Clinical Summary:

• Design/Population: A phase 2 study evaluated bulumtatug fuvedotin in patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy. 
• Key Outcomes: Bulumtatug fuvedotin demonstrated durable antitumor activity, including encouraging overall survival, with similar efficacy observed in patients previously treated with immune checkpoint inhibitors.
• Clinical Relevance: These findings support continued development of bulumtatug fuvedotin as a potential treatment option for previously treated recurrent or metastatic cervical cancer.

Updated results from a phase 2 study demonstrated that bulumtatug fuvedotin shows encouraging efficacy and manageable tolerability among patients with recurrent or metastatic cervical cancer, including those previously treated with immune checkpoint inhibitors. 

These findings were presented by Hui Yang, MD, Fudan University Shanghai Cancer Center, Shanghai, China, at the European Society for Medical Oncology (ESMO) Gynecological Cancers Congress in Copenhagen, Denmark. 

In this study, 55 patients with recurrent or metastatic cervical cancer who experienced disease progression on or after platinum-based chemotherapy with or without bevacizumab and received no more than 2 prior lines of systemic therapy for recurrent or metastatic disease received 1.25 mg/kg of bulumtatug fuvedotin on days 1, 8, and 15 of each 28-day cycle. Primary end points included objective response rate (ORR), disease control rate, progression-free survival (PFS), duration of response, and overall survival (OS). A key secondary end point was safety. 

At a median follow-up of 51.3 months, confirmed ORR among 53 efficacy-evaluable patients was 32.1% and the disease control rate was 81.1%. Median PFS was 3.88 months, median duration of response was 5.98 months, and median OS was 19.35 months. 

Among 31 efficacy-evaluable patients who had previously received immunotherapy, confirmed ORR was 29%, and disease control rate was 77.4% . Median PFS was 3.98 months, median duration of response was 9.10 months, and median OS had not yet been reached. 

Safety remained consistent with prior findings and no new safety signals were observed with longer follow-up. 

“Updated OS data continue to show encouraging efficacy and manageable tolerance of [bulumtatug fuvedotin] in [cervical cancer], especially in post-[immunotherapy] pts,” concluded Dr Yang. “A phase 3 confirmatory trial of [bulumtatug fuvedotin] or chemotherapy in patients with [cervical cancer] is ongoing.”

Source:

Yang H, Zhang J, Liu R, et al. Bulumtatug fuvedotin (BFv, 9MW2821), a nectin-4 antibody-drug conjugate, in patients with recurrent or metastatic cervical cancer: Updated results from a phase I/II study. Presented at ESMO Gynecological Cancers Congress. June 17-19, 2026. Copenhagen, Denmark. Abstract 28RO.