Bulumtatug fuvedotin

China-based Mabwell (688062.SH, 02493.HK) reported early-stage clinical data for its Nectin-4-targeting antibody-drug conjugate 9MW2821 (bulumtatug fuvedotin, BFv) in cervical cancer at the ESMO Gynaecological Cancers Congress in Copenhagen, with results that position the molecule as a potential competitor to Pfizer’s Tivdak (tisotumab vedotin) in the post-platinum setting — and, more ambitiously, as a first-line combination option if later-stage data hold. The monotherapy arm of NCT05216965, a Phase I/II study in recurrent or metastatic cervical cancer, enrolled 55 patients who had progressed on platinum-based chemotherapy with or without bevacizumab. Among 53 efficacy-evaluable patients, the confirmed objective response rate (cORR) was 32% and the disease control rate reached 81%. The headline survival figure — a median overall survival of 19.4 months, with a 24-month OS rate of 49% — is notable for a heavily pretreated population, though the single-arm design and modest sample size preclude direct comparison with approved agents. Cross-trial comparisons are limited, but tisotumab vedotin’s Phase III innovaTV 301 trial, which supported full FDA approval in April 2024, reported a median OS of approximately 11.5 months versus 9.5 months for chemotherapy in a similar post-platinum population. Combination data draw more attention A second potentially commercially significant dataset came from a Phase Ib/II study pairing BFv with Junshi Biosciences’ Loqtorzi (toripalimab), a PD-1 inhibitor approved by the US FDA for nasopharyngeal carcinoma but not for cervical cancer. Among 13 efficacy-evaluable patients — a very small cohort — the ORR was 77% and the disease control rate reached 100%. In the 10 treatment-naïve patients evaluable for response, the ORR was 80%. Adverse events were predominantly Grade 1–2, with no new safety signals identified. These numbers, while preliminary, are relevant because the first-line cervical cancer setting is currently anchored by Merck’s Keytruda (pembrolizumab) combined with platinum-based chemotherapy with or without Roche’s Avastin (bevacizumab), an approach restricted to patients with PD-L1 CPS ≥1. A chemotherapy-free ADC plus PD-1 combination that could demonstrate durable responses regardless of biomarker status would address a genuine gap — though the 13-patient efficacy dataset reported here is far too small to draw conclusions about clinical positioning. Strategic context Mabwell describes 9MW2821 as the first Nectin-4-directed ADC to enter Phase III trials for both cervical cancer and triple-negative breast cancer. Four pivotal Phase III studies are currently under way, with interim analyses for urothelial carcinoma monotherapy, urothelial carcinoma combination therapy, and cervical cancer monotherapy all planned for 2026. The company has secured FDA Fast Track Designation for three indications and Breakthrough Therapy Designation from China’s National Medical Products Administration for two indications. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

SHANGHAI, June 18, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, presented two 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 Gynaecological Cancers Congress 2026 (ESMO Gynae 2026) in Copenhagen, Denmark, held June 17–19, 2026. The two 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-pretreated patients. The combination of 9MW2821 with a PD-1 inhibitor showed encouraging antitumor activity in advanced cervical cancer. Continue Reading Prof. Yang Huijuan from Fudan University Shanghai Cancer Center delivered an in-depth oral presentation on behalf of the research team. Oral Presentation: BFv in Recurrent or Metastatic Cervical Cancer The Phase I/II 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% patients had received prior platinum-based doublet chemotherapy plus bevacizumab, and 58.18% 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% and 81.13%, respectively, with 1 complete response (1.87%) and 17 partial responses (30.19%). 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% and a 24-month OS rate of 49.1%. Among the 31 post-IO patients evaluable for efficacy, cORR and DCR were 29.00% and 77.40%, 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% and the 24-month OS rate was 51.1%. No new safety signals were observed in this follow-up. Poster Presentation: BFv in Combination with Toripalimab for Recurrent or Metastatic Cervical Cancer The study consists of a phase lb safety run-in followed by a phase lI cohort expansion, enrolling patients with cervical cancer who had received ≥ 1 line therapy (Phase lb), and who had no prior systemic chemotherapy (Phase ll). Patients received BFv 1.25mg/kg on days 1, 8 and Toripalimab at 240mg on day 1 of each 21-days cycle. The primary endpoints were safety and preliminary efficacy. As of March 19, 2026, a total of 19 patients were enrolled, including 3 previously treated patients and 16 treatment-naïve patients. The mean patient age was 57.8 years, and 89.5% had squamous cell carcinoma. 13 patients were evaluable for efficacy with at least one post-baseline tumor assessment. The ORR was 76.9% (10/13), including 1 complete response (CR) and 9 partial responses (PR), and the DCR was 100%. In treatment-naïve patients, the ORR reached 80.0% (8/10). Treatment-related adverse events (TRAEs) were primarily Grade 1–2, and no new safety signals were observed. The preliminary findings demonstrate a synergistic effect of the Nectin-4-targeting ADC combined with a PD-1 inhibitor in the treatment of cervical cancer, and also offer the potential to establish a new first-line therapy for patients with recurrent or metastatic cervical cancer. About 9MW2821 (BFv) 9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell based on its ADC development platform. It is the world's first Nectin-4 ADC to enter Phase III clinical trials for cervical cancer (CC) and triple-negative breast cancer (TNBC). Four pivotal Phase III clinical studies are underway. 9MW2821 has obtained FDA Fast Track Designation for three indications, Orphan Drug Designation for one indication, and Breakthrough Therapy Designation from the CDE of NMPA for two indications. Interim analysis for the Phase III clinical trials of urothelial carcinoma (UC) monotherapy, UC combination therapy and CC monotherapy are planned to be conducted in 2026, and Applications for pre-NDA meetings are expected to be submitted to the Center for Drug Evaluation under the National Medical Products Administration based on the data of interim analysis. About Mabwell Mabwell (688062.SH, 02493.HK) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company is committed to providing more effective and accessible therapies to meet global medical needs, with a focus on oncology and aging-related diseases. Mabwell's mission is "Explore Life, Benefit Health" and its vision is "Innovation, from Ideas to Reality." For more information, please visit . 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