In patients with ovarian cancer who have had a response to platinum-based chemotherapy, treatment with niraparib (Parp inhibitor), as a first-line maintenance therapy, has provided lasting clinical benefits in terms of progression-free survival. The data of the ‘Before’ study (phase 3) presented at the European Society of Medical Oncology (Esmo) congress in Paris. The pharmaceutical company announces it Gsk noting that this benefit was maintained in all biomarker subgroups, including Brcam, Hrd and Hrp.
In particular, in HRD patients, it is estimated that niraparib is more than twice as likely to have no disease progression or death at four years compared to placebo. In detail, after a median follow-up of three and a half years, the ad hoc analysis showed that, in the HRD population, niraparib maintained a clinically significant reduction in the risk of progression or death of 48% compared to placebo. The estimated probability of no disease progression or death at four years was 38% for niraparib and 17% for placebo, respectively.
The drug maintained a lasting benefit in terms of disease-free survival in the overall population. The estimated probability of no disease progression or death at four years in the overall population was 24% for niraparib and 14% for placebo, respectively. In the HRP population, treatment also demonstrated a clinically significant reduction in the risk of progression or death of 35% compared to placebo. “Patients with advanced ovarian cancer have a high risk of recurrence. The updated analysis of this study shows that niraparib can help these patients potentially achieve long-term remission, “said Hesham Abdullah, senior vice president, Global Head of oncology development, Gsk.
Overall survival data are not yet available. The safety profile of niraparib remained consistent with the primary analysis. The most common grade three or higher adverse events included thrombocytopenia (40%), anemia (32%), and neutropenia (21%). Long-term monotherapy treatment was associated with a low discontinuation rate due to adverse events, a potentially important factor in achieving lasting therapeutic benefit.
“This study provides evidence that patients treated with niraparib maintenance therapy after first-line platinum-based chemotherapy can achieve progression-free survival and maintain remission over time, which is of paramount importance in the management of advanced ovarian cancer and particularly reassuring for those at high risk of recurrence. The long-term results not only show the continued benefit of niraparib for study participants, but also offer hope for the future of patients with advanced ovarian cancer, “he said. Antonio Gonzalez-Martinlead partner of Prima researchers and director of the Department of Medical Oncology, Clinica Universidad de Navarra (Spain).
Niraparib is the only oral monotherapy maintenance treatment to be taken once daily approved in the United States and the European Union for patients with platinum-sensitive advanced first-line ovarian cancer, regardless of biomarker status.