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

Antibody-Drug Conjugates in Urothelial, Prostate, and Renal Cell Cancers: A Review of Current and Emerging Therapies. (PubMed, Crit Rev Oncol Hematol) - "Recent trials demonstrate encouraging outcomes with ADC such as Enfortumab Vedotin (EV), Sacituzumab Govitecan (SG), Trastuzumab Deruxtecan (T-DXd), and Disitamab Vedotin (DV) in UC, improving response rates and Progression-Free Survival (PFS). In RCC, ADC against ENPP3, CD70, and TIM-1 show durable responses in early trials, though challenges such as dose-limiting toxicities require further investigation. Overall, this review underscores ADC as a transformative approach in uro-oncology, highlighting ongoing advancements in combination strategies and biomarker-driven applications to refine therapeutic outcomes and expand treatment options for these challenging malignancies."

IO biomarker • Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Urethral Cancer • Urothelial Cancer • CD276 • CD70 • KIM1 • NECTIN4

A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: Tongji Hospital

New P2 trial • Bladder Cancer • Genito-urinary Cancer • 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) - P=N/A | "The DV/tislelizumab combination demonstrated promising preliminary efficacy and a manageable safety profile as adjuvant therapy in patients with HER2-expression UTUC."

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

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) - P4 | "Background: Neoadjuvant cisplatin-based therapy for muscle-invasive bladder cancer (MIBC) is limited by renal toxicity and low pathological complete response (pCR) rates.Muscle-invasive bladder cancers (MIBCs) is a group of molecularly heterogonous diseases that could be stratified into subtypes with distinct clinical courses and sensitivities to chemotherapy. Neoadjuvant GD demonstrates promising efficacy (63.6% pCR) and tolerability in HER2-positive MIBC. Four-cycle regimens may enhance responses in advanced-stage disease (>T2)."

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

Preliminary efficacy and safety results from Formula-10: A phase II study of dsitamab vedotin in locally advanced or metastatic extramammary Paget's disease with HER2 high expression (ESMO Asia 2025) - P2 | "Disitamab Vedotin (DV) is a novel anti-HER2 antibody-drug conjugate... DV demonstrated a promising and encouraging efficacy with relatively low toxicity in HER2 high expression la/m EMPD including chemotherapy resistance pts. The long-term efficacy also needs further exploration."

Clinical • Metastases • P2 data • Oncology • HER-2

RC48 combined with anlotinib for HER2-variated advanced non-small cell lung cancer: A prospective, single-arm study (ESMO Asia 2025) - P1/2 | "The preliminary results indicate that RC48 plus Anlotinib provides potential treatment option for the previously treated NSCLC patients with HER-2 variation."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • 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) - "The primary end point is one year BI-DFS. The secondary end points included overall survival (OS), recurrence-free survival (RFS), clinical complete responsec (cCR) and safety."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • 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) - "DV-toripalimab combination demonstrates promising neoadjuvant efficacy and manageable toxicity in HER2-expressing MIBC, enabling bladder-sparing in selected candidates."

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

Efficacy and safety of disitamab vedotin (RC48) in combination with sintilimab and XELOX for perioperative therapy of G/GEJ cancer with HER2 overexpression: Preliminary results of a prospective, single-arm, phase II study. (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT06227325 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Combination therapy • P2 data • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2

Disitamab vedotin (RC48-ADC) combined with immunotherapy as neoadjuvant therapy for localized muscle-invasive bladder cancer: a multicenter real-world study. (PubMed, NPJ Precis Oncol) - "Neoadjuvant cisplatin-based combination chemotherapy or perioperative durvalumab with neoadjuvant gemcitabine-cisplatin has been the primary treatment for localized muscle-invasive bladder cancer (MIBC)...Twenty-five patients (cT2-4aN0-2M0) received at least four cycles of RC48 (2.0 mg/kg, Q2W or Q3W) with toripalimab, tislelizumab, or pembrolizumab, followed by radical cystectomy...Treatment-related adverse events were manageable. These findings suggest that RC48 combined with PD-1 inhibitors is a promising neoadjuvant strategy for localized MIBC and warrants further validation in biomarker-selected populations."

