390,000 cancer diagnoses. This is the estimate of the number of new cases of cancer in Italy in 2025. A series of conditions that pose complex treatment challenges to be implemented on a case-by-case basis by combining different therapeutic strategies, from surgery to medical therapies such as chemotherapy and intelligent drugs, up to radiotherapy and immunotherapy. On this last front, there is growing evidence of how much and how immunotherapy drugs can “teach” the body to defend itself. It is in this context that four new indications approved by the Italian Medicines Agency (AIFA) were recently presented for a drug, durvalumab, as part of an event organized by AstraZeneca held in Milan.
Research and immunotherapy
The immune system can be compared to an extraordinary and extremely complicated orchestra, made up of at least 4,000 billion different components. Not all the orchestral pieces, instruments and scores of the immunological orchestra are known. This is why research must proceed. Because every step forward in this understanding translates into benefits for patients.
The parallel with music comes from Alberto Mantovani, President of the Humanitas Foundation for Research and Professor Emeritus at Humanitas University, who explains: “at the beginning of the new Millennium, we witnessed a paradigm shift, which led to a new vision of cancer, no longer as a disease centered only on the tumor cell, but also characterized by the microenvironment, that is, the ecological niche in which the neoplasm develops and of which some cells of the immune system, such as macrophages and T cells, are part of The new vision has been accompanied by the discovery of the immune system’s brakes, the so-called checkpoints, and the consequent development of drugs capable of releasing the immune response. Cancer has the ability to deceive and disorient the cells of the immune system, developing inappropriate inflammatory responses.
What’s new in treatments
In 2025, in Italy, 43,500 new cases of lung cancer were estimated, the second most frequent neoplasm after breast cancer. AIFA has approved the reimbursement of durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment (before surgery) followed by durvalumab monotherapy as adjuvant treatment (after surgery), in patients with resectable non-small cell lung cancer at high risk of recurrence and in the absence of EGFR mutations or ALK rearrangements.
Another very frequent neoplasm in which the perioperative regimen with durvalumab has shown benefits is that of the bladder, which has led to an estimated 29,100 new diagnoses in Italy in 2025. AIFA has approved the reimbursement of durvalumab in association with chemotherapy (gemcitabine and cisplatin) as a neoadjuvant treatment, i.e. before radical cystectomy (complete surgical removal of the bladder), followed by durvalumab as adjuvant monotherapy in patients with resectable muscle-invasive bladder cancer.
Another form of neoplasm, for which there has been no progress for over 40 years, is limited-stage small cell lung cancer. AIFA has approved the reimbursement of durvalumab as monotherapy for the treatment of patients with limited-stage small cell lung cancer, whose disease has not progressed following platinum-based chemoradiotherapy. Finally, immunotherapy is also making important progress in the most frequent gynecological neoplasia, that of the endometrium, with 8,260 new cases estimated in Italy in 2025. AIFA has approved durvalumab in association with chemotherapy (carboplatin and paclitaxel) in the first-line treatment of patients with advanced or relapsed primary endometrial carcinoma with mismatch repair deficiency (dMMR), who are candidates for systemic therapy, followed by maintenance treatment with durvalumab monotherapy.
