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

Structure

Molecular FormulaC39H67N5O7

InChIKeyDASWEROEPLKSEI-UIJRFTGLSA-N

CAS Registry474645-27-7

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Gene Sequence

Sequence Code 616718896H

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Sequence Code 616718897L

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124

Clinical Trials associated with Disitamab Vedotin

NCT06105008 / Not yet recruitingPhase 2

An Randomized, Open-label, Multicenter Phase 2 Study Comparing the Efficacy and Safety of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin Monotherapy in Subjects With Endocrine-resistant Hormone Receptor-positive, HER2-Low Unresectable Locally Advanced or Metastatic Breast Cancer

This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast cancer.

Start Date20 Dec 2024

Sponsor / Collaborator

RemeGen Co., Ltd.

NCT06341400 / RecruitingPhase 1/2IIT

Perioperative Efficacy of RC48 Combined With Toripalimab in Treatment of Cisplatin Ineligible MIBC

A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy.

Start Date20 May 2024

Sponsor / Collaborator

Zhujiang Hospital of Southern Medical University

NCT06157892 / RecruitingPhase 1/2

A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer.
Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2.
This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them.
This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®.
This study will test how safe and how well DV, with or without tucatinib, is for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

Start Date20 May 2024

Sponsor / Collaborator

Seagen Inc.

[+1]

100 Clinical Results associated with Disitamab Vedotin

100 Translational Medicine associated with Disitamab Vedotin

100 Patents (Medical) associated with Disitamab Vedotin

Literatures (Medical) associated with Disitamab Vedotin

01 Feb 2024·EClinicalMedicine

Disitamab vedotin (RC48) plus toripalimab for HER2-expressing advanced gastric or gastroesophageal junction and other solid tumours: a multicentre, open label, dose escalation and expansion phase 1 trial

Article

Author: Qi, Changsong ; Wei, Jia ; Peng, Zhi ; Zhou, Jun ; Liu, Dan ; Li, Jian ; Shen, Lin ; Wang, Yakun ; Lu, Zhihao ; Fang, Jianmin ; Yuan, Jiajia ; Wang, Airong ; Gong, Jifang ; Zhang, Xiaotian ; Wang, Xicheng ; Zhang, Ruyan ; Lu, Ming ; Cao, Yanshuo

Background:

Although the antibody-drug conjugates (ADCs) have significantly improved the survival outcomes of patients with human epidermal receptor 2 (HER2)-expressing gastric or gastroesophageal junction (G/GEJ) cancer, the efficacy of ADC used as a single agent is limited. Therefore, it is necessary to investigate effective and safe combination regimens. Preclinical data indicated a synergetic antitumour effect of RC48 and programmed cell death protein 1 (PD-1) inhibitors. We aimed to evaluate the safety and efficacy of RC48 plus toripalimab in patients with HER2-expressing G/GEJ cancer and other solid tumours.

Methods:

This was a open-label, multicentre, phase 1 trial performed at three hospitals in China. Eligible patients had advanced G/GEJ cancer or other solid tumours with HER2 IHC≥1 or ISH positivity and were refractory to at least one line of treatment, or standard treatment was intolerable or unavailable for these patients. This study followed a "3 + 3" design with predefined RC48 dosages of 2.0 mg/kg and 2.5 mg/kg plus toripalimab 3 mg/kg, once every 2 weeks (q2w). The primary objectives were to evaluate the safety and determine the recommended phase II dose (RP2D), and the secondary objectives included assessing the pharmacokinetics (PK) and preliminary efficacy. This study was registered with ClinicalTrials.gov, NCT04280341.

Findings:

