MABWELL-B (ASX: 02493) has announced that it will present the latest clinical data for its innovative Nectin-4-targeting ADC drug, 9MW2821 (Bulumtatug Fuvedotin, BFv), at the 2026 European Society for Medical Oncology Gynaecological Cancers Congress (ESMO Gynae) in Copenhagen, Denmark, from June 17 to 19.
The company will deliver an oral presentation on the updated results from a Phase I/II clinical study of 9MW2821 for treating patients with recurrent or metastatic cervical cancer. Among 53 efficacy-evaluable patients, the median Overall Survival (mOS) was 19.4 months, with a 24-month OS rate of 49.1%. In a subgroup of 31 efficacy-evaluable patients who had received prior platinum-based doublet chemotherapy and immune checkpoint inhibitor therapy, the mOS was not yet reached, and the 24-month OS rate was 51.1%.
Additionally, a poster presentation will showcase preliminary results from one cohort of an Ib/II phase clinical study evaluating 9MW2821 in combination with toripalimab for recurrent or metastatic cervical cancer. In treatment-naïve cervical cancer patients, the Objective Response Rate (ORR) reached 80.0%, with a Disease Control Rate (DCR) of 100%.
About the Drug Candidate
9MW2821 is the company's first site-specifically conjugated ADC drug targeting Nectin-4. It was developed using MABWELL's proprietary ADC platform, featuring a linker with independent intellectual property and an optimized conjugation process for precise antibody modification. After administration, 9MW2821 binds to Nectin-4 on the surface of tumor cells, is internalized, and releases its cytotoxic payload via enzymatic cleavage, enabling precise tumor cell killing.
Ongoing Clinical Program
The company is currently conducting multiple clinical studies across several indications, including urothelial carcinoma (UC), cervical cancer (CC), esophageal carcinoma (EC), and triple-negative breast cancer (TNBC), with over 2,000 subjects enrolled. The program includes four pivotal Phase III registration trials: a UC monotherapy and combination therapy (both designated as Breakthrough Therapies), a CC monotherapy (the first global Phase III candidate for this target in CC), and a TNBC monotherapy for patients previously treated with a topoisomerase inhibitor ADC (the first global candidate for this specific indication).
Several Phase I/II trials are also progressing rapidly. These include a Phase Ib study for TNBC monotherapy (post-topoisomerase inhibitor ADC) in the US, a Phase II study for TNBC combination therapy, a Phase II perioperative combination therapy study for UC, a Phase II monotherapy study for EC, an Ib/II phase combination therapy study for EC, and an Ib/II phase combination therapy study for CC.
Regulatory Pathway and Detailed Data
Interim analyses for the Phase III trials of UC monotherapy, UC combination therapy, and CC monotherapy are planned for 2026. Based on the interim data, the company anticipates requesting a pre-New Drug Application (NDA) meeting with China's Center for Drug Evaluation (CDE).
As of March 20, 2025, among the 53 efficacy-evaluable patients, the confirmed ORR (cORR) was 32.08% and the DCR was 81.13%. The median Progression-Free Survival (mPFS) was 3.9 months, and the median Duration of Response (mDOR) was 5.98 months. The mOS was 19.4 months, with 12-month and 24-month OS rates of 72.7% and 49.1%, respectively.
In the subgroup of 31 patients previously treated with platinum-based chemotherapy and immune checkpoint inhibitors, the cORR was 29.00% and the DCR was 77.40%. The mPFS was 4.0 months and the mDOR was 9.1 months. The mOS was not yet reached, with 12-month and 24-month OS rates of 76.6% and 51.1%, respectively. No new safety signals were observed during this follow-up period.
Combination Therapy Cohort Update
As of March 19, 2026, 19 patients were enrolled in the combination therapy cohort receiving BFv plus toripalimab, comprising 3 previously treated and 16 treatment-naïve patients. Among 13 patients who completed at least one tumor assessment, the ORR was 76.9% (1 Complete Response, 9 Partial Responses) with a DCR of 100%. In the treatment-naïve patients, the ORR reached 80.0% (8 out of 10), indicating a more favorable efficacy trend. Treatment-related adverse events (TRAEs) were predominantly Grade 1-2, with no new safety signals identified overall.
These results preliminarily demonstrate the synergistic potential of combining a Nectin-4-targeting ADC with a PD-1 inhibitor for cervical cancer treatment, potentially opening a new first-line therapeutic pathway for patients with recurrent or metastatic disease.
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