bulumtatug fuvedotin (9MW2821) / Mabwell (Shanghai) Biosci - LARVOL DELTA

Bulumtatug Fuvedotin (BFv, 9MW2821), a Nectin-4–Directed Antibody-Drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Triple Negative Breast Cancer (la/mTNBC) Previously Treated with Topoisomerase I Inhibitor (TopI)-Based ADCs: Results from a Phase 2 Study (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study. (ASCO 2024) - P1/2 | "The data indicated encouraging efficacy of 9MW2821 in advanced UC, CC, EC and TNBC. 9MW2821 is the first Nectin-4 targeting ADC showed antitumor activity in patients with CC, EC and TNBC. The safety profile showed adequate tolerability."

Clinical • Metastases • P1/2 data • Alopecia • Anemia • Breast Cancer • Cervical Cancer • Constipation • Diabetes • Dyslipidemia • Esophageal Cancer • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Disorders • Hypertriglyceridemia • Immunology • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • NECTIN4

Beyond approval: a mechanism-based review of novel anti-tumour agents in cervical cancer and when to use them. (PubMed, Front Immunol) - "Cervical cancer remains a leading cause of cancer death in women, and outcomes in recurrent or metastatic disease remain poor despite chemoradiation and bevacizumab...We cover immune checkpoint inhibitors, bispecific antibodies, antibody-drug conjugates (ADCs), therapeutic HPV vaccines and adoptive cell therapy, and integrate China-developed agents-including the PD-1/CTLA-4 bispecific cadonilimab and the Nectin-4 conjugate 9MW2821-into the global landscape...We further argue that, because access to newly approved agents varies widely between health systems, the line of therapy at which an agent is introduced-rather than its approval status alone-may influence survival, a decision-relevant question that current guidelines leave unanswered. This mechanism-based, decision-oriented synthesis is intended to guide rational agent selection, sequencing and combination strategy across diverse clinical settings."

IO biomarker • Journal • Review • Cervical Cancer • Oncology • Solid Tumor • NECTIN4 • PD-1

Bulumtatug fuvedotin (BFv, 9MW2821), a nectin-4 antibody-drug conjugate, in patients with recurrent or metastatic cervical cancer: Updated results from a phase I/II study (ESMO-Gynae 2026) - P1/2 | "This cervical cancer cohort enrolled patients with recurrent or metastatic cervical cancer (CC) who had progressed on or after doublet platinum-containing chemotherapy with or without bevacizumab and received no more than two previous systemic regimens for recurrent or metastatic disease. Conclusions Updated OS data continue to show encouraging efficacy and manageable tolerance of BFv in CC, especially in post-IO pts. A phase III confirmatory trial of BFv or chemotherapy in patients with CC is ongoing."

ADC • Clinical • Metastases • P1/2 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor • NECTIN4

9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study. (ASCO 2025) - P1/2, P3 | "9MW2821 combined with Toripalimab in treatment-naïve patients with la/mUC demonstrated remarkable efficacy and well-tolerated safety profile. A pivotal phase 3 study is ongoing currently. Clinical trial identification: NCT06592326."

Clinical • Metastases • P1/2 data • Bladder Cancer • Breast Cancer • Cervical Cancer • Esophageal Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Follow-up results from a phase 1b/2 study. (ASCO 2026) - P1/2, P3 | "BFv plus toripalimab in patients with la/mUC demonstrated remarkable efficacy and well-tolerated safety profile. A pivotal phase 3 study is ongoing currently. Clinical trial identification: NCT06592326."

Clinical • Metastases • P1/2 data • Breast Cancer • Cervical Cancer • Esophageal Cancer • Oncology • Solid Tumor • Urothelial Cancer

9MW2821, a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study. (PubMed, Ann Oncol) - P1/2, P3 | "The results suggest that 9MW2821 was tolerable and clinically significant in efficacy in various types of solid tumors besides urothelial cancer. Several pivotal trials are currently in progress. (NCT06196736, NCT06592326, NCT06692166)."

Clinical • Journal • P1 data • Breast Cancer • Cervical Cancer • Esophageal Cancer • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Pain • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • NECTIN4

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2028 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

ESMO 2026 | Mabwell to Present Latest Clinical Data on Nectin-4-targeting ADC 9MW2821 for Triple Negative Breast Cancer in Oral Presentation (PRNewswire) - "

P2 data • Triple Negative Breast Cancer

Preliminary results of bulumtatug fuvedotin (BFv, 9MW2821) in combined with toripalimab in patients with recurrent or metastatic cervical cancer: A cohort from a phase Ib/II clinical study (ESMO-Gynae 2026) - "Conclusions This combination therapy demonstrated a manageable safety profile and encouraging antitumor activity in r/m CC patients. Enrollment for this study is ongoing, and further data are warranted to confirm these findings."

Clinical • Metastases • P1/2 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Poster Presentation: BFv in Combination with Toripalimab for Recurrent or Metastatic Cervical Cancer (PRNewswire) - "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."

P1/2 data • Cervical Cancer • Squamous Cell Carcinoma

Oral Presentation: BFv in Recurrent or Metastatic Cervical Cancer (PRNewswire) - "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."

P1/2 data • Cervical Cancer

CVL006-T1003: Clinical Study of CVL006 Combination With 9MW2821 (clinicaltrials.gov) - P1/2 | N=108 | Not yet recruiting | Sponsor: Convalife (Shanghai) Co., Ltd.

