Aidixi (disitamab vedotin) / Pfizer, RemeGen - LARVOL DELTA

Case Report: Solitary right thigh skin metastasis of bladder cancer misdiagnosed as erysipelas with literature review. (PubMed, Front Oncol) - "Based on prior intolerance to cisplatin-based chemotherapy and the tumor biomarker profile, combination therapy with disitamab vedotin and tislelizumab was initiated. Molecular profiling may help identify actionable targets and guide systemic treatment. This case highlights the diagnostic challenge of erysipelas-like cutaneous metastasis and suggests the potential value of biomarker-guided HER2-directed antibody-drug conjugate plus Programmed cell death protein 1 (PD-1) inhibitor therapy in selected patients with metastatic urothelial carcinoma, while emphasizing the need for careful monitoring of immune-related toxicity."

IO biomarker • Journal • Bladder Cancer • Dermatology • Endocrine Disorders • Genito-urinary Cancer • Nephrology • Oncology • Pain • Renal Disease • Solid Tumor • Urothelial Cancer • GATA3 • PD-L1

Case Report: Radical nephroureterectomy after toripalimab plus disitamab vedotin in biomarker-non-enriched upper tract urothelial carcinoma. (PubMed, Front Oncol) - "The observed lesion reduction is hypothesis-generating and should not be interpreted as evidence of clinical efficacy. Standardized response assessment and longer follow-up are required."

Biomarker • IO biomarker • Journal • Oncology • Solid Tumor • Urothelial Cancer • CDX2 • CTNNB1 • HER-2 • PD-L1 • TACSTD2

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

Disitamab vedotin (RC48) and Cadonilimab (AK104) as first-line therapy for HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC): preliminary results of phase Ⅱ trial (ESMO 2026) - No abstract available

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

Complete and durable remission in a patient with brain metastasis from gastric cancer treated with SRS followed by RC48 plus camrelizumab after progression on chemo-immunotherapy: a case report and literature review. (PubMed, Front Immunol) - "HER2-low expression (IHC 1+ or IHC 2+/FISH-negative), historically excluded from anti-HER2 therapy, has now emerged as a novel therapeutic target for antibody-drug conjugates (ADCs) such as RC48 (disitamab vedotin). A 52-year-old male with HER2-low (IHC 2+/FISH-negative), PD-L1 CPS 5, microsatellite-stable (MSS) advanced gastric cancer received first-line XELOX plus camrelizumab, achieving a partial response (PR) followed by progression with new brain metastases...We review the current evidence for HER2-low gastric cancer treatment, ADC plus ICI combinations, the potential immunomodulatory role of radiotherapy (including the abscopal effect) as it may contribute to systemic antitumor responses when combined with ICIs, and treatment-free remission following ICI discontinuation. This is the first report of durable, treatment-free survival over 36 months in an ICI-refractory, HER2-low gastric cancer patient with brain metastasis suggests that RC48 can reverse PD-1..."

IO biomarker • Journal • Review • Gastric Cancer • Oncology • Pneumonia • Solid Tumor • PD-1 • PD-L1

Efficacy and safety analysis of disitamab vedotin combined with immunotherapy as neoadjuvant treatment to promote conversion to bladder preservation in bladder cancer: A retrospective comparative study with the GC combined with immunotherapy regimen. (PubMed, Urol Oncol) - "In this single-center retrospective cohort, DV plus toripalimab was associated with higher observed rates of strict cCR and strict cCR with initial bladder preservation than GC plus toripalimab among patients with T2-4 disease. These findings are hypothesis-generating and require validation in prospective multicenter studies with longer follow-up."

Journal • Retrospective data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Preliminary results of an open-label, single-arm, multi-center study on disitamab vedotin (DV) combined with torIpalimab and radiotherapy as bladder-preserving therapy in HER2 overexpression muscle-invasive bladder cancer (MIBC; DECIDING study-stage I). (ASCOBT 2024) - P2 | "DV combined with toripalimab instead of chemotherapy in TMT was well-tolerated in this early analysis. TRAE was consistent with prior trials and no DLTs in 28 days recived first drug therapy."