Between July 13, 2020 and August 30, 2022, 56 patients, including 30 patients with G/GEJ cancer and 26 patients with other solid tumours, were enrolled and received RC48 plus toripalimab (n = 7 for RC48 2.0 mg/kg, toripalimab 3 mg/kg, q2w; n = 49 for RC48 2.5 mg/kg, toripalimab 3 mg/kg, q2w). No dose-limiting toxic effects occurred. The RP2D was declared as RC48 2.5 mg/kg plus toripalimab 3 mg/kg, q2w. The most common grade 3 adverse events were a decreased neutrophil count (n = 13), and a decreased white blood cell count (n = 7). The efficacy assessment was completed for 52 patients. Among patients with G/GEJ cancer (n = 30), the confirmed objective response rate (ORR) was 43% (12/28, 95% CI 25, 63), median progression-free survival (PFS) was 6.2 months (95% CI 4.0, 6.9), median overall survival (OS) was 16.8 months (95% CI 7.2, NE). The ORR of patients with G/GEJ cancer receiving RP2D (n = 24) reached 50% (11/22, 95% CI 28, 72), with median PFS of 5.1 months (95% CI 1.4, 7.3) and median OS of 14.0 months (95% CI 6.3, NE). Among patients with G/GEJ cancer who received RP2D, a clinical benefit was observed in both HER2-positive and low HER2 expressing populations, with an ORR of 56% (5/9, 95% CI 21, 86) vs. 46% (6/13, 95% CI 19, 75), median PFS of 7.8 months (95% CI 0.9, NE) vs. 5.1 months (95% CI 1.2, 6.9), median OS of NE months (95% CI 4.3, NE) vs. 14.0 months (95% CI 5.1, NE), respectively. Antitumour activity was also observed for other solid tumours, including breast cancer (5/13) and endometrial carcinoma (1/1).

Interpretation:

Our findings suggested that RC48 plus toripalimab had a manageable safety profile and showed encouraging efficacy in pretreated patients with HER2-positive and low HER2-expressing G/GEJ cancer. The findings of our phase 1 clinical trial support further investigation of HER2-targeted ADC plus immunotherapy in HER2-expressing G/GEJ cancer and pancancer treatment in the future.

Funding:

Beijing Municipal Medical Research Institutes, Beijing Medical Research Institute (Z200015).

19 Jan 2024·Medicine

Long-term survival in a patient with multiple metastatic gastric cancer treated with PTX plus emvolimab and disitamab vedotin: case report and treatment experience: A case report

Article

Author: Yan, Zhiqiang ; Dai, Li ; Zhou, Yongjin ; Yang, Hongxin ; Wang, Haibin ; Zhang, Meifeng ; Jin, Xiangren ; Wang, Qian

Rationale::

Most Chinese patients with locally advanced gastric cancer at diagnosis have an overall 5-year survival rate of <50%. Surgical resection alone is not suitable for patients with locally advanced gastric cancer. Currently, comprehensive treatment is the focus of locally advanced gastric cancer.

Patients concerns::

The patient, a 56-year-old female, was admitted to the hospital because of “4 + months of double hydronephrosis found during a physical examination.” Who was admitted for computer tomography and gastroscopy examinations, and take pathological tissue specimens during endoscopic examination.

Diagnoses::

Computed tomography assessment indicated ulcerative gastric cancer with an abdominal implant, bladder, and bone metastases. An endoscopic examination revealed that the ulcer of the gastric angle was huge, and through relevant auxiliary examinations, the diagnosis of this disease is gastric cancer complicated with multiple metastases to bladder, rectum, lumbar spine, and peritoneum. Clinically diagnosed as cT4bN3M1.

Interventions::

The patient is currently undergoing first, second, and third line neoadjuvant therapy, combined with immunotherapy, targeted therapy, neoadjuvant intraperitoneal systemic chemotherapy, nutritional support, and other treatment plans.

Outcomes::

After 15 cycles of treatment, the progression-free survival had reached 15 months. The patient had an NRS2002 score of 1, an ECOG score of I, a quality of life score of 55, albumin of 35.27 g/L, and a decrease in abdominal and pelvic fluid accumulation and exudation compared to before.

Lessons::

We demonstrated high survival of almost 3 years in a patient with gastric cancer that was complicated by bone, peritoneal, rectal, and bladder metastases. The combination of immunotherapy, targeted therapy, and neoadjuvant intraperitoneal systemic chemotherapy, along with the maintenance of nutritional status and CTCs could be a valuable modality for the subsequent treatment and observation of similar patients.

01 Dec 2023·Cancer medicine

Real‐world effectiveness and safety of RC48‐ADC alone or in combination with PD‐1 inhibitors for patients with locally advanced or metastatic urothelial carcinoma: A multicenter, retrospective clinical study

Article

Author: Wang, Meng ; Li, Guangyuan ; Li, Yu ; Nie, Caiyun ; Zhang, Li ; Xu, Jingwei ; Chu, Xiufeng ; Guo, Yanwei ; Zhang, Hongqiao

Abstract:

Introduction:

Previous RC48 (Disitamab Vedotin) studies established that the safety and efficacy of RC48‐antibody–drug conjugate (ADC), either alone or combined with toripalimab, for metastatic urothelial carcinoma (mUC) patients exhibiting human epidermal growth factor receptor 2 (HER2)‐positive or even HER2‐negative status after standard chemotherapy failure.

