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Immunotherapy continues to transform the management of bladder cancer, one of the most challenging in advanced forms. A new study presented at the ESMO Congress found that a combination of Imfinzi and chemotherapy reduced the risk of recurrence by 32% and the risk of death by 25%. These findings could lead to a change in standard treatment.
Study finds immunotherapy combined with chemotherapy significantly reduces risk of recurrence and death in bladder cancer patients.
Advanced bladder cancer: frequent recurrences
Bladder cancer is the 9th most common cancer worldwide, with more than 614,000 patients diagnosed each year. The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract. MIBC, so named because it grows in the muscular wall of the bladder, accounts for about a quarter of all bladder cancer cases.
“Bladder cancer is mostly diagnosed at a localized stage, with however around 25% of tumors being said to be infiltrating, with involvement of the bladder muscle (MIBC). The standard treatment in this situation is neoadjuvant chemotherapy (before surgery for patients able to receive it, then in most cases, bladder removal associated with lymph node dissection. In some selected cases, post-operative immunotherapy may also be offered. Despite these treatments, the risk of relapse and death remains high, often greater than 30% within 3 years.” explains Dr Delphine Borchiellini, medical oncologist at the Antoine Lacassagne Center.
This shows how much doctors are waiting for the arrival of new treatments.
A significant reduction in the risk of recurrence and death
The trial, presented at the European Society for Medical Oncology (ESMO) 2024 Annual Meeting, compared the efficacy of durvalumab (Imfinzi) plus neoadjuvant chemotherapy (given before surgery) to chemotherapy alone in more than 1,000 patients in 22 countries. Patients were treated with Imfinzi before and after surgery, a new treatment approach known as perioperative. This strategy not only better targeted cancer cells before surgery, but also boosted the patient’s immune defense after surgery, thereby reducing the risk of recurrence.
The results are impressive: Imfinzi reduced the risk of recurrence by 32% and the risk of death by 25% compared with neoadjuvant chemotherapy alone. These results could well change the way bladder cancer is treated in the future. 82.2% of patients treated with the Imfinzi (durvalumab) regimen were alive at two years, compared with 75.2% in the control arm. Imfinzi (durvalumab) was generally well tolerated and no new safety concerns were observed in the neoadjuvant and adjuvant settings. Grade 3 and 4 adverse events of any cause occurred in 69% of patients treated with Imfinzi and in 68% of patients treated with neoadjuvant chemotherapy.
Towards a change in standard treatment
In light of these results, Imfinzi could become a standard treatment for MIBC, offering a new perspective to thousands of patients around the world. Professor Thomas Powles, oncologist and lead investigator of the study, said: “The addition of durvalumab before and after surgery significantly reduced the risk of recurrence and prolonged survival, a significant advance that has the potential to transform the standard of care for these patients who desperately need better outcomes.“.
Like him, many experts believe that this combined treatment could become the standard in the perioperative management of MIBC.”In this context, the NIAGARA study would allow us to rethink the management. This is the first phase III study to show the survival benefit of immunotherapy combined with neoadjuvant chemotherapy, followed by systematic postoperative immunotherapy for patients with a muscle-invasive bladder tumor. Finally, what is important to note for patients is that Imfinzi (durvalumab) has shown good tolerance in this perioperative setting, with well-known and manageable side effects.” enthuses Dr. Borchiellini. Discussions are already underway for the approval of this therapy in Europe and the United States.