RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

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Sequence Code 616718896H

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Sequence Code 616718897L

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157

Clinical Trials associated with Disitamab Vedotin

NCT07142200

/ Not yet recruitingPhase 2IIT

A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy as Bladder-preserving Therapy in Patients With Localized HER2-high Expressing Muscle-invasive Bladder Urothelial Carcinoma Following Maximal Transurethral Resection

This is a prospective, open label, multicenter clinical study of vediximab combined with PD-1 and radiation therapy for bladder preservation in MIBC patients with HER-2 high expression (IHC 2+or 3+), conducted in accordance with Good Clinical Practice (GCP).
Each patient received treatment with Vediximab injection [2.0 mg/kg, Q2W, iv] and Triprolizumab injection [3mg/kg, Q2W, iv] for one cycle, followed by concurrent radiotherapy in the second cycle. Assuming a 20% improvement in the efficacy of conventional TMT bladder protection treatment, i.e. an increase in CR rate from 60% to 80%, alpha of 0.05, and beta of 0.2, a sample size of 36 is required. Considering a 20% dropout rate, 45 subjects need to be enrolled.
The subjects need to undergo maximum transurethral resection of the bladder (TURBT) and imaging diagnosis, and collect urine samples before treatment. The researchers judged that localized myometrial invasive bladder cancer with high HER2 expression could be treated with bladder conserving therapy by maximizing TURBT. The patient will receive treatment with vediximab combined with PD-1 and radiotherapy after TURBT surgery (without the need for secondary resection).
The subjects should receive treatment with vediximab combined with PD-1 every two weeks for a total of 12 treatment cycles, and receive radiation therapy simultaneously. The specific number of treatment cycles will be determined by the researchers based on the patient's response to the treatment, tolerance to the regimen, and overall judgment of the condition. Patients with safety intolerance caused by any drug treatment will be reduced or discontinued according to the dosage adjustment plan specified in the regimen.
After completing the above treatments, the pathology, imaging, and cytology of the tumor site were obtained through diagnostic TURBT or cystoscopy for tumor evaluation to assess whether complete remission was achieved. The first tumor efficacy evaluation was conducted 3 months after receiving treatment, and the researcher judged whether to continue treatment based on the patient's treatment status. After completing the treatment for the next 3 months, another tumor efficacy evaluation was conducted. After completing all 12 treatment cycles (6 months), the patient underwent two tumor evaluations at the 6th month (from the 12th month of treatment) and the 12th month (from the 24th month of treatment), respectively.

Start Date01 Sep 2025

Sponsor / Collaborator

Shanghai Renji Hospital

NCT07100184

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for Patients With HER2-Expressing High-Risk or Very High-Risk Non-Muscle Invasive Bladder Cancer

This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT). The study plans to enroll 30 patients with high or very high risk HER2-expression NMIBC without visible lesions after TURBT. The study includes a screening period, a treatment period, and a survival follow-up period. This is a single-center study conducted at the Peking University First Hospital, and the PI is Prof. CuiJian Zhang.

Start Date01 Sep 2025

Sponsor / Collaborator

Peking University First Hospital

[+1]

NCT07151560

/ Not yet recruitingPhase 2IIT

Disitamab Vedotin Plus Toripalimab for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial

This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety.

Start Date30 Aug 2025

Sponsor / Collaborator

Wuhan University People's Hospital

100 Clinical Results associated with Disitamab Vedotin

100 Translational Medicine associated with Disitamab Vedotin

100 Patents (Medical) associated with Disitamab Vedotin

660

Literatures (Medical) associated with Disitamab Vedotin

31 Dec 2025·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

Author: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Hainzl, Dominik ; Barzaghi-Rinaudo, Patrizia ; Sagar, Vivek ; Korn, Joshua ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

01 Dec 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

RC48-targeted two-dimensional black phosphorus nanoplatform for precise photothermal-immunotherapy of HER2-positive breast cancer

