Opinion|Videos|October 8, 2025

Andrea B. Apolo, MD, discusses survival gains with EV/pembrolizumab in bladder cancer

Fact checked by: Benjamin P. Saylor

Apolo highlighted the positive topline results from the phase 3 EV-303 trial (NCT03924895) evaluating EV plus pembrolizumab in cisplatin-ineligible patients with muscle-invasive bladder cancer.

In this video, Andrea B. Apolo, MD, discussed how the combination of enfortumab vedotin (EV) and pembrolizumab (Keytruda) has transformed the treatment landscape for advanced bladder cancer. According to Apolo, the regimen has doubled both progression-free and overall survival compared with prior standards, while also achieving response rates of nearly 70%. These impressive results have translated well into clinical practice, offering patients meaningful benefits.

However, she emphasized that effective management of treatment-related toxicities is essential to maintain patient quality of life and treatment continuity. Common overlapping adverse events include dermatologic reactions, such as rashes, which often require multidisciplinary care involving dermatologists or ophthalmologists due to potential ocular manifestations. A unique toxicity linked to enfortumab vedotin is hyperglycemia, while neuropathy—both sensory and motor—represents the primary dose-limiting adverse event.

Apolo underscored the importance of proactive communication and patient reassurance when treatment interruptions or dose reductions are necessary. Holding therapy temporarily or resuming at a reduced dose is a standard and effective approach, not a sign of treatment failure.

Looking ahead, she highlighted the positive topline results from the phase 3 EV-303 trial (NCT03924895) evaluating EV plus pembrolizumab in cisplatin-ineligible patients with muscle-invasive bladder cancer. Although detailed data have not yet been released, Apolo said she anticipates that this combination will move into earlier disease settings, potentially offering curative outcomes. At the same time, she cautioned that expanding use of this potent combination could increase toxicity in patients who might otherwise require less intensive therapy.

As these regimens advance into the muscle-invasive space, Apolo emphasized the need for urologists and oncologists alike to be comfortable managing immune-related and antibody-drug conjugate–related toxicities, with dose adjustment and multidisciplinary collaboration becoming integral to optimal care.

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.

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