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

Efficacy and safety of disitamab vedotin combined with pyrotinib as neoadjuvant therapy for HER2-positive breast cancer: a phase II trial (SABCS 2025) - "Abstract is embargoed at this time."

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

Predictive Biomarkers of Response and Survival Following Treatment with the HER2-Targeted Antibody-Drug Conjugate Disitamab Vedotin in HER2-Expressing Metastatic Breast Cancer: A Proteomics-Based Study [WITHDRAWN] (SABCS 2025) - No abstract available

Biomarker • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety of Disitamab Vedotin Combined with Gemcitabine as Neoadjuvant Therapy in Muscle-invasive Bladder Cancer: An Open-label, Multicenter, Single-arm, Phase 2 Trial. (PubMed, Eur Urol) - "There are barriers to the clinical use of cisplatin-based neoadjuvant regimens in muscle-invasive bladder cancer (MIBC), especially for patients with renal dysfunction, hearing loss, heart diseases, or other severe comorbidities. Treatment-related adverse events primarily included aspartate aminotransferase elevation (35%), alanine aminotransferase elevation (38%), a decrease in appetite (23%), alopecia (23%), and sensory neuropathy (23%). Validation of the long-term efficacy of this regimen is required."

Journal • P2 data • Alopecia • Bladder Cancer • Cardiovascular • Genito-urinary Cancer • Heart Failure • Immunology • Nephrology • Oncology • Otorhinolaryngology • Pain • Renal Disease • Solid Tumor • Urothelial Cancer • HER-2

Real-world evaluation of the efficacy and safety of disitamab vedotin (RC48) in urothelial carcinoma. (PubMed, BMC Urol) - "RC48 showed encouraging activity and manageable safety in a real-world UC cohort. Prospective multicenter studies with longer follow-up are needed to validate these findings, compare monotherapy versus combination strategies, and define the optimal role of RC48 across UC disease stages."

HEOR • Journal • Real-world evidence • Hematological Disorders • Oncology • Solid Tumor • Urothelial Cancer

Comparing the combination of Disitamab vedotin (RC48), Xindilimab, and SOX regimen for the perioperative treatment of locally advanced gastric cancer with HER-2 overexpression using SOX regimen: A prospective, multicenter, phase II clinical study. (ChiCTR) - P2 | N=144 | Not yet recruiting | Sponsor: Cancer Hospital Affiliated to Shandong First Medical University; Cancer Hospital Affiliated to Shandong First Medical University

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

Efficacy and safety of antibody-drug conjugate combination therapy in advanced urothelial carcinoma. (PubMed, Front Oncol) - "A total of 645 patients from 5 trials investigating anti-nectin-4 (enfortumab vedotin, EV), anti-TROP2 (sacituzumab govitecan, SG), and anti-HER2 (disitamab vedotin, DV) ADCs were identified. Hepatotoxicity was predominantly found in anti-HER2 regimens. While ADC-based combination regimens show promising responses, they also have high rates of AEs in patients with aUC."

Journal • Alopecia • Fatigue • Hematological Disorders • Immunology • Neutropenia • Oncology • Pain • Solid Tumor • Urothelial Cancer • NECTIN4

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) - "Conclusions RC48 plus BCG instillation showed promising effect and well tolerated in HER2 high expression HR-NMIBC pts. The combination therapies might reduce the risk of BCG failure in HER2 high expression populations and avoid subsequent cystectomy."

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

Efficacy and safety of neoadjuvant disitamab vedotin plus toripalimab, followed by response-adapted bladder sparing, in patients with muscle-invasive bladder cancer: A real-world study (ESMO Asia 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Efficacy and safety of neoadjuvant disitamab vedotin plus toripalimab in patients with muscle-invasive bladder cancer: A real-world study [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Disitamab vedotin plus tislelizumab as nephron-sparing therapy for high-risk upper tract urothelial carcinoma: The phase II DISTINCT-I trial (ESMO 2025) - P2 | "HER2 overexpression (3+/2+: 42.1%) may correlate with enhanced response, warranting biomarker validation. This paradigm challenges RNU dominance in selected patients."

IO biomarker • P2 data • Oncology • Solid Tumor • Urothelial Cancer

Efficacy and safety of disitamab vedotin (DV) combined with tislelizumab as adjuvant therapy after radical surgery for patients with HER2-expression upper tract urothelial carcinoma (UTUC): A single-arm, prospective, phase Ⅱ study (ESMO Asia 2025) - No abstract available

Clinical • Surgery • Oncology • Solid Tumor • Urothelial Cancer • HER-2

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) - P2 | "The common treatment-related adverse events were G1-2, included alopecia, numbness in hands and feet , poor appetite , pruritus and rash. Conclusions Tislelizumab combined with RC48 demonstrated the efficacy and safety in utDNA-defined cCR pts for precise bladder preservation treatment."

