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

A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Pfizer

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Poised to Reshape Treatment Landscape: The Phase 3 Clinical Trial of Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic ‌Urothelial Carcinoma Reached its Primary Endpoints of PFS and OS (PRNewswire) - P3 | N=452 | NCT05302284 | Sponsor: RemeGen Co., Ltd. | "On May 12th, 2025, RemeGen Co., Ltd...announced that its phase 3 clinical trial (Study ID: RC48-C016) on disitamab vedotin (DV, brand name: Aidixi)...has reached its two primary endpoints of progression-free survival (PFS) and overall survival (OS)....The major subgroup analyses showed that DV combined with toripalimab significantly improved PFS and OS compared with the standard chemotherapy treatment, irrespective of cisplatin eligibility or HER2 expression level....Detailed data of this study are planned to be presented at major international academic conferences later this year. Subsequently, RemeGen plans to file Biologic License Application (BLA) for this indication to the Center of Drug Evaluation of National Medical Products Administration (NMPA) in China."

China filing • P3 data • Urothelial Cancer

Multimodal cancer therapy consisting of antibody-drug conjugates and radiotherapy in cancer treatment (AACR 2025) - "Accordingly, combination of RT with ADCs targeting HER2: trastuzumab emtansine/deruxtecan/duocarmazine (T-DM1/T-DXd/T-Duo) and disitamab vedotin, TROP2: datopotamab deruxtecan and sacituzumab govitecan, EGFR: depatuxizumab MMAE, HER3: patritumab deruxtecan, Nectin4: enfortumab vedotin and CEACAM5: tusamitamab ravtansine were evaluated. Together, this study demonstrates that inherent sensitivity of tumor cells to different payload classes, DAR and TAA dynamic are of relevance for the efficacy of ADC. Informed selection of ADC exhibited synergistic effects with RT providing a novel multimodal and promising strategy for efficient cancer eradication."

Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • CEACAM5 • EGFR • ERBB3 • HER-2 • NECTIN4

Overcoming resistance in HER2-positive gastric and breast cancers: Efficacy of disitamab vedotin in preclinical models resistant to trastuzumab emtansine and trastuzumab deruxtecan (AACR 2025) - "This study highlights the effectiveness of DV in overcoming resistance to T-DM1 and T-DXd in preclinical models of HER2-positive gastric and breast cancer. The combination of DV with these ADCs demonstrated enhanced efficacy, underscoring the potential of dual ADC strategies to improve outcomes in HER2-positive cancers."

Preclinical • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

NATIONAL MEDICAL PRODUCTS ADMINISTRATION GRANTED MARKETING APPROVAL FOR DISITAMAB VEDOTIN FOR INJECTION…FOR THE TREATMENT OF HER2-POSITIVE ADVANCED BREAST CANCER WITH LIVER METASTASIS IN CHINA (HKEXnews) - "The board of directors of the Company (the 'Board') is pleased to announce that disitamab vedotin for injection...has officially been approved for marketing in China by the National Medical Products Administration (the 'NMPA') for the treatment of HER2-positive advanced breast cancer patients with liver metastasis. The approval of this indication is based on the Phase III clinical study RC48-C006, with detailed data presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2024."

China approval • Evidence highlight • HER2 Positive Breast Cancer • HER-2

DIVON: Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

Phase II study of disitamab vedotin (RC48) in combination with tislelizumab and bevacizumab in patients (Pts) with HER2 alterations locally advanced or metastatic NSCLC: Primary analysis results of RESOLUTION. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06749860 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Safety and efficacy of neoadjuvant disitamab vedotin in combination with pertuzumab with or without toripalimab for HER2-positive breast cancer: An open-label phase II trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06178159 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Disitamab vedotin (DV) plus toripalimab (Tor) and chemotherapy (C)/trastuzumab (Tra) as first-line (1L) treatment of patients (pts) with HER2-expressing locally advanced or metastatic (la/m) gastric cancer. (ASCO 2025) - P2/3 | "Clinical Trial Registration Number: NCT05980481 The abstract will be released to the public on June 2, 2025 at 7:00 AM CDT"

Clinical • Late-breaking abstract • Metastases • Gastric Cancer • Oncology • Solid Tumor • HER-2

Postoperative Adjuvant Treatment of HER2-Overexpressing Upper Urinary Tract Urothelial Carcinoma with Disitamab Vedotin and Toripalimab: A Real-World Retrospective Study (AUA 2025) - "Disitamab vedotin combined with Toripalimab showed promising efficacy as adjuvant therapy following RNU for UTUC. Based on the one-year DFS outcomes, this combination may be considered as a potential adjuvant therapy option post-surgery."

