The single-arm, phase 2 SAKK 06/17 trial analyzed the addition of neoadjuvant durvalumab to gemcitabine/cisplatin chemotherapy in patients with muscle-invasive bladder cancer (MIBC) followed by radical surgery and adjuvant checkpoint inhibition with durvalumab.
The study analyzed 54 cisplatin-fit patients with stage cT2-T4a cN0-1 operable MIBC from 12 treatment sites. Patients were administered 4 cycles of neoadjuvant gemcitabine/cisplatin combined with 4 cycles of durvalumab (starting at the second gemcitabine/cisplatin cycle) followed by radical surgery. Adjuvant durvalumab was administered for 10 cycles. The primary end point was event-free survival (EFS) at 2 years.
The median follow-up was 40 months. The primary end point was met, with an EFS at 2 years of 76% (one-sided 90% CI [lower bound], 67%; two-sided 95% CI, 62-85). EFS at 3 years was 73% (95% CI, 59-83). Complete pathologic response in resected patients (n=52) was achieved in 17 patients (33%), and 31 (60%) had pathologic response <ypT2 ypN0.
Overall survival (OS) was 85% (95% CI, 72-92) at 2 years and 81% (95% CI, 67-89) at 3 years. Grade 3 and 4 treatment-related adverse events (TRAEs) during neoadjuvant treatment occurred in 42% and 25% of patients, respectively. Grade 3 TRAEs related to adjuvant durvalumab occurred in 5 (11%) patients, and grade 4 TRAEs occurred in 2 (4%).
Adding perioperative durvalumab to the standard-of-care treatment of gemcitabine/cisplatin in patients with resectable MIBC resulted in high EFS and OS at 2 years.