Abstract
Bladder cancer (BC) is the most common malignancy of the genitourinary tract, with high morbidity and mortality rates. Until recently, the treatment of locally advanced or metastatic urothelial BC was based on the use of chemotherapy alone. Since 2016, five immune checkpoint inhibitors (ICIs) have been approved by the Food and Drug Administration (FDA) in different settings, i.e., first-line, maintenance and second-line treatment, while several trials are still ongoing in the perioperative context. Lately, pembrolizumab, a programmed death-1 (PD-1) inhibitor, has been approved for Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC), using immunotherapy at an early stage of the disease. This review investigates the current state and future perspectives of immunotherapy in BC, focusing on the rationale and results of combining immunotherapy with other therapeutic strategies.
Highlights
Bladder cancer (BC) is the ninth-most common malignancy worldwide, with 83,730 estimated new cases in the USA in 2021 [1] and the seventh-most common cancer in men [2]
This study considered durvalumab plus olaparib in patients with cT2-T4a N0 M0 urothelial carcinoma, demonstrating a pathological complete response (pCR) rate of 44.5%, and grade 3–4 adverse events (AEs) in 8.3% of patients [42]
With regard to progression free survival (PFS), the IMvigor130 trial showed the advantage of combined chemoimmunotherapy over chemotherapy alone (8.2 months vs. 6.3 months; HR, 0.82; 95% CI, 0.70–0.96; p = 0.007), while no statistically significant benefit on overall survival (OS) was seen at the interim analysis after a median follow-up of 11.8 months [64]
Summary
Bladder cancer (BC) is the ninth-most common malignancy worldwide, with 83,730 estimated new cases in the USA in 2021 [1] and the seventh-most common cancer in men [2]. Following the presentation of these data, pembrolizumab received FDA approval in January 2020 for BCG-unresponsive high-risk NMIBC patients, ineligible for, or refusing RC. At the 2021 ASCO Genitourinary Cancers Symposium, Balar et al reported additional results with an extended minimum follow-up of 26.3 months [31] Among those patients achieving CR, 33.3% remained in CR for ≥18 months and 23.1% for ≥24 months as of the data cutoff date. Not applicable (N/A); number (No.); metastatic urothelial cancer (mUC); metastatic bladder cancer (mBC); standard of care (SoC); best supportive care (BSC); overall survival (OS); progression free survival (PFS); disease free survival (DFS); events free survival (EFS); pathological complete response (pCR); radical cystectomy and pelvic lymph node dissection (RC-PLND); muscle-invasive bladder cancer (MIBC). In early phase clinical trials, perioperative ICI strategies have shown encouraging outcomes, results of phase III randomized controlled trials are eagerly awaited, and sensitive biomarkers are needed to support treatment decision
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