Pancreatic cancer, Aifa approves olaparib With target therapy -47% risk of progression

The Medicines Agency has established the conditions for the reimbursability of the parent of Parp inhibitors indicated in patients with metastatic pancreatic adenocarcinoma who have had no disease progression after at least 16 weeks of a first line of platinum-based chemo

by Health Review

10 February 2026

4' min read

Translated by AI

Versione italiana

4' min read

Translated by AI

Versione italiana

Breakthrough in the treatment of one of the most aggressive cancers, metastatic pancreatic adenocarcinoma. The Italian Medicines Agency (Aifa) has approved the reimbursability of olaparib, the target therapy and progenitor of the Parp inhibitors, for the maintenance treatment of patients with metastatic adenocarcinoma of the pancreas and with mutations in the Brca1/2 germline, who have not experienced disease progression after a minimum of 16 weeks of platinum-based treatment in a first-line chemotherapy regimen. In 2024, 13,585 new cases of pancreatic cancer are estimated to occur in Italy. Approximately 7% have the Brca1/2 gene mutation. In this patient population, olaparib showed a 47% reduction in the risk of disease progression in the Polo study.

The Studio

'Metastatic pancreatic adenocarcinoma is one of the neoplasms with the worst prognosis, characterised by a late diagnosis, an extremely rapid clinical course, and a considerable impact on patients' quality of life,' explains Michele Reni, Director of Medical Oncology at Irccs Ospedale San Raffaele in Milan and Associate Professor of Oncology at the Vita-Salute San Raffaele University. The international phase III Polo study, published in the New England Journal of Medicine, involved 154 patients with adenocarcinoma of the pancreas with germline mutation in the Brca1/2 genes, who had received first-line chemotherapy with platinum derivatives for at least 16 weeks without disease progression. Progression-free survival almost doubled with olaparib and reached 7.4 months compared to 3.8 months with placebo. A statistically significant result, as no maintenance treatment in pancreatic cancer had improved progression-free survival to date. Not only that. Three-year survival was 33.9% for olaparib compared to 17.8% with placebo.

'Polo is the first study that, in pancreatic carcinoma, has established an advantage with a molecular-targeted drug on the basis of a genetic mutation,' continues Prof. Reni, who is one of the study's authors. 'This opens up, even in this disease, thanks to Aifa's approval of olaparib's reimbursability, a path already successfully followed in other malignancies, in which patients receive therapies based on mutations in the gene-molecular profile.

The disease

Pancreatic cancer is one of the most difficult to treat and complex to diagnose. No screening tests are available and the disease usually manifests itself with late symptoms, when it has already spread. Only 20% of cases are diagnosed at an early stage, when surgery can still lead to a cure. Despite improvements in chemotherapy and supportive therapies, the prognosis of pancreatic adenocarcinoma remains among the worst among solid tumours.

"The management of advanced pancreatic adenocarcinoma has been based for decades on chemotherapy, with a significant toxicity burden for prolonged treatments and relatively few options for patients who no longer responded to the first line of treatment," says Michele Milella, Director of Oncology at the Azienda Ospedaliera Universitaria Integrata di Verona. Therefore, scientific research has focused on identifying the molecular targets at the basis of the disease, such as the Brca genes, which increase the risk of developing not only breast, ovary and prostate neoplasms, but also pancreatic ones'.

real world data

Data from an independent real-world study in Italy, published in 'Cancer Medicine', have led to the long-awaited approval of olaparib's reimbursability. "The survey involved 23 oncology departments distributed throughout Italy and included 114 patients," emphasises Prof. Milella, first author of the study published in 'Cancer Medicine'. The aim of the study was to collect real-world data to assess whether the use of olaparib, both in first-line maintenance as per the approved indication and in more advanced lines of therapy, was associated with a significant and clinically relevant prolongation of overall survival in patients with metastatic pancreatic adenocarcinoma carrying Brca1/2 mutations. In patients who received olaparib in any line of treatment, including maintenance therapy in the absence of progression after chemotherapy, as in the POLO study, the greatest overall survival benefit was demonstrated, with a 43% reduction in the risk of death. These data confirm, in daily clinical practice, the value of the drug that had already emerged in the registration study'.

'Aifa's approval of the reimbursability of olaparib is a decisive step forward in the treatment of this tumour and highlights the centrality of the Brca mutation test, which must be guaranteed to all patients at the time of diagnosis,' Prof. Reni concludes. A positive Brca test in a newly diagnosed patient conditions not only the choice of therapy, i.e. platinum-based chemotherapy followed by olaparib, but also, as a cascade, makes it possible to promptly identify family members who are carriers of the same mutation, including them, if necessary, in prevention and surveillance programmes for the various neoplasms that can develop as a consequence of a mutation in the Brca genes'.

A strategic partnership

In July 2017, AstraZeneca and Merck, known as MSD outside the US and Canada, announced a global strategic collaboration in oncology to co-develop and co-market olaparib, the world's first Parp inhibitor for several cancer types. Working together, the companies will develop olaparib and other potential new drugs as monotherapies and combinations. Independently, the companies will develop olaparib in combination with their respective PD-L1 and PD-1 drugs.