The trial SAKK 06/17 investigated the integration of immunotherapy together with standard treatment before and after the operation for MIBC. We prove that it is feasible to add the PD-L1 inhibitor durvalumab to neoadjuvant cisplatin/gemcitabine chemotherapy and to continue with adjuvant durvalumab after radical surgery. This approach can achieve high rates of event-free and overall survival at two and three years and is currently being tested in a large randomized phase 3 trial.
Based on our results a follow up trial (SAKK 06/19) is currently running evaluating the addition of intravesical BCG to perioperative chemo-immunotherapy to further boost the immune response and improve outcome.
Full Publication
Journal of Clinical Oncology: Perioperative Chemoimmunotherapy With Durvalumab for Muscle-Invasive Urothelial Carcinoma: Primary Analysis of the Single-Arm Phase II Trial SAKK 06/17