IO biomarker • Journal • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

Disitamab Vedotin plus Toripalimab - New Players in Urothelial Carcinoma. (PubMed, N Engl J Med) - No abstract available

Journal • Oncology • Solid Tumor • Urothelial Cancer

Unconjugated MMAE Pharmacokinetics in Combination with Tucatinib in Patients with HER2 Expressing Locally Advanced or Metastatic Breast and Gastric Cancer (SABCS 2025) - P2 | "Background: Disitamab vedotin (DV) is a human epidermal growth factor receptor 2 (HER2) targeting antibody drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload via a maleimidocaproyl-valine-citrulline (MC-VC) linker...A clinical drug-drug interaction (DDI) study previously showed that ketoconazole, a strong CYP3A4 and P-gp inhibitor, increased unconjugated MMAE exposure 1.34-fold following brentuximab vedotin (BV) treatment in patients with CD30+ hematologic malignancies1... Unconjugated MMAE exposure following DV administration of 1.25 mg/kg or 1.5 mg/kg Q2W was increased <1.3-fold in the presence of tucatinib in participants with HER2 expressing LA/mBC or LA/mGC/GEJC, translating to an overall weak DDI impact."

Clinical • Combination therapy • Metastases • PK/PD data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • TNFRSF8

An Exploratory Clinical Study for Neoadjuvant Treatment of HER2-low Expressing, Stage II-III Breast Cancer with Vedolizumab in Combination with Pembrolizumab (SABCS 2025) - "Background: HER2-low expressing breast cancer is a heterogenous subtype with limited targeted therapeutic options. Although the clinical benefit may be limited, the combination of Disitamab Vedotin and Penpulimab as neoadjuvant treatment for HER2-low expressing, stage II-III breast cancer shows manageable safety and potential for further refinement, warranting additional investigation to optimize treatment strategies. Pretreatment CD4+ TIL density and total immune infiltration may serve as predictive markers for neoadjuvant response."

Clinical • Combination therapy • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD4 • CD8 • HER-2 • PD-L1

Efficacy and safety of disitamab vedotin combined with pyrotinib as neoadjuvant therapy for HER2-positive breast cancer: a phase II trial (SABCS 2025) - "Post-surgery, adjuvant therapy (epirubicin 90 mg/m² + cyclophosphamide 600 mg/m² Q3W, cycles 5-8) was administered, followed by maintenance therapy (cycles 9-22): trastuzumab + pertuzumab for pCR patients, T-DM1 or trastuzumab + pertuzumab for non-pCR patients. This first neoadjuvant study combining HER2-ADC and TKI demonstrated a chemo-free neoadjuvant regimen with high efficacy. The safety profile was manageable, with hepatic toxicity requiring longer follow-up. These results support randomized evaluation against standard chemotherapy-containing regimens."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • 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 [WITHDRAWN] (ESMO Asia 2025) - No abstract available

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

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

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

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

Efficacy and safety of a novel treatment scheme of RC48-ADC plus PD-1 inhibitors in metastatic urothelial carcinoma: a multicenter real-world study. (PubMed, Ther Adv Med Oncol) - "Grade III TRAEs occurred in seven patients (11.1%), and no Grade IV or V TRAEs were observed. The combination of RC48 and PD-1 inhibitors administered in 3-week cycles demonstrates efficacy and manageable safety as first-line therapy for mUC patients in a real-world setting."

Journal • Real-world evidence • Dermatology • Fatigue • Hematological Disorders • Oncology • Pain • Pruritus • Solid Tumor • Urothelial Cancer

Primary high-grade urothelial carcinoma of the prostate combined with acinar adenocarcinoma: first rare case report and treatment experience summary. (PubMed, Front Oncol) - "Postoperatively, a surgery combined with targeted and immunotherapy regimen was initiated: leuprorelin + rezvilutamide for the acinar adenocarcinoma and disitamab vedotin + toripalimab for the urothelial carcinoma. The protocol of surgery combined with targeted and immunotherapy offers a new treatment strategy for this rare malignancy. This study provides valuable insights for clinical diagnosis and management."

Journal • Benign Prostatic Hyperplasia • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • Urothelial Cancer • GATA3

Future directions for antibody-drug conjugates in urothelial cancer. (PubMed, Expert Rev Anticancer Ther) - "ADCs are rising as a cornerstone in UC, but important challenges remain. Future perspectives point toward the development of combination strategies and next-generation ADCs, designed to overcome resistance, minimize toxicity, and enhance selectivity."

Journal • Review • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Complete response of advanced HER2-amplified lung adenocarcinoma to cadonilimab combined with disitamab vedotin: a case report. (PubMed, Front Oncol) - "Thus, this combination therapy may offer a promising, effective, and well-tolerated treatment alternative for similar patients. Further clinical trials are warranted to validate these findings and potentially establish a new standard of care for this subset of lung cancer patients."

IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • PD-1 • PD-L1

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