Methods:

With locally advanced or metastatic urothelial carcinoma (la/mUC), patients who received RC48‐ADC monotherapy or a combination with programmed cell death protein 1 (PD‐1) inhibitors between August 2021 and October 2022 were enrolled in this retrospective observational study to evaluate the real‐world antitumor effectiveness and safety.

Results:

Among the 38 enrolled patients (29 males; median age 67.5 years [38–93]), 8 received RC48‐ADC monotherapy, while 30 received combination therapy. Initially, 63.2% (24/38) of the patients had received ≥1 line of prior treatment, and 63.2% (24/38) had visceral metastasis. UC of the bladder represented the majority type in 68.4% (26/38) of cases. By the data cutoff in March 2023, the overall objective response rate (ORR) was 63.2% (95% CI, 47.1%–79.2%), with a disease control rate (DCR) of 89.5% (95% CI, 79.3%–99.7%). Median follow‐up time was 10.6 months. The median progression‐free survival (PFS) was 8.2 months (95% CI, 5.9–10.5), with a 6‐month PFS rate of 63.2% and a 12‐month PFS rate of 34.1%. Median overall survival (OS) was not reached, with a 12‐month OS rate of 76.7%. The median duration of response was 7.3 months (95% CI, 4.6–10.0) among 24 patients evaluated as partial response (PR). The most common treatment‐related adverse events (TRAEs) included anemia (71.1%), anorexia (57.9%), asthenia (52.6%), hypoesthesia (52.6%), bone marrow suppression (47.4%), alopecia (47.4%), nausea (44.7%), proteinuria (36.8%), vomiting (34.2%), and hypoalbuminemia (31.6%). No patient experienced TRAEs of Grade ≥3. One patient had an immune‐related adverse event (irAE) of rash related to toripalimab.

Conclusions:

Both as monotherapy and in combination with PD‐1 inhibitors, RC48‐ADC exhibits promising effectiveness and manageable safety profile for mUC patients in real‐world settings.

News (Medical) associated with Disitamab Vedotin

13 Jun 2024

·www.fiercepharma.com

Pfizer expects 8 blockbuster cancer drugs to come from each of 4 focus areas: exec