New P1/2 trial • Head and Neck Cancer • Oncology • Parotid Gland Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NECTIN4

Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in perioperative patients with muscle-invasive bladder cancer (MIBC): Results of cohort A from a phase 2 study. (ASCO 2026) - P2 | "Perioperative treatment, especially cisplatin-based neoadjuvant therapy, could reduce the risk of tumor recurrence effectively and prolong the survival of patients. This study showed remarkable preliminary efficacy of BFv plus toripalimab in perioperative patients with MIBC. It may offer a new choice for MIBC patients and deserve to be further investigation."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Mabwell…will present multiple clinical study results of its novel Nectin-4-targeting ADC 9MW2821 (Bulumtatug Fuvedotin, BFv) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, including the Phase Ib/II clinical study data of 9MW2821 in combination with toripalimab for locally advanced or metastatic urothelial carcinoma (la/mUC)… (PRNewswire) - "Follow-up results showed that as of December 1, 2025, 47 subjects were included in the efficacy analysis. The overall objective response rate (ORR) was 83.0%, confirmed ORR was 74.5%, complete response (CR) rate was 12.8%, and disease control rate (DCR) was 89.4%; and for the previously untreated populations, ORR was 87.5%, confirmed ORR was 80.0%, CR rate was 12.5% and DCR was 92.5%. The median progression-free survival (PFS) was 12.9 months, median duration of response (DoR) and median overall survival (OS) was not yet reached. No new safety signals related to 9MW2821 or toripalimab were observed in this study."

P1/2 data • Urothelial Cancer

Mabwell…will present multiple clinical study results of its novel Nectin-4-targeting ADC 9MW2821 (Bulumtatug Fuvedotin, BFv) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, including…the Phase II clinical study data of 9MW2821 in combination with toripalimab for perioperative muscle-invasive bladder cancer (MIBC) (PRNewswire) - "As of January 4, 2026, 7 subjects completed neoadjuvant therapy (9MW2821 in combination with toripalimab). Among these subjects, 6 subjects completed radical cystectomy and regional lymph node dissection, and 1 subject refused radical surgery due to achieving clinical CR following neoadjuvant therapy. Pathological complete response (pCR) was 66.7% (4/6), and pathological downstaging (pDS) rate was 83.3% (5/6). No new safety signals related to 9MW2821 or toripalimab were observed in this study."

P2 data • Bladder Cancer

Efficacy and safety of antibody-drug conjugate based therapy in locally advanced or metastatic urothelial carcinoma: a systematic review and network meta-analysis of emerging clinical evidence. (PubMed, Front Immunol) - "Network meta-analysis showed that, compared with standard therapy, enfortumab vedotin (EV) in combination with pembrolizumab significantly improved OS (HR = 0.63, 95%CI: 0.43-0.92), ORR (OR = 3.33, 95% CI: 1.65-6.74), and PFS (HR = 0.48, 95% CI: 0.41-0.57)...The analysis of single-arm trails revealed that bulumtatug fuvedotin combined with toripalimab achieved an ORR as high as 88% (95% CI: 73%-96%), while disitamab vedotin-based combination therapy showed the longest median OS...The findings confirm the compelling efficacy and manageable safety profile of ADCs in this setting, while also underscoring the need for further clinical trials to validate and refine personalized treatment strategies. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD 420251114022."

Clinical • Journal • Retrospective data • Review • Oncology • Solid Tumor • Urothelial Cancer

2026 ESMO GC | Mabwell to Present Latest Clinical Data on 9MW2821 for Cervical Cancer in Oral and Poster Presentations (The Manila Times)

P1/2 data • Cervical Cancer

A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P3 | N=356 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P3 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Mabwell…announced that two latest clinical study results of its Nectin-4-targeting ADC 9MW2821 in combination with toripalimab for urothelial carcinoma will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (The Manila Times)

P1/2 data • P2 data • Bladder Cancer • Urothelial Cancer

9MW2821 is the world's first Nectin-4 ADC candidate to enter Phase III clinical trials for cervical cancer. (PRNewswire) - "Currently, enrollment for the monotherapy Phase III trial has been completed. Interim analysis is expected to be conducted and pre-NDA to be submitted in H2 2026."

Enrollment closed • FDA event • P3 data • Cervical Cancer

Mabwell…announced that a recent clinical case report on its self-developed novel Nectin-4 ADC (bulumtatug fuvedotin, R&D code: 9MW2821) for the treatment of cervical cancer has been published in The New England Journal of Medicine (NEJM, Impact Factor: 78.5), a leading international medical journal. (PRNewswire) - "This article reports the case of a patient with metastatic cervical squamous-cell carcinoma whose disease was refractory to platinum–taxane chemotherapy with no prior immunotherapy. After just two cycles of treatment with 9MW2821, the patient's baseline metastatic lesions showed substantial regression, and serum squamous cell carcinoma (SCC) antigen levels dropped precipitously—from 37.0 ng/mL to 1.2 ng/mL (normal range ≤1.5). However, despite comprehensive improvement across multiple indicators, a CT scan unexpectedly revealed a 'new hypoattenuating lesion' measuring 1.8 cm × 2.5 cm in the medial segment of the left lobe of the liver...The patient continued treatment, and subsequent imaging showed gradual resolution of the liver lesion, with no reappearance during two years of follow-up."

Case report • Cervical Cancer

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Fudan University | N=120 ➔ 160

Enrollment change • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local UTUC (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Peking University Third Hospital

New P2 trial • Oncology • Solid Tumor • Urothelial Cancer

An open-label, single-center, randomized controlled phase II clinical study evaluating the safety and efficacy of neoadjuvant therapy with radiotherapy plus toripalimab versus 9MW2821 plus toripalimab in patients with upper tract urothelial carcinoma (UTUC) (ChiCTR) - P2 | N=60 | Not yet recruiting | Sponsor: Peking University Third Hospital; Peking University Third Hospital

New P2 trial • Oncology • Solid Tumor • Urothelial Cancer • PD-L1