Clinical • P2 data • Bladder Cancer • Oncology • HER-2

Phase II study of disitamab vedotin in combination with anlotinib in patients with HER-2 expressing platinum-resistant ovarian cancer (ESMO 2025) - P1 | "Legal entity responsible for the study The authors. Funding Has not received any funding."

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

Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study (ESMO Asia 2025) - No abstract available

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

High revenue growth, narrowing losses, positive cash flow (FUTU) - "The company achieved operating revenue of RMB 1.72 billion in the first three quarters, a significant year-on-year increase of 42.27%, mainly driven by continued strong sales growth of its two core products: Telitacicept for injection and Disitamab vedotin for injection. Revenue in Q3 alone reached RMB 622 million, up 33.13% year-on-year, indicating an accelerated commercialization process."

Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Myasthenia Gravis • Rheumatoid Arthritis • Systemic Lupus Erythematosus • Urothelial Cancer

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 [WITHDRAWN] (ESMO 2025) - No abstract available

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

Efficacy and safety of disitamab vedotin combined with gemcitabine as neoadjuvant therapy for muscle-invasive bladder cancer: A multi-center, single-arm, phase II trial (ESMO Asia 2025) - No abstract available

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

Disitamab Vedotin plus Toripalimab in HER2-Expressing Advanced Urothelial Cancer. (PubMed, N Engl J Med) - P3 | "Disitamab vedotin-toripalimab led to a significantly greater improvement in outcomes than chemotherapy among patients with untreated HER2-expressing locally advanced or metastatic urothelial cancer. (Funded by RemeGen and others; RC48-C016 ClinicalTrials.gov number, NCT05302284; ChinaDrugTrials.org.cn number, CTR20220348.)."

Journal • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • 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) - "Peng Du. Funding Has not received any funding."

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

Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression (ESMO 2025) - P3 | "Based on the data, RC48-C016, an open-label, multicenter, randomized phase 3 trial, was conducted to evaluate 1L treatment of DV+T vs C (gemcitabine+ cisplatin/carboplatin) in pts with HER2-expressing la/mUC in China. The safety profile of DV+T was more favorable than C (grade ≥3 treatment-related adverse events: 55.1% with DV+T and 86.9% with C). Conclusions DV+T significantly improved outcomes over C in pts with untreated HER2-expressing la/mUC."

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

Efficacy and safety of two bladder-preserving treatment durations with disitamab vedotin plus toripalimab combination in Her2-expressing muscle-invasive bladder cancer: A Phase II, open-Label, randomized clinical trial (ESMO Asia 2025) - No abstract available

Clinical • P2 data • 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 II DAB-OCCC trial (ESMO 2025) - P2 | "(%) Taxene 15 (100%) PARPi 4 (27%) Bevacizumab 11 (73%) Immune Therapy 1 (7%) Conclusions The combination of DV, AK104, and bevacizumab demonstrated clinically meaningful antitumor activity and a manageable safety profile in HER2-positive, PRR OCCC. This phase 2 trial met its pre-specified efficacy threshold in the first stage."

Clinical • IO biomarker • P2 data • Oncology • Ovarian Cancer • Ovarian Clear Cell Cancer • HER-2 • PD-L1

Preliminary efficacy and safety results from Formula-10: a phase II study of Disitamab Vedotin in locally advanced or metastatic extramammary Paget's disease with HER2 high expression (ESMO Asia 2025) - No abstract available

Clinical • Metastases • P2 data • Oncology • 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) - P2 | "Table: 1165P Antitumor activity assessed by RECIST version 1.1 Cohort I (n=18) Cohort II (n=17) ORR 8(44.4%) 11(64.7%) 95%CI 21.5 - 69.2 38.3 - 85.8 DCR 16(88.9%) 14(82.4%) 95%CI 65.3 - 98.6 56.6 - 96.2 Best overall response CR 3(16.7%) 0 PR 5(27.8%) 11(64.7%) SD 8(44.4%) 3(17.6%) PD 2(11.1%) 3(17.6%) Conclusions Our preliminary results provide an encouraging solution for the second-line treatment of r/mCC based on HER2 expression. CD plus DV may emerge as a novel effective regimen for HER2 positive r/mCC in the future."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor • HER-2

Intravesical Disitamab vedotin (RC48) for HER2-expressing high-risk non-muscle-invasive bladder cancer: an open-label, single-arm, dose-escalation phase I trial (ESMO Asia 2025) - No abstract available

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