Mabwell (Shanghai) Bioscience Co., Ltd. (Mabwell; stock name: MABWELL-B) released updated clinical results for its Nectin-4-targeting antibody-drug conjugate 9MW2821 (Bulumtatug Fuvedotin, BFv) ahead of its oral and poster presentations at the ESMO Gynaecological Cancers Congress 2026.
Phase I/II Monotherapy Updates • Population: 53 efficacy-evaluable patients with recurrent or metastatic cervical cancer. • Efficacy: Confirmed overall response rate (cORR) reached 32.08%; disease control rate (DCR) was 81.13%. • Survival: Median overall survival (mOS) was 19.40 months; 12- and 24-month overall survival (OS) rates were 72.7% and 49.1%, respectively. Median progression-free survival (mPFS) stood at 3.90 months; median duration of response (mDOR) was 5.98 months. • Heavily pretreated subgroup (n=31; prior platinum doublet + checkpoint inhibitors): cORR 29.00%, DCR 77.40%, mPFS 4.00 months, mDOR 9.10 months, mOS not reached; 12- and 24-month OS rates were 76.6% and 51.1%. • Safety: No new safety signals identified during follow-up.
Phase Ib/II Combination with Toripalimab • Enrollment: 19 patients (3 previously treated; 16 treatment-naïve). • Evaluable cohort: 13 patients showed an ORR of 76.92% (1 CR, 9 PR) and DCR of 100%. • Treatment-naïve subset: ORR reached 80.00% (8 of 10 patients). • Adverse events were mainly Grade 1–2, with no novel safety findings.
Broader Development Program 9MW2821 is Mabwell’s first site-specific conjugated ADC developed via its proprietary platform. The candidate is under evaluation across more than 2,000 subjects in multiple tumor types: urothelial carcinoma (UC), cervical cancer (CC), esophageal carcinoma (EC) and triple-negative breast cancer (TNBC). Key initiatives include: 1. Four ongoing Phase III registrational trials—UC monotherapy, UC combination, CC monotherapy (first Nectin-4 agent in Phase III for CC) and TNBC monotherapy post-topoisomerase ADC. 2. Additional Phase I/II studies covering U.S. and China cohorts in TNBC, UC and EC, including combination and perioperative settings. Interim analyses for the three Phase III studies (UC monotherapy, UC combo, CC monotherapy) are scheduled for 2026, with pre-NDA discussions planned with China’s Center for Drug Evaluation.
Risk Considerations Mabwell reiterates that clinical success and regulatory approvals are subject to inherent uncertainties in drug development. The company commits to timely disclosure of material developments as trials progress.
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