Andrea B. Apolo, MD, discusses ICI therapy in MIBC

In a recent paper published in Cancer, investigators outlined top advances of the year in bladder cancer.¹ One of the advances discussed was adjuvant immune checkpoint inhibition (ICI) treatment in muscle-invasive bladder cancer (MIBC). According to study author Andrea B. Apolo, MD, adjuvant nivolumab (Opdivo) is already an established standard of care for patients with high-risk MIBC following surgery. More recently, the AMBASSADOR trial (NCT03244384 )has shown benefit with pembrolizumab (Keytruda) in the same setting, and National Comprehensive Cancer Network guidelines now recommend both agents. These results underscore the importance of introducing immunotherapy early for patients at high risk of recurrence.

Apolo emphasized the value of having robust monotherapy data before advancing into combination strategies. Adjuvant nivolumab and pembrolizumab monotherapy trials consistently show a disease-free survival benefit and are beginning to trend toward improvements in overall survival, with early data from nivolumab being particularly encouraging. This foundation provides clarity on the contributions of individual agents as the field moves toward testing combination approaches.

One notable next step is the perioperative evaluation of durvalumab (Imfinzi) combined with gemcitabine and cisplatin in the neoadjuvant setting, followed by durvalumab maintenance. As additional regimens enter clinical development, it will be essential to determine whether all patients require intensive multimodality treatment or if therapy can be tailored—some patients receiving only immunotherapy, others chemotherapy, and select patients combinations depending on tumor aggressiveness.

Overall, Apolo noted that MIBC management is evolving rapidly, with the introduction of adjuvant ICI monotherapy marking an important milestone. These findings not only expand treatment options but also lay the groundwork for future strategies that may better personalize therapy, balancing efficacy with the intensity of treatment. The goal is to refine patient selection to maximize benefit while minimizing unnecessary toxicity. Apolo is acting deputy chief of the Genitourinary Malignancies Branch of the National Cancer Institute Center for Cancer Research, head of the Genitourinary Malignancies Branch’s Bladder Cancer Section, and director of the Bladder Cancer and Genitourinary Tumors Multidisciplinary Clinic.

REFERENCE

1. Apolo AB, Saad A, Kydd AR, et al. Top advances of the year: Bladder cancer. Cancer. 2025 Aug 15;131(16):e70020. doi:10.1002/cncr.70020