Pfizer’s internal calculation suggests that “on paper” more than eight cancer drugs could become blockbusters, even though the company is only publicly targeting eight for now, Suneet Varma, Pfizer Oncology’s commercial president, said. During a recent investor event dedicated to the newly expanded oncology business, Pfizer unveiled a goal to have eight blockbuster cancer drugs by 2030 but fell short of naming specific products. That contribution of blockbusters will come from each of Pfizer Oncology’s four focused therapeutic areas, Suneet Varma, the division’s commercial president, told Fierce Pharma in an interview on the sidelines of American Society of Clinical Oncology annual meeting in Chicago. The four fields are breast, genitourinary, hematology and thoracic cancers. Pfizer’s internal calculation suggests that “on paper” more than eight cancer drugs could become blockbusters, but the New York pharma decided that eight is what it can stand by now, Varma added. Pfizer is betting big on oncology with the $43 billion acquisition of antibody-drug conjugate specialist Seagen last year. The heavy investment runs in parallel with some multiyear, multi-billion-dollar cost-cutting schemes as once high-flying sales from COVID products fell back to earth. Like many Big Pharma deals, the Seagen tie up came with its own consolidation, including a round of proposed layoffs in Switzerland and scrapping of a manufacturing facility in Washington. The oncology department won’t be affected by Pfizer’s latest multiyear cost reduction, or, as Varma put it: “there’s nothing more to be done in oncology.” The unit has already finished its organizational shuffles and cost containment efforts, including as part of the integration between Pfizer and Seagen, he said. Pfizer in December made oncology a separate division within the group and named then-oncology R&D head Chris Boshoff, M.D., Ph.D., as chief oncology officer. As to whether Pfizer Oncology might expand its commercial infrastructure further, Varma said, “We’re at the scale that we think we need to be.” Lung cancer reaching 'critical mass' Among the four focus areas, thoracic cancer, or mainly lung cancer, is currently the weakest link in Pfizer’s portfolio. But Varma argued that “lung will become its own franchise when it has that sufficient critical mass, which I think is upon us.” At the ASCO meeting a few days ago, Pfizer unveiled updated phase 3 results for the next-generation ALK inhibitor Lorbrena in newly diagnosed advanced ALK-positive non-small cell lung cancer. After five years, 60% of patients who got Lorbrena in the CROWN trial remained alive without disease progression, compared with just 8% for those who got Pfizer’s old ALK drug Xalkori. By investigators’ analysis, Lorbrena led to an 81% reduction in the risk of disease progression or death, or a 94% reduction in progression of brain metastases, over Xalkori. The progression-free survival results were compelling, and they compare well across trials with Roche’s current first-line standard of care, Alecensa, which reported a five-year overall survival rate of 62.5% in a phase 3 Xalkori head-to-head trial, Leerink Partners analysts said in a May 31 note. Since its first-line approval in March 2021, Lorbrena hasn’t really threatened Alecensa’s leading position in the ALK space. In 2023, Alecensa brought Roche 1.5 billion ($1.7 billion) Swiss francs in sales, while Lorbrena ginned up $539 million for Pfizer. An FDA approval in April also just moved Alecensa into postsurgical treatment of early-stage cancers, whereas Pfizer currently doesn’t have any studies geared toward that indication. One problem that has stopped more doctors from using Lorbrena in the first-line setting has to do with the drug’s neuro toxicities, including such side effects as seizures, changes in cognitive functions or mood, mental status, among others. Lorbrena’s best-in-class tumor progression results could persuade some doctors and patients to use it upfront, “although we do not expect it to rapidly become standard of care given the toxicity and tolerability profile, especially with no approved drugs to treat patients failing [Lorbrena],” the Leerink analysts noted. But Varma said Pfizer remains “very bullish” on Lorbrena. “Yes, there’s extra therapy management required,” Varma acknowledged. “But it’s worth it because years of life are being added to the patients.” “When we look at the data of people who switched [to Lorbrena], the outcomes are not as good,” Varma said. “So we believe firmly in your first chance is your best chance with Lorbrena.” Pfizer is applying to Lobrena some therapy management know-how brought over by the Seagen team, Varma noted. ADCs often come with complex side-effect profiles, and Seagen’s advice there could be helpful. Genitourinary franchise to surpass breast cancer portfolio The addition of Seagen and its ADC portfolio also allows Pfizer to expand commercial capabilities in biologics as the pharma giant’s cancer portfolio has historically been dominated by small molecules. The Pfizer-Seagen cross-boosting goes in both ways, Varma said. Pfizer has its large scale and sophistication in commercialization. Pfizer Oncology’s commercial and medical sales team was already double the size of Seagen’s before the combination, and the large pharma company is now applying its digital and publicist tools to all Seagen products. Legacy Seagen’s Astellas-partnered bladder cancer drug Padcev is among the top 10 brands that Pfizer Oncology is granting “disproportionate attention” for investment and resources, sales force prioritization and agency assistance, Varma said. Thanks to some impressive first-line bladder cancer data in a combination with Merck & Co.’s Keytruda, Padcev has swept the oncology community off its feet. And Pfizer has put the Nectin-4 ADC’s peak sales at more than $3 billion from around $700 million last year, Varma said. The Pfizer exec has divided up the genitourinary cancer team into two franchises reporting directly to him: one for prostate cancer that’s built around Astellas-partnered blockbuster drug Xtandi, and the other for bladder and kidney cancers. “By separating prostate from bladder and having two GU teams, they get tremendous focus,” Varma said. Because of Padcev’s great commercial prospect, Pfizer sees GU as becoming the oncology unit’s largest franchise supplanting breast cancer between now and 2030 despite Xtandi’s expected U.S. patent cliff in 2027. Besides Padcev and Xtandi, Pfizer also has the PARP inhibitor Talzenna, which is approved alongside Xtandi in certain prostate cancer patients. In the pipeline, the company has the EZH2 inhibitor mevrometostat, which is being moved into phase 3 trials in prostate cancer; and the subcutaneous PD-1 inhibitor sasanlimab, which is initially being angled toward bladder cancer. In addition, the HER2 ADC, disitamab vedotin, also has FDA breakthrough therapy designation in HER2-positive advanced bladder cancer. As to breast cancer, the fall of Pfizer’s largest oncology asset, Ibrance, is already on full display ahead of a 2027 patent cliff. Sales from the CDK4/6 inhibitor dropped 7% year over year in 2023 to $4.75 billion as the first-in-class med faces intense competition from rival drugs by Novartis and Eli Lilly. Still, Varma suggested that Ibrance has reached “stabilization.” The aging product for now owns about half of the CDK4/6 market share and about a third of new patient starts, he said. Ibrance still plays a “foundational role” that allows other Pfizer franchises to grow and launch, Varma said. But he declined to offer a projection on where and when Ibrance might eventually bottom out. Down the pipeline, Pfizer has highlighted the selective CDK4 inhibitor atirmociclib, which it believes could become a next-generation backbone in HR-positive breast cancer. There’s also vepdegestrant, an estrogen receptor protein degrader. What’s more, disitamab vedotin could have a place behind AstraZeneca and Daiichi Sankyo’s much-touted ADC Enhertu in the HER2 breast cancer space. And Seagen’s former CEO David Epstein has touted that Enhertu-relapsed setting as a blockbuster opportunity as well. Elsewhere in blood cancer, Pfizer is going toe-to-toe with Johnson & Johnson with their BCMA-directed T-cell engager for multiple myeloma. As J&J’s myeloma franchise is unrivaled for its modality breadth and commercial scale, Pfizer will face a tough fight even for a company of its size. Varma suggested that J&J’s franchise effect in myeloma won’t stop doctors from using Pfizer’s Elrexfio. And Seagen is here to help again, as Takeda-partnered Hodgkin lymphoma ADC Adcetris was the Seattle biotech’s biggest product before the merger. Despite his expressed confidence in Pfizer’s ability to reach eight cancer blockbusters by 2030, Varma again wouldn’t specify which drugs could reach that threshold. In a March note, Guggenheim analysts figured Padcev, Elrexfio, atirmociclib, vepdegestrant, mevrometostat, disitamab vedotin and sigvotatug vedotin (IB6 ADC) could make the cut.