Clinical • Bladder Cancer • Dermatology • Diabetes • Dyslipidemia • Genito-urinary Cancer • Hypertriglyceridemia • Oncology • Pruritus • Solid Tumor • Urothelial Cancer • HER-2

Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: A global phase 1, multi-center, first-in-human study (AACR 2023) - "Background: SHR-A1811 is an ADC comprised of a humanized anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a DNA topoisomerase I inhibitor payload. SHR-A1811 was well-tolerated and showed promising antitumor activity in heavily pretreated advanced solid tumors.Table 1. Subgroup analyses of ORRNo. of prior treatment lines in metastatic setting in all pts (N=250)HER2 positive BC (N=108)HER2-low BC (N=77)Other tumor types (N=65)≤381.8% (45/55)58.7% (27/46)36.7% (18/49)>381.1% (43/53)51.6% (16/31)31.3% (5/16)Prior anti-HER2 therapies in pts with BC (N=185)*HER2 positive BC (N=108)HER2-low BC (N=77)All BC (N=185)Any82.2% (88/107, 73.7-89.0)68.8% (11/16, 41.3-89.0)80.5% (99/123, 72.4-87.1)Trastuzumab81.9% (86/105, 73.2-88.7)75.0% (9/12, 42.8-94.5)81.2% (95/117, 72.9-87.8)Pertuzumab83.0% (39/47, 69.2-92.4)100% (5/5, 47.8-100)84.6% (44/52, 71.9-93.1)Pyrotinib86.9% (53/61, 75.8-94.1)71.4% (5/7, 29.0-96.3)85.3% (58/68, 74.6-92.7)Lapatinib80.0% (28/35,..."

Clinical • Metastases • P1 data • PK/PD data • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Preliminary efficacy and safety of disitamab vedotin (DV) with pembrolizumab (P) in treatment (Tx)-naive HER2-expressing, locally advanced or metastatic urothelial carcinoma (la/mUC): RC48G001 cohort C (ESMO 2024) - P2, P3 | "DV+P demonstrated encouraging preliminary activity in pts with HER2-expressing la/mUC with a manageable safety profile and supports further evaluation of this regimen. RC48G001 Cohort C Part 2 (DV vs DV+P) and DV001 (DV+P vs platinum-based chemo; phase 3 study; NCT05911295) are ongoing."

Clinical • Metastases • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

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 of disitamab vedotin (RC48) plus tislelizumab and S-1 as first-line therapy for HER2-overexpressing advanced stomach or gastroesophageal junction adenocarcinoma: A multicenter, single-arm, phase II trial (RCTS). (ASCO 2024) - P2 | "Background: Integrating immunotherapy with trastuzumab and chemotherapy has shown a significant improvement in overall response rate (ORR) and progression-free survival (PFS) in HER2-overexpression gastric or gastroesophageal junction cancer (GC/GEJC). The combination of RC48, Tislelizumab, and S-1 showed notable efficacy with manageable safety in the first-line treatment of advanced HER2-overexpressing GC/GEJC patients. These findings support further exploration in this context."

Clinical • IO biomarker • Metastases • P2 data • Esophageal Cancer • Fatigue • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • HER-2 • PD-L1

Phase II clinical study evaluating the efficacy and safety of disitamab vedotin in patients (pts) with HER2-expressing urothelial carcinoma (RC48G001) (ESMO 2022) - P2 | "Nearly half of all pts cannot tolerate standard cisplatin-based first line (1L) chemotherapy and opportunity still exists to improve outcomes in both 1L and later lines of therapy...DV elicits antitumor activity through MMAE-directed cytotoxicity and bystander effect (Li 2020)...Secondary endpoints include ORR assessed by investigator, duration of response, progression-free survival, disease control rate, overall survival, safety, and pharmacokinetic parameters. Enrollment for cohorts A and B is ongoing in North America and EU, and planned in LATAM, APAC, and Israel."

