Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer - LARVOL DELTA

Longitudinal ctDNA Profiling in HER2-Altered NSCLC Treated With HER2 Adc: Preliminary Results From the RESOLUTION Trial (IASLC-WCLC 2025) - "A total of 28 eligible patients will receive disitamab vedotin (2.0 mg/kg), tislelizumab (200 mg), and bevacizumab (7.5 mg/kg), all administered intravenously every 3 weeks, until disease progression or unacceptable toxicity. The first-stage interim analysis revealed acceptable efficacy to support proceeding to the further stage. Longitudinal ctDNA analysis enabled dynamic monitoring of tumor burden and early detection of disease progression, underscoring its potential as a non-invasive tool for real-time treatment response assessment."

Circulating tumor DNA • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • HER-2 • TP53

Efficacy and safety results from Formula-01: a phrase II study of Disitamab Vedotin plus BCG in HER2 high expression high-risk non-muscle invasive bladder cancer patients (HR-NMIBC) (ESMO 2025) - No abstract available

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

Disitamab Vedotin plus Tislelizumab as Nephron-Sparing Therapy for High-Risk Upper Tract Urothelial Carcinoma: The Phase II DISTINCT-I Trial (ESMO 2025) - No abstract available

P2 data • Oncology • Solid Tumor • Urothelial Cancer

Antibody-drug conjugates for non-muscle invasive bladder cancer: current status and future development. (PubMed, Curr Opin Urol) - "The findings underscore the potential of ADCs to revolutionize NMIBC management by providing novel bladder-sparing strategies in patients traditionally limited by BCG failure. Future research should concentrate on optimizing patient selection, treatment sequencing, and combination strategies to improve long-term outcomes, enhancing survival and quality of life."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

PUNCH02: Interim results from a phase II study of tislelizumab combined with disitamab vedotin as a bladder preservation therapy for urine tumor DNA (utDNA)-defined clinical complete response (cCR) MIBC patients (ESMO 2025) - No abstract available

Clinical • P2 data • Bladder Cancer • Oncology

Phase 2 study of disitamab vedotin in combination with anlotinib in patients with HER-2 expressing platinum-resistant ovarian cancer. (ESMO 2025) - No abstract available

Clinical • Combination therapy • P2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • HER-2

A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fudan University

New P2 trial • Rare Diseases

DECIDING: A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy as Bladder-preserving Therapy in Patients With Localized HER2-high Expressing Muscle-invasive Bladder Urothelial Carcinoma Following Maximal Transurethral Resection (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: RenJi Hospital

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

Recent advances in antibody-drug conjugates for metastatic castration-resistant prostate cancer. (PubMed, Zhejiang Da Xue Xue Bao Yi Xue Ban) - P3 | "Among prostate-specific membrane antigen (PSMA)-targeted ADCs, ARX517 demonstrates superior safety and more significant prostate-specific antigen (PSA) reductions compared to earlier agents such as MLN2704, PSMA-ADC, and MEDI3726. ADCs targeting B7-H3, such as MGC018 and DB-1311, have also shown antitumor activity. ADCs targeting other antigens, including six-transmembrane epithelial antigen of the prostate (STEAP)1 (DSTP3086S), trophoblast cell surface antigen (TROP)2 (sacituzumab govitecan), and solute carrier (SLC) 44A4 (ASG-5ME), have shown preliminary antitumor activity in early trials but face challenges with insufficient efficacy or toxicity. Tisotumab vedotin (targeting tissue factor) has shown no significant therapeutic response in mCRPC. Meanwhile, disitamab vedotin (HER2-targeted), ABBV-969 (dual PSMA/STEAP1-targeted), and DXC008 (dual PSMA/STEAP1-targeted) are currently under evaluation. Notably, the B7-H3-targeted ADC ifinatamab deruxtecan has initiated..."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2 • SLC44A4 • SLC4A4 • STEAP1

RC48-ADC Combined with Radiotherapy and Immunotherapy as Salvage Therapy for Advanced Solid Tumors with HER2 Expression: A Multicenter, Phase II Trial (ASTRO 2025) - No abstract available

Clinical • IO biomarker • Metastases • P2 data • Oncology • Solid Tumor • HER-2

Kidney-Sparing Approach for Selected Localized High-Risk Upper Tract Urothelial Carcinoma: A Pilot Study Combining Endoscopic Thulium Laser Ablation with Perioperative Disitamab Vedotin and Immune Checkpoint Inhibitors (ESMO 2025) - No abstract available

Checkpoint inhibition • Clinical • Oncology • Solid Tumor • Urothelial Cancer

Antibody-drug conjugates in breast cancer: current resistance mechanisms and future combination strategies. (PubMed, Cancer Drug Resist) - "From early agents (e.g., gemtuzumab ozogamicin) to second-generation trastuzumab emtansine (T-DM1) and third-generation trastuzumab deruxtecan (T-DXd)/disitamab vedotin (RC48), ADCs have demonstrated significant clinical benefits, including improved progression-free survival (PFS) and overall survival (OS) in breast cancer, with several approved for clinical use. However, de novo and acquired resistance remains a critical barrier to maximizing therapeutic efficacy. This review summarizes ADC mechanisms and clinical outcomes in breast cancer, explores resistance mechanisms, and dissects the biological rationale for combination strategies, aiming to identify novel payloads that enhance patient outcomes."