Phase 3Drug ApprovalClinical ResultASCOBreakthrough Therapy

05 Jun 2024

·www.prnewswire.com

RemeGen Showcases Research Results at American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, Highlighting Its Prolific Innovation in Global Cancer Treatment

YANTAI, China, June 5, 2024 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, showcased its innovation in the field of global cancer treatment at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) held in Chicago from May 31-June 4, 2024, sharing major research results including its proprietary antibody drug conjugates (ADCs) Disitamab Vedotin (RC48) and RC88. RemeGen's innovative drugs featured in one Clinical Science Symposium, five Poster presentations, and ten online Abstracts at ASCO 2024, covering multiple cancer types including gastric and bladder cancer, and gynecological tumors in studies that included both monotherapy and combination therapies. Dr. Jianmin Fang, CEO of RemeGen, commented, "It is always such an honor to present our latest research findings on an internationally renowned stage such as ASCO Annual Meeting 2024. This not only demonstrates RemeGen's leading position in the field of antibody-drug conjugates in China but also proves our commitment to continuing our research efforts to provide effective treatment options for patients worldwide." Clinical Science Symposium First author Professor Song Li from Qilu Hospital of Shandong University gave an oral presentation at a Clinical Science Symposium at ASCO 2024 based on a randomized, controlled (RCT) multicenter, single-arm, Phase II trial investigating the efficacy of RemeGen's disitamab vedotin (RC48) combined with toripalimab and the oral fluoropyrimidine S-1 in first-line HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma. Poster Sessions First author Professor Sheng Xinan from Peking University Cancer Hospital presented RemeGen's poster session (Poster #263) of a Phase II study of neoadjuvant treatment with disitamab vedotin plus toripalimab in patients with HER2-expressing muscle-invasive bladder cancer (MIBC) focusing on the preliminary efficacy and safety results of RC48-C017. The standard of care for MIBC is neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy plus pelvic lymph node dissection (RC + PLND). Disitamab vedotin monotherapy, or combined therapy with toripalimab, showed promising anti-tumor activity in metastatic urothelial carcinoma. This Phase II trial aimed to evaluate the safety and efficacy of disitamab vedotin plus toripalimab as perioperative therapy in MIBC patients and the interim results presented at ASCO showed promising efficacy results with a manageable safety profile in operable MIBC patients. These results support further investigation for disitamab vedotin plus toripalimab in this population. Other poster presentations included a Phase II multi-center study in poster session (poster #311a) on adjuvant or rescue disitamab vedotin (RC48-ADC) for high-risk non-muscle invasive bladder cancer with HER2 expression; and a prospective, single-arm, single-center clinical study in poster session (poster #513a) on disitamab vedotin combined with toripalimab in patients with advanced penile cancer who have progressed on treatment or are intolerant to cisplatin chemotherapy. Online Abstract Publications Ten other online abstracts accepted by ASCO reflected results of RemeGen's RC48 and RC88 in bladder, breast, and GI cancers, demonstrating the Company's prolific innovation in global cancer treatment. About ASCO The ASCO 2024 meeting is the premier event for strategies to improve quality care in oncology. It provides superb panels featuring experts who are leading and implementing innovative programs focused on value. ASCO's diverse network of nearly 42,350 oncology professionals recognizes ASCO's dedication to providing the highest-quality resources in education, policy, the pioneering of clinical research, and above all, advancing the care for patients with cancer. About RemeGen Co. Ltd. Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: About Disitamab Vedotin (RC48) Disitamab Vedotin (RC48) is an investigational anti-HER2 antibody-drug conjugate targeting prevalent solid cancers with significant unmet medical needs and is the first domestically developed ADC to receive marketing approval in China. The company is implementing a differentiated development and commercial strategy for disitamab vedotin, including (i) gastric cancer (GC), (ii) urothelial carcinoma (UC), (iii) breast cancer (BC), and (iv) other HER2-expressing cancers. SOURCE RemeGen Co., Ltd