Article

Author: Ni, Wenxiu ; Lin, Haoyu ; Chen, Guanyuan ; Yang, Ruiqian ; Xiao, Feiyang ; Lu, Hongwei ; Zhou, Benqing ; Lin, Ziyang ; Li, Xinrui ; Liang, Yuanke ; Chen, Shuzhao ; Fang, Xinqiang

Despite advances in targeted therapy for HER2-positive breast cancer, tumor-intrinsic resistance mechanisms including defective antigen presentation and adaptive immune suppression remain a significant challenge, constraining therapeutic efficacy. In this study, we developed a multifunctional nanotherapeutic system based on tumor-selective antibody-drug conjugate (ADC) disitamab vedotin (RC48) that co-delivered PEGylated black phosphorus (BP) and resiquimod (R848, a TLR7/8 agonist), thereby enhancing photothermal tumor ablation while activating antitumor immunity in HER2-positive breast cancer. The formed BP-PEG-RC48-R848 nanocomposites exhibited favorable photothermal stability and effectively induced the maturation of dendritic cells while promoting the secretion of pro-inflammatory M1 cytokines. In vivo fluorescence imaging demonstrated specific accumulation of the nanocomposites within HER2-positive tumors. Under near-infrared laser irradiation, the HER2-targeting nanocomposites effectively ablated primary local tumors and elicited concomitant immune activation, collectively inhibiting tumor progression in vivo. By integrating ADC drugs with photothermal-immunotherapy, the nanocomposites demonstrated enhanced precision and synergistic antitumor efficacy of HER2-positive breast cancer.

01 Oct 2025·NEOPLASIA

Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study

Article

Author: Zhang, Ruiyun ; Xie, Feng ; Xia, Jun ; Zhuang, Guanglei ; Chen, Haige ; Zhang, Tianxiang ; Cao, Dengfeng ; Zhang, Lu ; Tang, Haoran ; Qian, Lei ; Zang, Jingyu ; Ding, Yu ; Wu, Yuchen ; Jin, Di

PURPOSE:

Although trimodal therapy is currently the standard organ-sparing approach for muscle-invasive bladder cancer (MIBC), its clinical benefit is limited, and noninvasive biomarkers to guide dynamic decision-making are lacking. Here, we present a proof-of-concept study evaluating disitamab vedotin (RC48, a HER2-targeted antibody-drug conjugate) combined with toripalimab (JS001, anti-PD-1) and radiotherapy for bladder preservation in localized HER2-positive MIBC.

PATIENTS AND METHODS:

In the first-stage of an open-label phase II clinical trial (ClinicalTrials.gov identifier: NCT05979740), six patients were enrolled and received disitamab vedotin, toripalimab, and radiotherapy. Adverse events were documented according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0). Tumor response was evaluated every 12 weeks by radiographic imaging, cystoscopy with biopsies, and urine cytology. In parallel, we performed longitudinal liquid biopsy analyses of circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA) using PredicineCARE assay.

RESULTS:

The combination was overall tolerable, with no grade 4 treatment-related adverse events or deaths. Five patients (83.3 %) achieved a complete response and remained recurrence-free. Notably, utDNA testing showed high accuracy in monitoring therapeutic effectiveness and enabled early detection of tumor relapse, whereas ctDNA was largely undetectable across blood samples.

CONCLUSIONS:

These findings establish the feasibility, efficacy, and potential biomarker utility of a novel bladder-preserving regimen, setting the stage for a paradigm shift in MIBC management.

News (Medical) associated with Disitamab Vedotin

19 Aug 2025

·www.prnewswire.com

RemeGen and Santen Enter into Exclusive Licensing Agreement for Ophthalmic Innovative Drug RC28-E in Greater China and Asian countries

YANTAI, China, Aug. 18, 2025 /PRNewswire/ -- RemeGen Co., Ltd. (Stock Code: 688331.SH/09995.HK, "RemeGen"), a leading Chinese biopharmaceutical company, announced today that it has entered into an agreement with Santen Pharmaceutical (China) Co., Ltd. ("Santen China"), a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd. ("Santen"). Under the agreement, Santen China has obtained exclusive rights to develop, manufacture, and commercialize RC28-E in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) as well as in South Korea, Thailand, Vietnam, Singapore, the Philippines, Indonesia, and Malaysia. RemeGen will retain global exclusive rights to RC28-E outside these regions. RemeGen will receive upfront payment of RMB 250 million, development and regulatory milestone payments of up to RMB 520 million, and sales milestone payments of up to RMB 525 million. In addition, RemeGen will be entitled to tiered royalties based on net sales of the product in the licensed territories. RC28-E is a VEGF/FGF dual-target fusion protein drug for ocular neovascular diseases, independently developed by RemeGen. On May 7, 2025, the Phase II clinical trial results of RC28-E for diabetic macular edema (DME) were presented as an oral report at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting. The study demonstrated that RC28-E significantly improved best-corrected visual acuity (BCVA) and reduced central subfield thickness (CST), and was also well tolerated in patients with DME. In 2023, RemeGen initiated Phase III clinical trials for RC28-E in wet age-related macular degeneration (wAMD) and DME. RemeGen plans to submit a Biologics License Application (BLA) for the DME indication in China in the second half of 2025, followed by a BLA for wAMD in mid 2026. Dr. Jianmin Fang, CEO of RemeGen, stated: "Santen brings over 130 years of expertise in ophthalmology and a robust global sales network spanning 60+ countries and regions. RC28-E, a Class 1 proprietary drug developed by RemeGen, is approaching the critical stage of BLA submission. We believe this collaboration will fully leverage the strengths of both parties to maximize the potential of RC28-E, providing innovative and effective solutions for retinal diseases. This partnership not only lays a solid foundation for the future commercialization of RC28-E but also reflects international recognition of RemeGen's capabilities in ophthalmic drug development. We look forward to jointly advancing this breakthrough therapy with Santen to open a new chapter in eye care." Takeshi Ito, President & CEO of Santen, commented: "RemeGen has demonstrated outstanding capabilities and innovation in the field of novel drug development. As RemeGen's flagship pipeline in ophthalmology, RC28-E offers differentiated advantages by simultaneously targeting angiogenesis and fibrosis, potentially providing a new therapeutic approach and innovative option for the treatment of fundus diseases. Looking ahead, Santen are committed to strengthening cooperation and collaboration with all partners, by global-to-local synergy, to help advancing the high-quality development in ophthalmology, uncovering and addressing unmet patient needs, and aiming to realize 'Happiness with Vision 'for all." About RemeGen: RemeGen Co., Ltd. is a leading innovative biopharmaceutical company in China，headquartered in Yantai Economic & Technological Development Zone, China, with R&D centers and subsidiaries in Beijing, Shanghai, and California, USA. The company achieved dual listings on Main Board of The Stock Exchange of Hong Kong Limited (2020) and Shanghai Stock Exchange STAR Market (2022), becoming a dual-listed "A+H" company. The company focuses on discovering, developing, manufacturing, and commercializing novel biologic drugs with independent intellectual property rights. Focusing on critical therapeutic areas including autoimmune diseases, oncology, and ophthalmology, the company has successfully developed multiple biologic drugs with significant clinical value. In 2021, RemeGen's first-in-class drugs – Telitacicept (for systemic lupus erythematosus, rheumatoid arthritis, and myasthenia gravis) and Disitamab Vedotin (for gastric cancer, urothelial carcinoma, and breast cancer) – were approved for marketing with a total of 6 approved indications across these two innovative therapies. The company has established a comprehensive commercialization system encompassing production and sales, successfully initiating commercial transformation in both domestic and international markets. For more information, please visit RemeGen's website About Santen Pharmaceutical Co., Ltd.: As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of "Happiness with Vision" by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, "Tenki ni sanyo suru," Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen's mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience "Happiness with Vision." For more information, please visit Santen's website SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inPhase 1Phase 2Drug ApprovalClinical Result

11 Aug 2025

·www.globenewswire.com

Junshi Biosciences Announces the Acceptance of the sNDA for Toripalimab as the 1st-line Treatment of HER2-expressing Urothelial Carcinoma

Aug. 08, 2025 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application (“sNDA”) for toripalimab (trade name: TUOYI®) in combination with disitamab vedotin, an antibody-drug conjugate (“ADC”) developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is defined as a HER2 immunohistochemistry test result of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma (“UC”), has been accepted by the National Medical Products Administration (“NMPA”). This is toripalimab’s 13th application for marketing submitted in the Chinese mainland. UC is one of the ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising annually. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths reached over 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs. In 2021, toripalimab was approved for the second-line and above treatment of advanced UC, becoming the first immunotherapy drug approved for non-selective, population-based indications of advanced UC in China. Over the past 5 years, the emergence of PD-(L)1 monoclonal antibodies and novel ADCs has been continuously reshaping the treatment landscape for advanced UC. Compared with conventional chemotherapy, novel therapies have demonstrated significant improvements in terms of survival benefit and tolerability, leading to more diverse and precise treatment options for patients. The sNDA is based on results from the RC48-C016 study (NCT05302284), a multi-center, randomized, open-label and controlled phase 3 clinical trial, which evaluated the efficacy and safety of toripalimab in combination with disitamab vedotin versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2 (human epidermal growth factor receptor 2)-expressing locally advanced or metastatic UC. The study was conducted in 74 clinical centers across China with Professor Jun GUO from Beijing Cancer Hospital and Professor Aiping ZHOU from the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigators. In May 2025, the primary endpoints of progression-free survival (“PFS”, based on independent radiographic review) and overall survival (“OS”) of the RC48-C016 study met the pre-defined efficacy boundary. The results showed that in HER2-expressing, locally advanced or metastatic UC, toripalimab in combination with disitamab vedotin as a first-line treatment significantly improved PFS and OS compared to gemcitabine in combination with cisplatin/carboplatin. Toripalimab has a good safety profile that is consistent with previous studies, with no new safety signals identified. Further details will be presented at major international academic conferences. Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are twelve approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy; recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy; locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC; in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC); in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC); in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC; in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC); in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC); in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC); in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients; first-line treatment for unresectable or metastatic melanoma. The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore, United Arab Emirates, Kuwait and other countries and regions. In addition, toripalimab BLAs are under review in many countries or regions around the globe. Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalImmunotherapyClinical ResultCSCO

03 Jun 2025

·www.prnewswire.com

2025 ASCO ｜Oral Presentation: Disitamab Vedotin Achieves Stellar Efficacy as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Gastric Cancer

YANTAI, China, June 2, 2025 /PRNewswire/ -- On June 2 (Chicago time), in an oral presentation at the 2025 ASCO Annual Meeting, Dr. Lin Shen from Beijing Cancer Hospital presented the results of a Phase 2 clinical study conducted in China evaluating the efficacy and safety of disitamab vedotin (DV), developed by Remegen Co., Ltd., and toripalimab (PD-1) combined with CAPOX or trastuzumab as the first-line therapy for HER2-expressing patients with locally advanced or metastatic (la/m) gastric cancer. Comparing to the control group who received standard-of-care therapy, the DV combination therapy demonstrated clinically meaningful efficacy improvement, potentially to benefit patients who are non-responders to traditional targeted therapies. The data presented are from the Phase 2 part of a randomized, multi-cohort, seamlessly connecting Phase 2/3 study, which enrolled systematic chemotherapy-native patients with different HER2 expression levels. As of April 7, 2025, the results showed: Among HER2-overexpressing gastric cancer patients, compared to the PD-1-trastuzumab-CAPOX combination therapy, DV and PD-1 + chemotherapy as well as DV and PD-1 + trastuzumab both demonstrated statistically significant efficacy and favorable safety profiles. Objective response rate (ORR): 66.7% vs 82.4% vs 68.8%; Median progression-free survival (mPFS): NR vs NR vs 14.1 months, with risk of disease progression decreasing by 54%（HR=0.46）and 41% (HR: 0.59); 12-month PFS rate: 66.3%, 67% and 53.6%； Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. In patients with HER2-low-expressing gastric cancer, promising efficacy was observed with DV + PD-1 + CAPOX comparing to PD-1 + CAPOX, with a manageable safety profile. ORR: 72.0% vs 47.8%; mPFS: 9.9 vs 7.2 months, with risk of disease progression decreasing by 31% (HR: 0.69); Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. Dose optimization conducted in patients with HER2-median/low-expressing gastric cancer. Compared to PD-1 + CAPOX, DV at 2.5 mg/kg or 2.0 mg/kg combined with PD-1 + reduced-dose CAPOX showed significant efficacy, and better safety over the full-dose chemotherapy. ORR: 71.4% vs 66.7% vs 56.3%; 6-month PFS rate: 71.4%，72.7% and 53.3%. Globally, this is the first study to explore the triple combination therapy of "HER2 ADC + PD-1 + targeted medication" as first-line treatment of patients with la/m gastric cancer, pioneering a new mode of synergistic therapy. The multi-cohort design of this study provides precision treatment regimen for gastric cancer patients with different level of HER2 expression. For the HER2-overexpressing gastric cancer patients, DV + PD-1 + trastuzumab has the potential to become the new standard first-line treatment; for the HER2-low-expressing gastric cancer patients, DV + PD-1 + chemotherapy has the potential to fill the treatment gap of these patients. Based on the data obtained from the phase 2 study, the phase 3 clinical study of the triple combination therapy in patients with HER2-median/low-expressing gastric cancer has been initiated in April, 2025, in which 616 participants were planned to be enrolled, to further validate the efficacy of the DV combination therapy. Gastric cancer is the fifth most common malignant tumor in the world, and China accounts for about 42.6% of new cases and 45.0% of deaths worldwide. HER2 is an important target in the treatment of gastric cancer, while the traditional targeted drug trastuzumab is only effective in the population with high expression (IHC 3+ or IHC 2+/FISH+), and can easily become resistant. There is a lack of effective targeted therapy options for patients with low/median HER2 expression (IHC 1+ or IHC 2+/FISH-), and the efficacy of chemotherapy combined with immunotherapy is not satisfactory. As the first domestic HER2-targeted ADC drug in China, DV not only precisely kills tumor cells with HER2 over expression but also attacks adjacent cells with HER2 low expression through the bystander effect. Preclinical studies have also shown that the combination of DV with PD-1 inhibitor and trastuzumab can enhance anti-tumor activity. SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3ImmunotherapyADC

100 Deals associated with Disitamab Vedotin

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Carcinoma Metastatic in the Liver	China	RemeGen Co., Ltd.	30 Apr 2025
HER2 Positive Transitional Cell Carcinoma	China	RemeGen Co., Ltd.	31 Dec 2021
HER2-positive gastric cancer	China	RemeGen Co., Ltd.	08 Jun 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HER2-Low Breast Carcinoma	NDA/BLA	China	RemeGen Co., Ltd.	04 Jun 2025
HER2-Low Gastroesophageal Junction Cancer	Phase 3	China	RemeGen Co., Ltd.	15 May 2025
Gastroesophageal junction adenocarcinoma	Phase 3	China	RemeGen Co., Ltd.	25 Apr 2025
HER2 positive Gastroesophageal Junction Adenocarcinoma	Phase 3	China	RemeGen Co., Ltd.	07 Feb 2024
Metastatic urothelial carcinoma	Phase 3	United States	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Japan	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Argentina	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Australia	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Belgium	Seagen, Inc.	22 Sep 2023
Metastatic urothelial carcinoma	Phase 3	Brazil	Seagen, Inc.	22 Sep 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06378242 (Pubmed \| MedComm (2020)) Manual	Phase 1	HER2-Expressing Non-Muscle Invasive Bladder Neoplasms Induction HER2 Expression	9	Disitamab vedotin	uvgpmdpcee(slktrnxtnd) = none vrusjikhdl (rjhqjkxjdy ) View more	Positive	01 Jul 2025
NCT06420973 (ASCO2025) Manual	Phase 2	Platinum-Sensitive Ovarian Carcinoma \| Peritoneal Neoplasms \| Platinum-Sensitive Fallopian Tube Carcinoma HER2-expressing	15	Disitamab vedotin + Carboplatin ± bevacizumab	ifudyvjwpg(endthmmffd) = xqzacilkcx qsodvzvrcw (dxdzckjkbw ) View more	Positive	30 May 2025
				Disitamab vedotin + Carboplatin ± bevacizumab (HER2 IHC 1+)	ifudyvjwpg(endthmmffd) = dkwgejxgrc qsodvzvrcw (dxdzckjkbw )
NCT05980481 (ASCO2025) Manual	Phase 2/3	HER2-positive gastric cancer First line HER2-expressing	51	Disitamab vedotin (DV) (2.5 mg/kg) + toripalimab (Tor) + CAPOX (HER2-positive pts)	bvzdgacuwa(mgjbovzfeu) = ekjhlxhpcm kozrlyoxoj (neczzvofrc, 41.0 - 86.7) View more	Positive	30 May 2025
				Disitamab vedotin + toripalimab +trastuzumab (staring dose of 8 mg/kg followed by 6 mg/kg, Q3W) (HER2-positive pts)	bvzdgacuwa(mgjbovzfeu) = tsjfyoxqwp kozrlyoxoj (neczzvofrc, 56.6 - 96.2) View more
ChiCTR2300068270 (ASCO2025)	Phase 2	HER2 Positive Muscle Invasive Bladder Carcinoma Neoadjuvant HER2-overexpressing	18	RC48-ADC monotherapy	dfzixxrrjm(crlawvyeza) = ibmaxgwhzx qmegyxwfjl (jtbgcyouxb, 21.56 - 64.05) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Muscle Invasive Bladder Urothelial Carcinoma HER2-positive	217	Gemcitabine plus Cisplatin	ngylqyxifp(rpliyqiyzp) = vmgurpovte vmbyfvswmy (mglbpzswqt ) View more	Positive	30 May 2025
				RC48-ADC monotherapy	ngylqyxifp(rpliyqiyzp) = qfugfcvidh vmbyfvswmy (mglbpzswqt ) View more
NCT06749860 (RESOLUTION, ASCO2025)	Phase 2	metastatic non-small cell lung cancer HER2	9	RC48 + Tislelizumab + Bevacizumab	iunckoorxh(xosxbdsxsq) = naaphzumnl bkiklexjqn (fhzvtyoznf ) View more	Positive	30 May 2025
ChiCTR2500095450 (ASCO2025)	Not Applicable	Advanced HER2-Positive Breast Carcinoma HER2-positive	67	Disitamab vedotin (RC48)	hzjudovpvm(dqqbxulztm) = 23.88% of patients experienced grade ≥3 adverse events. The most common was decreased white blood cell count (8.95%) mhbxqfshoz (dklhntmigu )	Positive	30 May 2025
ASCO2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive \| HER2-low	28	Disitamab vedotin (RC48)	adbqlgdsjx(ojftwsuwti) = 13% nozzokqkfs (gxweehevos ) View more	Positive	30 May 2025
				RC48 in combination with other therapies
NCT06378242 (RC48-C029, ASCO2025)	Phase 1	HER2-Expressing Non-Muscle Invasive Bladder Neoplasms HER2-expressing	9	Intravesical disitamab vedotin (DV) 60 mg	dgzyktewad(kbwbufinnf) = 11.1% (1/9) qtzwdytpwd (kjzjowjwio ) View more	Positive	30 May 2025
				Intravesical disitamab vedotin (DV) 120 mg
ASCO2025	Not Applicable	Neoplasms HER2 expressing (IHC 1+, 2+,3+)	14	Disitamab Vedotin (RC48) monotherapy	ysyjoexxdr(mhagizdzjr) = qdjqphaoyh fqjkpfagsw (eaqbpjdiej ) View more	Positive	30 May 2025

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