Maintenance therapy with olaparib arrives in Italy for metastatic pancreatic cancer with BRCA mutation. Reduced the risk of the disease worsening by 47%.
A decision destined to impact the treatment of one of the most aggressive neoplasms. The Italian Medicines Agency has approved the reimbursement of olaparib as maintenance therapy for patients with metastatic pancreatic adenocarcinoma carriers of germline BRCA1/2 mutationwhose disease has not progressed after at least 16 weeks platinum-based chemotherapy. In 2024 in Italy they have been estimated almost 14 thousand new cases of pancreatic cancer. About the 7% of patients presents a mutation of the BRCA1 or BRCA2 genes, a subgroup for which a targeted therapeutic perspective is now opening up.
Data from the POLO study published in the New England Journal of Medicine
The effectiveness of olaparibprogenitor of PARP inhibitorswas demonstrated in the international phase III POLO study, published in the New England Journal of Medicine. The trial involved 154 patients with BRCA mutated metastatic pancreatic cancer who had achieved disease stabilization after platinum chemotherapy. There progression-free survival was almost doubled: 7.4 months with olaparib versus 3.8 months with placebowith one 47% reduction in the risk of progression. Even the three-year survival showed an advantage: 33.9% in the treated group compared to 17.8% in the placebo group. To date, no maintenance strategy has demonstrated such a significant benefit in this clinical setting.
Precision medicine in pancreatic cancer
The approval of olaparib in Metastatic pancreatic cancer with BRCA mutation fits into the path of precision medicinealready consolidated in other neoplasms related to BRCA genes such as breast and ovary. The availability of reimbursement makes access to the central BRCA genetic test for the diagnosis of pancreatic cancer. Identification of the mutation not only guides the therapeutic choice – first chemotherapy with platinum, then maintenance with olaparib – but also allows carrier family members to be identified and included in cancer prevention programmes.
Italian real world study: reduction in risk of death by 43%
The data from an independent Italian study published in Cancer Medicine has strengthened the clinical evidence. The analysis, conducted in 23 oncology centers on 114 patients with BRCA mutated metastatic pancreatic adenocarcinomaevaluated the use of olaparib in daily clinical practice. In patients treated with the PARP inhibitorin any therapeutic line including the maintenance phase, a 43% reduction in risk of deathconfirming in the real world the benefit already highlighted in the registration study.
Pancreatic cancer: one of the most difficult prognoses
The pancreatic cancer remains among the solid tumors with the most severe prognosis. The absence of screening programs and the late onset of symptoms mean that only 20% of cases are diagnosed at an early stage, when surgery is still potentially curative. For decades the management ofadvanced pancreatic adenocarcinoma it has relied almost exclusively on chemotherapy, with significant toxicity and few options after the first line. The introduction of olaparib in patients with BRCA mutation it therefore represents a paradigm shift: targeted treatment on a molecular basis in a disease historically poor in therapeutic targets.
A turning point for a minority of patients
The audience remains limited, but in a clinical context characterized by few significant innovations, the benefit demonstrated by olaparib marks an important step. The integration between genetic diagnostics and target therapy redefines the approach to metastatic pancreatic cancerpaving the way for increasingly personalized strategies.