Clinical ResultASCOADCPhase 2

24 May 2024

·www.globenewswire.com

HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 23, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL and online. Results will be presented from the registration Phase II study of fruquintinib combined with sintilimab in 98 second-line or above patients with endometrial cancer (“EMC”) with pMMR status by central laboratory analysis, which supported the New Drug Application (NDA) filed in China. The primary endpoint was objective response rate (“ORR”) per RECIST v1.1, assessed by an independent review committee. The combination showed meaningful efficacy improvements in advanced EMC patients with pMMR status, regardless of prior bevacizumab treatment, with a manageable safety profile. The median follow-up time was 15.7 months. The ORR in 87 efficacy evaluable patients was 35.6% including two complete responses. Disease control rate (“DCR”) was 88.5%, and duration of response was not reached, with 80.7% remaining in response after nine months. Amongst the 98 patients, median progression-free survival (PFS) was 9.5 months, and median overall survival (OS) was 21.3 months. Further details are available in the abstract link below. Following the initial data of the FRUTIGA Phase III study of fruquintinib in second-line gastric cancer published during the February 2024 ASCO Plenary Series session, further updated efficacy data in key subgroups, and quality of life data will be presented at this year’s ASCO annual meeting. In addition, further data from the FRESCO and FRESCO-2 Phase III colorectal cancer studies, the study of surufatinib combinations in small cell lung cancer, and initial clinical data for the ERK1/2 inhibitor HMPL-295 will be presented. Details of the presentations, including links to available abstracts, are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES Fruquintinib plus Sintilimab in Treated Advanced Endometrial Cancer (EMC) Patients (Pts) with pMMR Status: Results From a Multicenter, Single-Arm Phase 2 StudyXiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China#5619Poster Session - Gynecologic CancerEfficacy and safety of fruquintinib in patients with metastatic colorectal cancer according to prior treatment sequence in the refractory setting: Results from FRESCO and FRESCO-2Tanios S. Bekaii-Saab, Mayo Clinic, U.S.#3579Poster Session - Gastrointestinal Cancer — Colorectal and AnalFruquintinib in Refractory Metastatic Colorectal CancerCathy Eng, Vanderbilt-Ingram Cancer Center, U.S.LinkEducation Session: New Drugs in Oncology: Incorporation Into PracticeUpdates on Abstract 438730: Fruquintinib Plus Paclitaxel Versus Paclitaxel as Second-Line Therapy for Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (FRUTIGA): A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 StudyFeng Wang, Sun Yat-Sen University Cancer Center, Guangzhou, ChinaLinkEducation Session: ASCO Plenary Series: Rapid Abstract UpdatesSurufatinib plus PD-1/L1 inhibitors as maintenance therapy following first line (1L) platinum-based chemotherapy combined with PD-1/L1 inhibitors in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC)Yi Hu,Chinese PLA General Hospital, Beijing, China#e15109Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor BiologyFirst-in-human study of HMPL-295, an ERK1/2 inhibitor, in patients with advanced solid tumors: dose-escalation results of monotherapyXianjun Yu,Fudan University Shanghai Cancer Center, Shanghai, China#e15112Publication Only: Developmental Therapeutics—Molecularly Targeted Agents and Tumor BiologyINVESTIGATOR-INITIATED STUDIES Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE)Chen Yajie, Zhang Zhen,Fudan University Shanghai Cancer Center, Shanghai, China#e15570Publication Only: Gastrointestinal Cancer—Colorectal and AnalA propensity score matched comparison of fruquintinib (FRU) versus FRU combined with PD-1 inhibitors for microsatellite stability (MSS) metastatic colorectal cancer: real-world dataLina He, Shuiping Tu,Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China#e15564 Publication Only: Gastrointestinal Cancer—Colorectal and AnalPhase Ib/II trial of hepatic arterial infusion chemotherapy (HAIC) in combination with fruquintinib as third-line therapy for refractory unresectable colorectal cancer liver metastasesZhu Xu,Peking University Cancer Hospital and Institute, Beijing, China#3561Poster Session - Gastrointestinal Cancer—Colorectal and AnalEfficacy and safety of fruquintinib plus trifluridine/tipiracil (TAS-102) as third-line treatment in patients with metastatic colorectal adenocarcinoma: Results from a single arm, phase 2, multicenter studyJianjun Peng,The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China#3536Poster Session - Gastrointestinal Cancer — Colorectal and AnalA phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic arteryinfusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases: An updated analysis of survivalLu Wang, Zhang Ti,Fudan University Shanghai Cancer Center, Shanghai, China#3543Poster Session - Gastrointestinal Cancer — Colorectal and AnalFruquintinib combined with sintilimab and SOX as conversion therapy for unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A single-arm, open-label, phase 2 clinical trialSuxia Luo, Fei