Dr Galsky on Neoadjuvant and Adjuvant EV Plus Pembrolizumab in MIBC

“Some of the subgroups were small, and [these data] are always hypothesis generating, but no subgroups seemed to differ in terms of the effect size for EFS or OS.”

Matthew D. Galsky, MD, the deputy director and director of genitourinary medical oncology; codirector of the Center of Excellence for Bladder Cancer; and a professor of medicine, hematology and medical oncology, and urology, at the Mount Sinai Tisch Cancer Center, discussed efficacy data from the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124), which evaluated enfortumab vedotin-ejfv (EV; Padcev) in combination with pembrolizumab (Keytruda) for the perioperative treatment of patients with muscle-invasive bladder cancer (MIBC) who were eligible for cisplatin-containing therapy and radical cystectomy.

Findings presented by Galsky during the 2026 Genitourinary Cancers Symposium revealed that the median event-free survival (EFS) by blinded independent central review of not reached (NR; 95% CI, NR-NR) in patients who received the combination (n = 405) was not reached (NR; 95% CI, NR-NR) compared with 48.5 months (95% CI, 43.3-NR) among patients who received cisplatin plus gemcitabine (n = 403). These data conferred a significant EFS benefit in favor of the investigational arm (HR,0.53; 95% CI, 0.41-0.70; 1-sided P < .0001).

Moreover, the key secondary end points of overall survival (OS) and pathological complete response (pCR) rate were also met, Galsky added. The median OS in both arms was NR (95% CI, NR-NR), and patients who received the combination experienced a 35% reduction in the risk of death compared with those in the control arm (HR, 0.65; (95% CI, 0.48-0.89; 1-sided P = .0029). The respective pCR rates were 55.8% (95% CI, 50.8%-60.7%) and 32.5% (95% CI, 28.0%-37.3%), he concluded.

Disclosures: Galsky holds consulting or advisory roles with Abbvie, Bristol-Myers Squibb, EMD Serono, Gilead Sciences, Janssen, Merck, and Pfizer. He also received research funding from AstraZeneca (Inst), Bristol-Myers Squibb (Inst), Dendreon (Inst), Genentech/Roche (Inst), Janssen Oncology (Inst), Merck (Inst), and Novartis (Inst). He has patents, royalties, or other intellectual property including: METHODS AND COMPOSITIONS FOR TREATING CANCER AND RELATED METHODS. MOUNT SINAI SCHOOL OF MEDICINE July 2012 Application number: 20120322792.