(UroToday.com) The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting was host to a kidney and bladder cancers poster session. Dr. Zhuowei Liu presented the results of Cohort A from a phase 2 study evaluating bulumtatug fuvedotin (BFv; 9MW2821) + toripalimab in the perioperative setting for patients with muscle-invasive bladder cancer (MIBC).
Radical cystectomy with pelvic lymph node dissection (RC+PLND) remains a standard-of-care option for the treatment of clinically localized MIBC. Cisplatin-based neoadjuvant chemotherapy has been shown to reduce recurrence rates and improve survival outcomes, although many patients remain ineligible for cisplatin or experience disease recurrence despite treatment. BFv is a novel Nectin-4 antibody-drug conjugate that has demonstrated promising activity in advanced urothelial carcinoma when combined with toripalimab, providing rationale for evaluation in the perioperative MIBC setting.
This phase II study enrolled patients with cT2-4aN0-1M0 MIBC into cohort A. Eligible patients underwent the following:
- BFv plus toripalimab for 4 cycles in the neoadjuvant setting
- RC+PLND following neoadjuvant therapy
- BFv plus toripalimab for 6 cycles postoperatively
- Toripalimab monotherapy for an additional 11 adjuvant cycles
The primary endpoint was pathologic complete response (pCR). Secondary endpoints included:
- Pathologic downstaging
- Disease-free survival (DFS)
- Overall survival (OS)
- Safety
As of January 4, 2026:
- 32 patients had been enrolled
- 7 patients completed neoadjuvant therapy
- 6 patients proceeded to RC+PLND
- 1 patient achieved clinical complete response after neoadjuvant therapy and declined surgery
The baseline characteristics are summarized below:
Among the 6 surgically treated patients:
- pCR: 66.7% (4/6)
- Pathologic downstaging: 83.3% (5/6)
DFS and OS data were not yet mature at the time of analysis.
The safety profile was reported to be consistent with prior studies of BFv and toripalimab, with no new safety signals observed.
The investigators concluded that BFv plus toripalimab demonstrated encouraging preliminary efficacy in patients with perioperative MIBC, with high pCR and pathologic downstaging rates observed in this early cohort. These findings support further investigation of this Nectin-4 ADC plus immunotherapy combination as a potential perioperative treatment strategy in MIBC.
Presented by: Zhuowei Liu, Professor, Sun Yat-sen University Cancer Center, Guangzhou, China
Written by: Rashid K. Sayyid, MD, MSc, Assistant Professor, Urologic Oncologist, Department of Urology at The University of Arizona and Banner University Medical Center, Tucson, AZ – @rksayyid on X during the American Society of Clinical Oncology Genitourinary (ASCO) Annual Meeting held in Chicago, IL between May 29th and June 1st, 2026