Ma,Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China#e16021Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and HepatobiliaryShort-course radiotherapy (SCRT) followed by fruquintinib plus adebrelimab and CAPOX in the total neoadjuvant therapy of locally advanced rectal cancer (LARC): a multicenter, single-arm, open-label, phase II studyTao Zhang, Zhenyu Lin,Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaTPS3643Poster Session: Gastrointestinal Cancer — Colorectal and AnalFruquintinib plus capecitabine versus capecitabine as first-line maintenance treatment of metastatic colorectal cancer (mCRC): Update results from the randomized, controlled, phase Ib/II studyJunjie Peng, Wenhua Li,Fudan University Shanghai Cancer Center, Shanghai, China#3567Poster Session: Gastrointestinal Cancer — Colorectal and AnalEfficacy and safety of fruquintinib plus investigator's choice of chemotherapy as second-line therapy in metastatic colorectal cancer: updated results of a multicenter, single-arm, phase 2 trialYongshun Chen, Wensi Zhao,Renmin Hospital of Wuhan University, Wuhan, China#3571Poster Session: Gastrointestinal Cancer — Colorectal and AnalComparative analysis of first-line therapy with fruquintinib plus chemotherapy versus standard therapy in advanced metastatic colorectal cancer (mCRC): A prospective cohort study compared with propensity score matching (PSM) cohortFuxiang Zhou, Wenbo Wang,Zhongnan Hospital of Wuhan University, Wuhan, China#3591Poster Session: Gastrointestinal Cancer —Colorectal and AnalEfficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after developing resistance to several TKIs: A multi-centered retrospective studyLu Xie, Binghao Li,Peking University People’s Hospital, Beijing, China; The Second Affiliated Hospital Zhejiang University, Hangzhou, China#11528Poster Session: SarcomaDisitamab vedotin combined with fruquintinib in patients with HER2-expressing or HER2 mutation/amplified metastatic colorectal cancer refractory to at least two standard regimens: A prospective, exploratory, single-arm studyHui Xu,Zhongnan Hospital of Wuhan University. Wuhan, China#e15003Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor BiologySurufatinib combined with TAS-102 in third- or later-line therapy of patients with metastatic pancreatic cancer (mPDAC): an open-Label, single-Arm, phase II StudyDongsheng Zhang,Sun Yat-sen University Cancer Center, Guangzhou, China#e16297Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and HepatobiliarySurufatinib monotherapy or combined with vinorelbine as a late-line therapy in patients with refractory advanced non-small cell lung cancer (NSCLC)Yanfang Zheng,Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China#e20543Publication Only: Lung Cancer — Non-Small Cell MetastaticUpdated efficacy and safety results from the phase Ib/II study of surufatinib combined with camrelizumab and chemotherapy in patients with advanced colorectal cancerLiangjun Zhu, Sheng Li,Jiangsu Cancer Hospital, Nanjing, China#e15547Publication Only: Gastrointestinal Cancer — Colorectal and AnalPhase II study to evaluate surufatinib in patients with osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy: updated analysisXing Zhang,Sun Yat-sen University Cancer Center, Guangzhou, China#11539Poster Session: SarcomaEfficacy and safety of Surufatinib combined with EP regimen and Serplulimab in first-line treatment of NECTao Zhang, Zhenyu Lin,Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China#e15123Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor BiologyPerformance of surufatinib in treating advanced neuroendocrine neoplasms: Insights from a real-world studyQing Zhai, Linhui Zhu,Fudan University Shanghai Cancer Center; Shanghai Medical College, Fudan University, Shanghai, China#e15124Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor BiologyEpidemiological investigation of neuroendocrine differentiation in carcinomas: Focus on pancreatic and cholangiocarcinoma cohortsSusheng Shi, Yaru Wen,Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China#e16375Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and HepatobiliaryEfficacy and safety of surufatinib, toripalimab, nab-paclitaxel in combination with radiotherapy or surgery in the first-line treatment of esophageal squamous cell cancer: A single-centered prospective clinical trialFang Liu, Xiang Huang,Chinese PLA General Hospital, Beijing, China#e16047Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and HepatobiliaryEfficacy and safety of second-line treatment with surufatinib for anlotinib-resistant radioiodine-refractory differentiated thyroid cancer: An exploratory multicenter studyLibo Chen, Yang Wang,Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China#e15127Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib and HMPL-295, the further clinical development for fruquintinib, surufatinib and HMPL-295, its expectations as to whether any studies on fruquintinib, surufatinib and HMPL-295, would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib and HMPL-295, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib and HMPL-295 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of nab-paclitaxel, sintilimab, toripalimab, pemetrexed, platinum, etoposide or cisplatin as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon+44 (20) 7886 2500

