Janssen reports updated phase 3 results for niraparib combination in prostate cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) have announced updated results from a phase 3 trial of niraparib in combination with abiraterone acetate plus prednisone (AAP) for certain prostate cancer patients.

Janssen’s ongoing MAGNITUDE study is evaluating the combination treatment in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without certain homologous recombination repair (HRR) gene alterations.

With over 100,000 deaths attributed to the disease in 2020 alone, prostate cancer is the most common cancer in men across Europe.

Patients with mCRPC and HRR gene alterations, of which BRCA mutations are the most common, are more likely to have aggressive disease, poor outcomes and a shorter survival time, Janssen explained.

The company has already submitted a marketing authorisation application to the European Medicines Agency for the niraparib-AAP combination, based on earlier data from the study, with applications also under review in a number of countries.

The second interim analysis of the study, which will be presented at this year’s American Society of Clinical Oncology’s Genitourinary Cancers Symposium, continues to demonstrate improved outcomes in the combination treatment group compared to AAP plus placebo.

At 26.8 months of median follow-up, the combination showed a statistically significant increase in the time taken for symptoms to progress, as well as continued improvement of time-to-initiation of cytotoxic chemotherapy in the HRR-positive patient population.

A strong improvement in the time to symptomatic progression was also seen in the BRCA subgroup of the HRR-positive population, the company said.

Updated radiographic progression-free survival results were also consistent with the primary analysis, which showed statistically significant benefit in both the HRR-positive population and BRCA subgroup, where a trend towards improvement in overall survival was observed.

Martin Vogel, EMEA therapeutic area lead for oncology at Janssen-Cilag GmbH, said in addition to the positive results for the niraparib-AAP combination, the study highlights the importance of biomarker testing to identify those who will optimally benefit from the treatment.

Vogel added: “This is a crucial step in ensuring we can bring the right treatment to the right patients, based on their unique characteristics, and speaks to our wider commitment to exploring precision medicine to treat, intercept and prevent, and potentially one day cure, diseases like mCRPC.”