Journal • Review • Breast Cancer • Oncology • Solid Tumor

Disitamab Vedotin in Combination with Immune Checkpoint Inhibitors as Neoadjuvant Therapy for Cisplatin-Intolerant Patients with Muscle-Invasive Bladder Cancer: A Real-World Retrospective Analysis (UAA 2025) - "Introduction:Neoadjuvant cisplatin-based combination chemotherapy, typically combined with gemcitabine, is the standard first-line treatment for muscle-invasive bladder cancer (MIBC) and has been shown to improve overall survival (OS) by approximately 8% at five years...The treatment regimen consisted of Disitamab Vedotin (DV) at 2 mg/kg every two weeks via intravenous injection, combined with Pembrolizumab or Tislelizumab at 200 mg, or Toripalimab at 3.0 mg/kg every three weeks via intravenous injection...Neoadjuvant treatment with Disitamab Vedotin (DV) in combination with immune checkpoint inhibitors demonstrated promising efficacy and safety in cisplatin-intolerant patients with muscle-invasive bladder cancer (MIBC)."

Checkpoint inhibition • Combination therapy • IO biomarker • Real-world • Real-world evidence • Retrospective data • Bladder Cancer • Endocrine Disorders • Fatigue • Genito-urinary Cancer • Nephrology • Oncology • Renal Disease • Solid Tumor • Urothelial Cancer

A prospective, double-cohort, open-label, phase II clinical study of cadonilimab combined with nab-paclitaxel or disitamab vedotin in the treatment of recurrent or metastatic cervical cancer (ChiCTR) - P2 | N=74 | Recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor • HER-2

Changes in Circulating Tumor Cells (CTCs) and HER-2 Expression as Indicators of Efficacy and Recurrence Prediction in Neoadjuvant Disitamab Vedotin (DV) Plus Toripalimab Treatment for Muscle-Invasive Bladder Cancer (MIBC): Updated Data and Preliminary Outcomes for Recurrence (ESMO 2025) - No abstract available

Circulating tumor cells • Clinical • Tumor cell • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CTCs • HER-2

PUNCH03: Prospective study of intra iliac artery infusion chemotherapy based on Her2 expression or combination of vediximab with trastuzumab and local infusion therapy for high-risk NMIBC (ChiCTR) - P2 | N=76 | Recruiting | Sponsor: The First Affiliated Hospital, Sun Yat-sen University; The First Affiliated Hospital, Sun Yat-sen University | Phase classification: P1 ➔ P2

Phase classification • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

Efficacy of Disitamab Vedotin, AK104, and Bevacizumab in HER2-Positive Recurrent Ovarian Clear Cell Cancer: Phase 2 DAB-OCCC Trial (ESMO 2025) - No abstract available

Clinical • P2 data • Oncology • Ovarian Cancer • Ovarian Clear Cell Cancer • HER-2

SGNDV-001: disitamab vedotin with pembrolizumab in HER2-expressing locally advanced or metastatic urothelial carcinoma. (PubMed, Future Oncol) - P3 | "Enfortumab vedotin, an antibody-drug conjugate, combined with pembrolizumab, a programmed death 1 (PD-1) inhibitor, recently demonstrated improved efficacy versus chemotherapy in la/mUC. Dual primary endpoints are progression-free survival (per blinded independent central review) and overall survival. Potential synergistic effects of disitamab vedotin and pembrolizumab could establish this combination as a novel therapeutic option for HER2-expressing la/mUC."

Journal • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Cadonilimab in combination with disitamab vedotin or nab-paclitaxel in the treatment of recurrent or metastatic cervical cancer: A prospective, double-cohort, multi-center, open-label, phase II clinical study (AK001) (ESMO 2025) - No abstract available

Clinical • Combination therapy • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

Final results of a multi-center phase Ib/II study of RC48-ADC combined with tislelizumab as neoadjuvant treatment in patients with HER2 positive locally advanced muscle-invasive urothelial bladder cancer(Hope-03) (ESMO 2025) - No abstract available

Clinical • Metastases • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

Overcoming immunotherapy resistance in bladder cancer with a novel antibody-drug conjugate RC48. (PubMed, J Immunother Cancer) - "RC48-ADC enhances immunotherapy by regulating PD-L1 through the Hippo-TAZ pathway and reactivating CD8+T cells, offering a novel combination therapeutic strategy for bladder cancer."

IO biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD8 • CTLA4 • CXCL14 • CXCL9 • HER-2

Postoperative Adjuvant Treatment of HER2-Overexpressing Upper Urinary Tract Urothelial Carcinoma with Disitamab Vedotin and Toripalimab: A Real-World Retrospective Study (UAA 2025) - No abstract available

Real-world • Real-world evidence • Retrospective data • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Biomarker Detection for Predicting the Efficacy of Neoadjuvant RC48-ADC Combined with Immunotherapy in MIBC Patients Using Single-Cell Sequencing (UAA 2025) - "Detecting the expression of HER2 and HSPA1A in C3 subcluster based on single-cell sequencing is expected to serve as a biomarker to predict the efficacy of neoadjuvant RC48-ADC combined with ICIs in the treatment of MIBC. UMAP plot of subclusters of BLCA epithelial cells.Based on the differentially expressed genes among subclusters, GO and KEGG enrichment analyses were conducted. By integrating the specific functions of each subcluster, the four different subclusters The scatter plot showed the median values of HER2 and HSPA1A in C3 BLCA epithelial cells of each sample, and it could be seen that patients who achieved CR had the characteristics of HSPA1A-HER2+."

Biomarker • Clinical • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Solid Tumor • HER-2 • HSPA1A

Disitamab Vedotin Plus Tislelizumab and S-1 as First-Line Therapy for HER2-Low Expressing Advanced Gastric Cancer: A Prospective, Open-label, Multicenter, Phase II Clinical Study (ChiCTR) - P2 | N=48 | Not yet recruiting | Sponsor: Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study. (PubMed, Neoplasia) - P2 | "These findings establish the feasibility, efficacy, and potential biomarker utility of a novel bladder-preserving regimen, setting the stage for a paradigm shift in MIBC management."

IO biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor