RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN)

Structure/Sequence

Sequence Code 616718896H

Source: *****

Sequence Code 616718897L

Source: *****

148

Clinical Trials associated with Disitamab Vedotin

ChiCTR2500096933

/ SuspendedPhase 2IIT

Efficacy and safety of RC48 combined with carboplatin in first-line chemotherapy for advanced ovarian cancer

Start Date10 Feb 2025

Sponsor / Collaborator

Zhejiang Cancer Hospital

NCT06642545

/ RecruitingPhase 2

A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

Start Date10 Feb 2025

Sponsor / Collaborator

RemeGen Co., Ltd.

ChiCTR2500095968

/ SuspendedPhase 2IIT

A prospective multicenter clinical trial on the efficacy and safety of RC48-ADC (disitamab vedotin) combined with toripalimab in the treatment of HER2 positive locally advanced or metastatic scrotal Extramammary Paget's disease

Start Date20 Jan 2025

Sponsor / Collaborator

Fujian Medical University

100 Clinical Results associated with Disitamab Vedotin

100 Translational Medicine associated with Disitamab Vedotin

100 Patents (Medical) associated with Disitamab Vedotin

661

Literatures (Medical) associated with Disitamab Vedotin

01 Mar 2025·ANNALS OF ONCOLOGY

Disitamab vedotin plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (RC48-C014): a phase Ib/II dose-escalation and dose-expansion study

Article

Author: Li, S M ; Cui, C L ; Guo, J ; Zhou, L ; Yan, X Q ; Si, L ; Yang, K W ; Li, J ; He, Z S ; Tang, B X ; Zhang, S ; Chi, Z H ; Liu, Y Q ; Guo, H Q ; Sheng, X N ; Xu, H Y

BACKGROUND:

HER2-targeted antibody-drug conjugates (ADCs) such as disitamab vedotin (DV) and trastuzumab deruxtecan (T-Dxd) have emerged as effective treatment options and received regulatory approvals for HER2 expressing locally advanced or metastatic urothelial carcinoma (la/mUC). In addition, ADCs in combination with immunotherapy have demonstrated anti-tumor activity. The current study aimed to evaluate the combination of DV and toripalimab in patients with la/mUC.

PATIENTS AND METHODS:

This open-label phase 1b/2 study enrolled patients with untreated or chemo-refractory la/mUC. During the dose escalation phase, DV was administered at escalating doses of 1.5 and 2.0 mg/kg in combination with toripalimab 3.0 mg/kg once every two weeks. Primary endpoints were safety and the recommended phase 2 dose (RP2D). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).

RESULTS:

From August 2020 to December 2021, a total of forty-one patients were enrolled, including six in the dose-escalation phase, and thirty-five in the dose-expansion phase. Sixty-one percent of patients were treatment naïve. No dose-limiting toxicity was observed. The RP2D was determined as DV (2.0 mg/kg) plus toripalimab (3.0 mg/kg). By the data cutoff date of March 1, 2024, the confirmed ORR was 73.2%. The median PFS was 9.3 months, and the median OS was 33.1 months. The most common treatment-related adverse events (TRAEs) were aspartate aminotransferase increased (65.9%), alanine aminotransferase increased (63.4%), and peripheral sensory neuropathy (63.4%). Grade 3 or higher TRAEs occurred in 51.2% of patients, with the most common being gamma-glutamyltransferase increased (12.2%), asthenia (9.8%), and alanine aminotransferase increased (7.3%). One treatment-related death (due to pneumonitis) was reported.

CONCLUSIONS:

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.

01 Mar 2025·Translational Oncology

Disitamab vedotin in preclinical models of HER2-positive breast and gastric cancers resistant to trastuzumab emtansine and trastuzumab deruxtecan

Article

Author: Isola, Jorma ; Barok, Mark ; Honkamaki, Cilla ; Laakkonen, Pirjo ; Joensuu, Heikki ; Leyton, Jeffrey V ; Vereb, György ; Pourjamal, Negar ; Le Joncour, Vadim

BACKGROUND:

Most HER2-positive breast or gastric cancers eventually become resistant to the approved anti-HER2 antibody-drug conjugates (ADC) trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd). Disitamab vedotin (DV) is a novel anti-HER2 ADC that binds to a different epitope on HER2 compared to trastuzumab. We assessed the efficacy of DV in breast and gastric cancer cell lines and xenografts, including tumor models resistant to T-DM1 and T-DXd. Additionally, we investigated whether combining two anti-HER2 ADCs could enhance the efficacy of the individual ADCs.

METHODS:

The efficacy of DV, T-DM1, and T-DXd, both as single agents and in combinations, was assessed using an AlamarBlue cell proliferation assay in HER2-positive breast and gastric cancer cell lines, including those resistant to T-DM1 and T-DXd. The efficacy of DV was evaluated also in breast and gastric cancer SCID mouse xenografts that had progressed on T-DM1 and/or T-DXd. ADC combinations were tested in breast and gastric cancer xenografts.

RESULTS:

DV was effective in cell lines resistant to T-DM1 and/or T-DXd, and it inhibited the growth of breast and gastric cancer xenografts that had progressed on T-DM1 and/or T-DXd. The combinations of DV plus T-DM1 and DV plus T-DXd showed greater efficacy than the corresponding single agents in both breast and gastric cancer cell lines and xenografts.

CONCLUSIONS:

DV was effective in treating breast and gastric cancer xenograft tumors resistant to T-DM1 and/or T-DXd. The combination of DV with T-DM1 or T-DXd demonstrated promising activity.

03 Feb 2025·ANGEWANDTE CHEMIE-INTERNATIONAL EDITION

Benzyl Ammonium Carbamates Undergo Two‐Step Linker Cleavage and Improve the Properties of Antibody Conjugates

Article

Author: Li, Xiaoyi ; Schnermann, Martin J. ; Patel, Nimit L. ; Kalen, Joseph

Abstract:

Targeted payload delivery strategies, such as antibody‐drug conjugates (ADCs), have emerged as important therapeutics. Although considerable efforts have been made in the areas of antibody engineering and labeling methodology, improving the overall physicochemical properties of the linker/payload combination remains an important challenge. Here we report an approach to create an intrinsically hydrophilic linker domain. We find that benzyl α‐ammonium carbamates (BACs) undergo tandem 1,6–1,2‐elimination to release secondary amines. Using a fluorogenic hemicyanine as a model payload component, we show that a zwitterionic BAC linker improves labeling efficiency and reduces antibody aggregation when compared to a commonly used para‐amino benzyl (PAB) linker as well as a cationic BAC. Cellular and in vivo fluorescence imaging studies demonstrate that the model payload is specifically released in antigen‐expressing cells and tumors. The therapeutic potential of the BAC linker strategy was assessed using an MMAE payload, a potent microtubule‐disrupting agent frequently used for ADC applications. The BAC‐MMAE combination enhances labeling efficiency and cellular toxicity when compared to the routinely used PAB‐Val‐Cit ADC analogue. Broadly, this strategy provides a general approach to mask payload hydrophobicity and improve the properties of targeted agents.

News (Medical) associated with Disitamab Vedotin

06 Mar 2025

·www.prnewswire.com

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyPriority Review

15 Feb 2025

·pipelinereview.com

RemeGen Announced Highly Encouraging Data from the Phase II Clinical Trial Evaluating Disitamab Vedotin plus Immunotherapy as Perioperative Regimen for Bladder Cancer

YANTAI, China I February 15, 2025 I On the morning of February 14, 2025 (UTC-8), at the ongoing 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) held in San Francisco, USA, Professor Xinan Sheng from Peking University Cancer Hospital delivered the latest efficacy and safety data from the phase II clinical trial (NCT05297552, Study ID: RC48-C017) of Disitamab Vedotin (DV) in combination Toripalimab as the neoadjuvant therapy for HER2-expressing muscle-invasive bladder cancer (MIBC) in an oral presentation. This marks the first public disclosure of results from a prospective clinical study investigating an ADC drug in combination with an immunotherapy as a perioperative therapy for MIBC. The pathological complete response (pCR) rate reached an impressive 63.6%, which is a breakthrough improvement compared with traditional neoadjuvant chemotherapies (36%-42%).ASCO GU is one of the top urologic oncology conferences that leading experts worldwide in this field attend. The NCT05297552 study explored the synergy between the targeted therapy and immunotherapy in the perioperative setting for MIBC. Specifically, it assessed the safety and efficacy of the novel combination therapy featuring DV, a HER2-targeting ADC drug initially developed by RemeGen Co., Ltd. (RemeGen), and Toripalimab, a PD-1 inhibitor. In May 2024, based on the NCT05297552 study, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted breakthrough therapy designation to DV. The preliminary results of this study were presented at the 2024 ASCO Annual Meeting and led to widespread attention and discussion among experts worldwide. The updated data at ASCO GU further validated the clinical benefits of this therapeutic approach. In the NCT05297552 study, 47 eligible patients (10.6% with HER2 IHC 1+, 57.4% with IHC 2+, and 31.9% with IHC 3+) received the investigational neoadjuvant therapy, among whom 33 patients underwent radical cystectomy and pelvic lymph node dissection (RC + PLND). As of the data cut-off date on December 3, 2024, the study demonstrated promising efficacy and manageable safety profiles: RemeGen is advancing research on targeted and personalized therapies for bladder cancer through indication expansion and therapy innovation of DV, aiming to provide more potent treatment options for patients worldwide. Currently, studies are in-progress to explore the feasibility of expanding DV-based regimens from later-line to front-line treatment for locally advanced or metastatic urothelial cancer. There are also plans to broaden the research of DV as a neoadjuvant therapy for MIBC to the entire perioperative period and investigate the synergy between DV and chemotherapy or other immunotherapies in treating urothelial cancer. SOURCE: RemeGen Co.

Clinical ResultImmunotherapyASCOPhase 2Breakthrough Therapy

15 Feb 2025

·www.prnewswire.com

ASCO GU｜RemeGen Announced Highly Encouraging Data from the Phase II Clinical Trial Evaluating Disitamab Vedotin plus Immunotherapy as Perioperative Regimen for Bladder Cancer

YANTAI, China, Feb. 15, 2025 /PRNewswire/ -- On the morning of February 14, 2025 (UTC-8), at the ongoing 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) held in San Francisco, USA, Professor Xinan Sheng from Peking University Cancer Hospital delivered the latest efficacy and safety data from the phase II clinical trial (NCT05297552, Study ID: RC48-C017) of Disitamab Vedotin (DV) in combination Toripalimab as the neoadjuvant therapy for HER2-expressing muscle-invasive bladder cancer (MIBC) in an oral presentation. This marks the first public disclosure of results from a prospective clinical study investigating an ADC drug in combination with an immunotherapy as a perioperative therapy for MIBC. The pathological complete response (pCR) rate reached an impressive 63.6%, which is a breakthrough improvement compared with traditional neoadjuvant chemotherapies (36%-42%). ASCO GU is one of the top urologic oncology conferences that leading experts worldwide in this field attend. The NCT05297552 study explored the synergy between the targeted therapy and immunotherapy in the perioperative setting for MIBC. Specifically, it assessed the safety and efficacy of the novel combination therapy featuring DV, a HER2-targeting ADC drug initially developed by RemeGen Co., Ltd. (RemeGen), and Toripalimab, a PD-1 inhibitor. In May 2024, based on the NCT05297552 study, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) granted breakthrough therapy designation to DV. The preliminary results of this study were presented at the 2024 ASCO Annual Meeting and led to widespread attention and discussion among experts worldwide. The updated data at ASCO GU further validated the clinical benefits of this therapeutic approach. In the NCT05297552 study, 47 eligible patients (10.6% with HER2 IHC 1+, 57.4% with IHC 2+, and 31.9% with IHC 3+) received the investigational neoadjuvant therapy, among whom 33 patients underwent radical cystectomy and pelvic lymph node dissection (RC + PLND). As of the data cut-off date on December 3, 2024, the study demonstrated promising efficacy and manageable safety profiles: The pathological complete response (pCR) rate reached an impressive 63.6% (95% CI: 45.1% - 79.6%), nearly doubling that observed with traditional neoadjuvant chemotherapies (36%-42%). The pathological response rate was 75.8% (95% CI: 57.7% - 88.9%). The study showed that for patients with baseline clinical stage of T2N0, the postoperative pCR rate reached 85.7%. A pCR rate of 55.6% was also achieved in patients with other pathological subtypes of urothelial carcinoma at baseline. Patients benefited significantly regardless of PD-L1 positive/negative and regardless of HER2 expression status (IHC 1+/2+/3+), among whom the pCR rate stood at 84.6% for HER2 IHC 3+ patients. The 12-month event-free survival (EFS) rate of all patients who underwent radical cystectomy was 92.5%, and the 18-month EFS rate was 85.9%. The therapy exhibited a manageable safety profile. The incidence of grade 3 or higher treatment-emergent adverse events (TEAEs) was only 27.7%, notably lower than the traditional chemotherapy regimen (40%-50%), suggesting a favorable tolerability. RemeGen is advancing research on targeted and personalized therapies for bladder cancer through indication expansion and therapy innovation of DV, aiming to provide more potent treatment options for patients worldwide. Currently, studies are in-progress to explore the feasibility of expanding DV-based regimens from later-line to front-line treatment for locally advanced or metastatic urothelial cancer. There are also plans to broaden the research of DV as a neoadjuvant therapy for MIBC to the entire perioperative period and investigate the synergy between DV and chemotherapy or other immunotherapies in treating urothelial cancer. 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 ResultASCOBreakthrough TherapyPhase 2Immunotherapy

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
HER2 Positive Transitional Cell Carcinoma	CN	RemeGen Co., Ltd.	31 Dec 2021
HER2-positive gastric cancer	CN	RemeGen Co., Ltd.	08 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Carcinoma Metastatic in the Liver	NDA/BLA	CN	RemeGen Co., Ltd.	15 Oct 2024
HER2 positive Gastroesophageal Junction Adenocarcinoma	Phase 3	CN	RemeGen Co., Ltd.	07 Feb 2024
Locally Advanced Urothelial Carcinoma	Phase 3	US	Seagen Inc.	22 Sep 2023
Locally Advanced Urothelial Carcinoma	Phase 3	AR	Seagen Inc.	22 Sep 2023
Locally Advanced Urothelial Carcinoma	Phase 3	AU	Seagen Inc.	22 Sep 2023
Locally Advanced Urothelial Carcinoma	Phase 3	BR	Seagen Inc.	22 Sep 2023
Locally Advanced Urothelial Carcinoma	Phase 3	CA	Seagen Inc.	22 Sep 2023
Locally Advanced Urothelial Carcinoma	Phase 3	CL	Seagen Inc.	22 Sep 2023
Locally Advanced Urothelial Carcinoma	Phase 3	FR	Seagen Inc.	22 Sep 2023
Locally Advanced Urothelial Carcinoma	Phase 3	IL	Seagen Inc.	22 Sep 2023

