COPENHAGEN, Denmark, June 18, 2026
Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, has unveiled encouraging clinical data for its Nectin-4-targeting antibody-drug conjugate (ADC) 9MW2821 (Bulumtatug Fuvedotin, BFv) at the 2026 ESMO Gynaecological Cancers Congress. The company presented results from two clinical studies evaluating the investigational therapy in patients with recurrent or metastatic cervical cancer, demonstrating a manageable safety profile and promising efficacy outcomes. The findings highlight the potential of 9MW2821 as both a monotherapy and in combination with the PD-1 inhibitor Toripalimab, offering new hope for patients who have progressed after standard treatments. The data further strengthen Mabwell’s position in the rapidly expanding ADC market and reinforce the growing role of targeted therapies in addressing significant unmet needs in gynecologic oncology.
9MW2821 Demonstrates Durable Survival Benefits in Cervical Cancer
During an oral presentation delivered by researchers from Fudan University Shanghai Cancer Center, updated results from the Phase I/II study evaluating 9MW2821 in recurrent or metastatic cervical cancer showed encouraging long-term clinical outcomes. The study enrolled patients whose disease had progressed following platinum-based chemotherapy, including many who had previously received bevacizumab and immune checkpoint inhibitors. Among efficacy-evaluable patients, the therapy achieved a confirmed objective response rate (cORR) of 32.08% and a disease control rate (DCR) of 81.13%, while delivering a median overall survival of 19.4 months.
Particularly noteworthy were the results in patients previously treated with immunotherapy, where the 24-month overall survival rate reached 51.1%, demonstrating meaningful durability of response in a difficult-to-treat population. Researchers reported no new safety concerns during follow-up, further supporting the potential of 9MW2821 as a promising therapeutic option for advanced cervical cancer patients with limited treatment alternatives.
Combination Strategy With Toripalimab Delivers High Response Rates
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Mabwell also presented data from a Phase Ib/II study investigating 9MW2821 in combination with the PD-1 inhibitor Toripalimab. The study enrolled both previously treated and treatment-naïve patients with recurrent or metastatic cervical cancer and aimed to evaluate safety and preliminary efficacy. Among patients evaluable for efficacy, the combination achieved an impressive objective response rate of 76.9%, including one complete response and nine partial responses, while the disease control rate reached 100%.
In treatment-naïve patients, the objective response rate increased to 80.0%, highlighting the potential of the combination as a future frontline treatment strategy. Importantly, treatment-related adverse events were predominantly Grade 1 or Grade 2 in severity, and investigators observed no unexpected safety signals. These findings suggest a strong synergistic effect between the Nectin-4-targeting ADC and immune checkpoint inhibition, potentially opening a new therapeutic pathway for patients with advanced cervical cancer.
Phase III Development Expands Across Multiple Cancer Indications
The latest results add momentum to Mabwell’s broader clinical development program for 9MW2821, which is currently being evaluated across multiple solid tumor indications, including urothelial carcinoma, cervical cancer, esophageal cancer, and breast cancer. The investigational ADC has already achieved several important regulatory milestones, including FDA Fast Track Designation for three indications, Orphan Drug Designation, and Breakthrough Therapy Designation from China’s National Medical Products Administration.
Notably, 9MW2821 has become the world’s first Nectin-4-targeting ADC to enter Phase III clinical trials for cervical cancer and triple-negative breast cancer, underscoring its significance within the oncology landscape. Mabwell currently has four pivotal Phase III studies underway and plans interim analyses for cervical cancer and urothelial carcinoma programs during 2026. Positive outcomes from these studies could support future regulatory submissions and accelerate the availability of a novel targeted therapy designed to improve outcomes for patients with difficult-to-treat cancers worldwide.
Source: Mabwell press release