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

Efficacy and safety of disitamab vedotin (RC48) combined with toripalimab as adjuvant therapy after radical surgery for patients with HER2-overexpression upper tract urothelial cancer (UTUC): A single-arm, prospective, phase 2 clinical trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05917158 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P2 data • Surgery • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

The Efficacy and Safety of Disitamab Vedotin combined with Immune Checkpoint Inhibitors in Patients with Metastatic Upper tract urothelial carcinoma: a Multicenter Real-World Study (AUA 2025) - "All eligible patients received RC48-ADC in combination with ICIs, primarily Toripalimab, Tislelizumab, and Pembrolizumab, administered as an intravenous infusion every 3 weeks until disease progression, unacceptable toxicity, death, or withdrawal of consent. The combination of RC48-ADC and ICI showed encouraging activity and acceptable toxicity in real-world mUTUC, especially in pre-selected populations. These findings warrant further investigation."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • Real-world • Real-world evidence • Alopecia • Fatigue • Immunology • Oncology • Pain • Solid Tumor • Urothelial Cancer • HER-2

A prospective multicenter clinical trial on the efficacy and safety of RC48-ADC (disitamab vedotin) combined with toripalimab in the treatment of HER2 positive locally advanced or metastatic scrotal Extramammary Paget's disease (ChiCTR) - P2 | N=20 | Not yet recruiting | Sponsor: Fujian Medical University Union Hospital; Fujian Medical University Union Hospital

New P2 trial • Rare Diseases • HER-2

A clinical exploratory study on the safety and efficacy of Disitamab Vedotin combined with cisplatin and Toripalimab in the neoadjuvant treatment of urothelial carcinoma (ChiCTR) - P=N/A | N=26 | Not yet recruiting | Sponsor: Beijing Anzhen Hospital, Capital Medical University; Beijing Anzhen Hospital, Capital Medical University

New trial • Oncology • Solid Tumor • Urothelial Cancer • HER-2 • PD-L1

Efficacy and safety of disitamab vedotin in combination with RC148 versus albumin-bound paclitaxel ± toripalimab for patients with HR-negative HER2-low-expressing unresectable locally advanced or metastatic breast cancer: An open-label, randomized, controlled phase II study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06642545 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

IMPROVE: Probiotics in Advanced Urothelial Carcinoma (clinicaltrials.gov) - P2 | N=222 | Recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Oncology • Solid Tumor • Urothelial Cancer

Neoadjuvant Therapy with Combined Targeted HER2 and Immunotherapy for T2-T4N0-1M0 Bladder Cancer: A Retrospective Multicenter Study (AUA 2025) - "The combination of RC48 (Disitamab Vedotin) and Toripalimab/Tislelizumab as a neoadjuvant therapy for patients with T2-T4N0-1M0 bladder cancer demonstrated promising results in terms of pathological response, progression-free survival, and overall survival. The therapy was well tolerated with manageable adverse reactions. These findings support further investigation into this combination as a neoadjuvant treatment option in bladder cancer, particularly for patients with locally advanced disease."

Retrospective data • Bladder Cancer • Fatigue • Gastrointestinal Disorder • Genito-urinary Cancer • Oncology • Solid Tumor

An exploratory clinical study investigating the neoadjuvant treatment of HER2-low expressing, stage II-III breast cancer with disitamab vedotin combined with penpulimab (RCVDBCIIR005). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05726175 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Updated results from a phase II study of perioperative disitamab vedotin (RC48-ADC) plus cadonilimab (AK104) for HER2-expressing muscle-invasive bladder cancer (MIBC). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06074484 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=616 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Neoadjuvant treatment with disitamab vedotin monotherapy in patients with HER2-overexpressing muscle invasive bladder cancer (MIBC): An open-label, single-arm, phase II study. (ASCO 2025) - P=N/A | "Clinical Trial Registration Number: ChiCTR2300068270 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Monotherapy • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

Disitamab vedotin (RC48), tislelizumab, and S-1 as first-line therapy for HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC): Updated results from the RCTS trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05586061 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

PUNCH03: A phase II study of disitamab vedotin combined with tislelizumab and bacillus Calmette-Guerin (BCG) in Her2-positive high-risk non-muscle-invasive bladder cancer (HR NMIBC). (ASCO 2025) - P1 | "Clinical Trial Registration Number: ChiCTR2400093839 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

Real-world effectiveness and safety of RC48-ADC combined with PD-1 inhibitors for patients with metastatic urothelial carcinoma: A retrospective multicenter study. (ASCO 2025) - "Clinical Trial Registration Number: 2024KY277 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Metastases • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Oncology • Solid Tumor • Urothelial Cancer

The potential of disitamab vedotin in bladder preservation during neoadjuvant therapy for bladder cancer: A comparative analysis with the GC regimen. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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