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05297552 (RC48-C017, ASCO_GU2025) Manual	Phase 2	HER2 Positive Muscle Invasive Bladder Carcinoma Adjuvant \| Neoadjuvant HER2 Expression	47	Disitamab vedotin+toripalimab	qujgezlhuc(ojlhtdlbpa) = mzmrnkabxx bnpfacdcge (xllfwvdged, 45.1 - 79.6) View more	Positive	13 Feb 2025
				Disitamab vedotin+toripalimab (PD-L1-positive)	qujgezlhuc(ojlhtdlbpa) = cbfiwkegxa bnpfacdcge (xllfwvdged )
ASCO_GU2025 Manual	Not Applicable	HER2 Positive Muscle Invasive Bladder Carcinoma Neoadjuvant HER2 Positive	28	Toripalimab + Disitamab vedotin	ffffeqjzxp(mntjcihrck) = afrvdhmrag dfunokhpsd (jvrzeotkka ) View more	Positive	13 Feb 2025
NCT04264936 (RC48-C014, PRNewswire) Manual	Phase 1/2	Locally Advanced Urothelial Carcinoma \| Metastatic urothelial carcinoma HER2 Expression	41	Disitamab Vedotin + Toripalimab	fzgyjesrsd(hbhevcqhts) = djtbmbqity xmjnazwkwy (kpjaezvovo ) View more	Positive	08 Jan 2025
				Disitamab Vedotin + Toripalimab (chemotherapy-naïve patients)	fzgyjesrsd(hbhevcqhts) = mlpvhqtucx xmjnazwkwy (kpjaezvovo )
ESMO_ASIA2024 \| NEWS Manual	Not Applicable	Ovarian Cancer \| Endometrial Carcinoma \| Uterine Cervical Cancer HER2 Positive	27	Total	wdvultntda(kuqqipanqi) = zxfkprccxh kmfslazvlq (wtafcmyddv ) View more	Positive	08 Dec 2024
				Disitamab vedotin monotherapy (ovarian cancer)	wdvultntda(kuqqipanqi) = lyrqfbvywv kmfslazvlq (wtafcmyddv ) View more
ESMO_ASIA2024 Manual	Not Applicable	Transitional Cell Carcinoma HER2 low expression	27	RC48-ADC ± PD-1 inhibitor	vgmzrwqivc(ditnvnabwc) = ezfofxwqrj tdmeijldno (cxtoledrad ) View more	Positive	07 Dec 2024
NCT03500380 (RC48-C006, SABCS2024 \| PRNewswire) Manual	Phase 2/3	Advanced HER2-Positive Breast Carcinoma Second line HER2 Positive	104	Disitamab vedotin	gzymegpgsy(nwcqazykjw) = jdbyidajlc uvlqzvgmzx (xubmmafniq ) View more	Positive	26 Nov 2024
				Lapatinib+Capecitabine	gzymegpgsy(nwcqazykjw) = pckobkrgcq uvlqzvgmzx (xubmmafniq ) View more
Pubmed Manual	Not Applicable	HER2-Low Breast Carcinoma \| HER2 Positive Breast Cancer HER2 Positive	154	RC48-ADC	sfxboejkyl(bneuaomdwn) = qrrpfgvbeq iqbyvypyky (bzwezwblhv ) View more	Positive	08 Nov 2024
				RC48-ADC (HER2-positive)	sfxboejkyl(bneuaomdwn) = xvczjsmewv iqbyvypyky (bzwezwblhv ) View more
NCT03556345 (RC48-C008, NEWS) Manual	Phase 2	Gastrooesophageal junction cancer \| Stomach Cancer	127	Disitamab vedotin 2.5 mg/kg	chxajslzyj(jaungfqikx) = fahzyldwnz rdumyproqc (cldrwqlugn, 11.8 - 25.9) View more	Positive	05 Oct 2024
				Disitamab vedotin 2.5 mg/kg (接受2线)	chxajslzyj(jaungfqikx) = hkqhynttwq rdumyproqc (cldrwqlugn )
NCT05331326 (ESMO2024) Manual	Phase 2	HER2 Positive Breast Cancer HER2-positive \| PAM pathway activation	61	Disitamab vedotin (RC48)	tkcbhjcocx(nhsjkbflhl) = biihdyjlun ymifytdhxc (bnywjovwvm ) View more	Positive	16 Sep 2024
				Disitamab vedotin (HER2-positive)	tkcbhjcocx(nhsjkbflhl) = kqbcbrnuik ymifytdhxc (bnywjovwvm ) View more
NCT04264936 (RC48-C014, ESMO2024) Manual	Phase 1/2	Transitional Cell Carcinoma HER-2 expressing \| PD-L1 positive	41	Disitamab Vedotin (DV) + Toripalimab (T)	tprwecafbg(altdbczjcp) = gamma-glutamyltransferase increased (12.2%), asthenia (9.8%), hypertriglyceridaemia (7.3%), and alanine aminotransferase increased (7.3%). dkpygjwmwx (nbudtfxggv ) View more	Positive	15 Sep 2024

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