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

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

RC48G001: A phase 2 study of disitamab vedotin in HER2-expressing previously treated advanced UC. (ASCO-GU 2026) - P2 | "Clinical Trial Registry Number: NCT04879329. The full, final text of this abstract will be available on Feb 27 at 10:00 AM EST."

Late-breaking abstract • Metastases • P2 data • 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 (EAU 2026) - No abstract available

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

Efficacy and safety of DV in HER2-negative and HER2-low locally advanced or metastatic urothelial carcinoma: Results of a phase 2 study. (PubMed, Med) - P2 | "This is the first exploratory trial demonstrating substantial anti-tumor activity and a manageable safety profile using a HER2-targeting agent in patients with HER2-low mUC. This study was registered at ClinicalTrials.gov (ClinicalTrials.gov: NCT04073602)."

Journal • P2 data • Hematological Disorders • Leukopenia • Oncology • 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

Disitamab Vedotin and Adebrelimab in combination with SOX in the perioperative treatment of HER2-expressing Locally Advanced Esophageal Adenocarcinoma and Esophagogastric Junction Adenocarcinoma: A Prospective, Single-Arm Phase II Study (ChiCTR) - P2 | N=39 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

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

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

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

Re: Disitamab Vedotin plus Toripalimab in HER2-expressing Advanced Urothelial Cancer. (PubMed, Eur Urol) - No abstract available

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

Disitamab Vedotin combining with Toripalimab versus adjuvant Toripalimab in HER2 expressed high-risk MIBC patients after radical cystectomy: a prospective, multicentre, open-label, randomised, phase 3 trial (ChiCTR) - P3 | N=128 | Recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P3 trial • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Disitamab Vedotin combining with Toripalimab versus adjuvant Toripalimab in HER2 expressed locally advanced UTUC patients after nephron-ureterectory: a prospective, multicentre, open-label, randomised, phase 3 trial (ChiCTR) - P3 | N=106 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P3 trial • Oncology • Solid Tumor • Urothelial Cancer • 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

This study aims to evaluate the efficacy and safety of Disitamab Vedotin combined with Cisplatin and Candelinib in the treatment of patients with locally advanced cervical cancer. (ChiCTR) - P=N/A | N=30 | Recruiting | Sponsor: Dalian Medical University Second Affiliated Hospital; Dalian Medical University Second Affiliated Hospital

New trial • Cervical Cancer • Gastric Cancer • Oncology • Solid Tumor • PD-L1

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

Phase 2 clinical study evaluating the efficacy and safety of disitamab vedotin with or without pembrolizumab in patients with HER2-expressing urothelial carcinoma (RC48G001). (ASCO-GU 2023) - P2 | "Enrollment for all cohorts is ongoing in North America and Europe, and planned in Latin America, Asia-Pacific, and Israel. Clinical trial information: NCT04879329."

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

Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with HER2-expressing muscle-invasive bladder cancer (MIBC) in the phase II RC48-C017 trial: Updated results. (ASCO-GU 2026) - P2 | "Clinical Trial Registry Number: NCT05297552. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

Phase 3 study of disitamab vedotin with pembrolizumab vs chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma that expresses HER2 (DV-001). (ASCO 2024) - P3 | "Recently, enfortumab vedotin, a nectin-4-directed antibody-drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload, plus pembrolizumab (pembro) showed improved survival over chemo...Pts in Arm B will receive platinum-based chemo with gemcitabine IV on Days 1 and 8 of every 3-week cycle, and either cisplatin or carboplatin on Day 1 of every 3-week cycle for 4-6 cycles. Maintenance therapy with avelumab after completion of chemo may be given to eligible pts where approved and available...Primary endpoints include PFS per blinded independent central review and OS. Enrollment is ongoing in the US, Canada, and Australia and is planned globally."

Clinical • IO biomarker • Metastases • P3 data • Oncology • Solid Tumor • Urothelial Cancer • HER-2

A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov) - P3 | N=555 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

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 | " Pts with previously untreated HER2-positive (IHC 3+, or IHC 2+/FISH+) la/m G/GEJ cancer were randomized (1:1:1) to receive DV (2.5 mg/kg, Q2W) + Tor (3.0 mg/kg, Q2W) + CAPOX (oxaliplatin [OX]: 130 mg/m2, day 1; capecitabine [CAP]: 1000 mg/m2, days 1-14; Q3W) (experimental group [EG] 1), or DV + Tor +Tra (staring dose of 8 mg/kg followed by 6 mg/kg, Q3W) (EG2), or Tor + Tra + CAPOX (control group [CG] 1). In pts with HER2-positive la/m G/GEJ cancer, DV + Tor + Tra demonstrated a superior ORR, offering a potential chemo-free treatment option. In pts with HER2-low la/m G/GEJ cancer, DV + Tor + CAPOX showed superior ORR and PFS with a manageable safety profile; lowering the CAPOX dose improved tolerability of the combination therapy while maintaining high efficacy. *In pts with ≥1 post-baseline tumor assessment."

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

Exploratory Study of Disitamab Vedotin Combination Therapy in Advanced Gastrointestinal Tumors with HER2 Overexpression or Amplification (ChiCTR) - P2 | N=90 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Henan University of Chinese Medicine; The First Affiliated Hospital of Henan University of Chinese Medicine

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • HER-2

Neoadjuvant tislelizumab in combination with disitamab vedotin (RC48) followed by distal ureterectomy for patients with HER-2 expressing lower segment ureteral carcinoma (LSUC): A single-arm, phase II, single-center study. (ASCO-GU 2026) - P2 | "Clinical Trial Registry Number: NCT05837806. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Combination therapy • P2 data • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with muscle-invasive bladder cancer (MIBC) with HER2 expression: Updated efficacy and safety results from the phase II RC48-C017 trial. (ASCO-GU 2025) - P2 | "The updated data supported perioperative treatment with DV plus toripalimab had promising efficacy and acceptable safety in pts with HER2-expressing MIBC. It warrants further investigation in this patient population."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Disitamab vedotin plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (RC48-C014): a phase 1b/2 dose-escalation and dose-expansion study. (PubMed, Ann Oncol) - "The combination of DV and toripalimab demonstrated promising response rate and overall survival results with a manageable safety profile in HER2 unselected la/mUC patients. This combination represents a promising first-line option for la/mUC. Randomized phase III study is currently ongoing."

Journal • Metastases • P1/2 data • Oncology • Pain • Pneumonia • Solid Tumor • Urothelial Cancer