Clinical • P2 data • Bladder Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Disitamab Vedotin-Associated Psoriasis. (PubMed, Am J Ther) - No abstract available

Journal • Dermatology • Immunology • Psoriasis

Clinical activity and safety of disitamab vedotin plus lenvatinib in previously treated HER2-expressing advanced biliary tract cancer: a prospective single-arm phase II study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • HER-2

Navigating Antibody-Drug Conjugate Sequencing in Gastric Cancer: Cross-Resistance Biology, Target Switching, and Decision-Making Frameworks for the Post-Progression Landscape. (PubMed, Curr Oncol Rep) - "Antibody-drug conjugates (ADCs) have reshaped the therapeutic landscape of advanced gastric cancer, with trastuzumab deruxtecan (T-DXd) and disitamab vedotin (RC48) establishing new standards for HER2-positive disease, and a wave of Claudin 18.2 (CLDN18.2)-directed ADCs demonstrating promising early efficacy. We propose a three-pillar decision-making framework integrating cross-resistance risk stratification, target landscape reassessment, and patient-clinician shared decision-making, accompanied by four practical sequencing scenarios. This framework is intended as a conceptual scaffold to guide clinical reasoning while awaiting the prospective trials urgently needed to establish evidence-based sequencing strategies in gastric adenocarcinoma."

Journal • Review • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Phase 3 study of disitamab vedotin with pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma that expresses HER2 (DV-001; trial in progress) (EAU 2024) - No abstract available

Clinical • Metastases • P3 data • Oncology • Solid Tumor • Urothelial Cancer • 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) - 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

Neoadjuvant Tislelizumab plus Disitamab Vedotin for UTUC: Mid-term Results of the Phase II WUTSUP-02 Trial (ESMO 2026) - No abstract available

Clinical • P2 data • Oncology

QL1706 plus disitamab vedotin in platinum-refractory or platinum-intolerant unresectable locally advanced or metastatic penile squamous cell carcinoma: BRIGHT-01, a prospective phase II study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Oncology • Penile Cancer • Squamous Cell Carcinoma

Disitamab vedotin, a HER2-directed antibody-drug conjugate, in patients with HER2-overexpression and HER2-low advanced breast cancer: a phase I/Ib study. (PubMed, Cancer Commun (Lond)) - "DV demonstrated promising efficacy in HER2-overexpression and HER2-low ABC, with a favorable safety profile at 2.0 mg/kg Q2W."

Journal • Metastases • P1 data • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Pain • Peripheral Neuropathic Pain • Solid Tumor

Preliminary efficacy and safety results from RC48-C017: A phase II study of neoadjuvant treatment with disitamab vedotin plus toripalimab in patients with muscle invasive bladder cancer (MIBC) with HER2 expression. (ASCO 2024) - P2 | "Neoadjuvant treatment with DV plus toripalimab showed promising efficacy results and was well tolerated in operable MIBC pts with HER2 expression. These results will support further investigation for DV plus toripalimab in this population."

Clinical • IO biomarker • P2 data • Alopecia • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Pain • Solid Tumor • Urothelial Cancer • HER-2

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

Perioperative Disitamab Vedotin plus Sintilimab and XELOX for Resectable HER2-overexpression Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Study (ESMO 2026) - No abstract available

P2 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Induction chemotherapy followed by toripalimab, disitamab vedotin, and radiotherapy for bladder preservation in HER2-positive muscle-invasive bladder cancer (MIBC): An open-label, single-arm study (ESMO 2026) - No abstract available

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

RC48G001: A phase 2 study of disitamab vedotin in HER2-expressing previously treated advanced UC. (ASCO-GU 2026) - P2 | "This is the first presentation of DV monotherapy outcomes in a global population with HER2-expressing la/mUC. DV demonstrated promising antitumor activity and a manageable safety profile, consistent with results from China, supporting further evaluation. aBy BICR."

Late-breaking abstract • Metastases • P2 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2