Mabwell presented 2 latest clinical study results of its independently developed Nectin-4-targeting ADC 9MW2821 (Bulumtatug Fuvedotin, BFv) in cervical cancer at the European Society for Medical Oncology Gynecological Cancers Congress 2026 (ESMO Gynae 2026) in Copenhagen, Denmark, held June 17-19, 2026. The 2 studies demonstrated that 9MW2821 has a manageable safety profile and promising therapeutic effects in patients with cervical cancer, with particularly notable survival benefits observed in immunotherapy-pre-treated patients. The combination of 9MW821 with a PD-1 inhibitor showed encouraging antitumor activity in advanced cervical cancer.

The phase 1/2 cervical cancer cohort of this clinical study (NCT05216965) enrolled patients with recurrent or metastatic Cervical Cancer (r/m CC) who had progressed on or after platinum-based chemotherapy with or without bevacizumab and received no more than 2 previous systemic regimens for recurrent or metastatic disease. Subjects received 1.25 mg/kg of BFv by intravenous infusion on days 1, 8, and 15 each 28-day cycle.

As of March 20, 2025, 55 patients were enrolled. Of these, 49.09 percent patients had received prior platinum-based doublet chemotherapy plus bevacizumab, and 58.18 percent had received prior platinum-based doublet chemotherapy plus immune checkpoint inhibitors.

Among the 53 patients evaluable for efficacy, the confirmed Objective Response Rate (cORR) and Disease Control Rate (DCR) were 32.08 percent and 81.13 percent, respectively, with 1 complete response (1.87 percent) and 17 partial responses (30.19 percent). Median Progression-Free Survival (mPFS) was 3.9 months and median Duration of Response (mDOR) was 5.98 months. Median Overall Survival (mOS) was 19.4 months, with a 12-month OS rate of 72.7 percent and a 24-month OS rate of 49.1 percent.

Among the 31 post-IO patients evaluable for efficacy, cORR and DCR were 29 percent and 77.40 percent, respectively. Median PFS was 4.0 months and median DoR was 9.1 months. Median OS has not yet been reached. The 12-month OS rate was 76.6 percent and the 24-month OS rate was 51.1 percent. No new safety signals were observed in this follow-up.