHSPC with HRR gene alterations, versus placebo plus AAP. 1, 5 The study demonstrated clinically meaningful and statistically significant outcomes in the primary endpoint of radiographic progression-free survival (rPFS), and the key secondary endpoint of time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS) – highlighting the clinical benefits of niraparib and abiraterone acetate plus prednisone or prednisolone in delaying both cancer progression and the worsening of symptoms versus the current standard of care.  AMPLITUDE is the first study to show the efficacy of combining a poly (ADP-ribose) polymerase (PARP) inhibitor and androgen receptor pathway inhibitor (ARPI) in this patient population.

The safety profile of niraparib and abiraterone acetate plus prednisone or prednisolone is consistent with that observed in metastatic castration-resistant prostate cancer (mCRPC), for which niraparib and abiraterone acetate is currently approved.  The most common Grade 3/4 adverse events (AEs) with the niraparib combination were anaemia and hypertension; however, treatment discontinuations due to AEs remained low. 

“At Johnson & Johnson, we remain committed to addressing the needs of individual patients by pushing the boundaries of science and innovation to deliver more personalized and effective treatment options at every stage of the prostate cancer journey,” said Charles Drake, MD, Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, at Johnson & Johnson Innovative Medicine. “The fixed dose combination of niraparib and abiraterone acetate has already had a positive impact in shifting the treatment paradigm for patients with metastatic castration-resistant prostate cancer, and we now look forward to extending this benefit to those with hormone-sensitive disease.”

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Source – GlobeNewswire