Phase 2Clinical ResultPhase 3ASCONDA

100 Deals associated with Disitamab Vedotin

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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
HER2 positive Gastroesophageal Junction Adenocarcinoma	Phase 3	CN	RemeGen Co., Ltd.	07 Feb 2024
Metastatic Gastric Carcinoma	Phase 3	CN	RemeGen Co., Ltd.	04 Aug 2023
Biliary Tract Neoplasms	Phase 3	CN	RemeGen Co., Ltd.	23 Jun 2022
Breast Cancer	Phase 3	US	RemeGen Co., Ltd.	23 Jun 2022
Non-Small Cell Lung Cancer	Phase 3	CN	RemeGen Co., Ltd.	23 Jun 2022
Metastatic urothelial carcinoma	Phase 3	CN	RemeGen Co., Ltd.	14 Jun 2022
Urothelial Carcinoma of the Urinary Bladder	Phase 3	CN	RemeGen Co., Ltd.	14 Jun 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	CN	RemeGen Co., Ltd.	24 Mar 2021
HER2 positive Gastrooesophageal junction cancer	Phase 3	CN	RemeGen Co., Ltd.	06 Mar 2021
Locally advanced breast cancer	Phase 3	CN	RemeGen Co., Ltd.	29 Sep 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05661357 (ASCO2024) Manual	Phase 4	HER2 Positive Colorectal Cancer ERBB2 Mutation (Activating) \| HER2 Expression	11	Disitamab vedotin+fruquintinib	lktmqblaor(vwrwukvesw) = clvlgtedvb qwcjcwrldo (vnwkncjelw ) View more	Positive	24 May 2024
NCT05586061 (RCTS, ASCO2024) Manual	Phase 2	HER2-expressing Gastroesophageal Junction Adenocarcinoma \| HER2-positive gastric cancer First line PD-L1 Expression \| HER2 Overexpression	44	RC48	zhqhgunorg(ijwxlqftia) = gxnrrqbiut itpvvavoap (dxlgnhnfsj, 83.1 - 99.4) View more	Positive	24 May 2024
NCT05297552 (RC48-C017, ASCO2024) Manual	Phase 2	HER2 Positive Muscle Invasive Bladder Carcinoma Neoadjuvant HER2 Expression	44	Disitamab vedotin 2 mg/kg plus toripalimab 3 mg/kg	aqhnqzbwib(rgnnkhztui) = zdudsrtgnz szaqlyfltp (kwibfufjzh ) View more	Positive	24 May 2024
NCT06178601 (ASCO2024)	Phase 2	Metastatic urothelial carcinoma First line HER2 expression IHC 2+ or 3+ \| PD-L1 low expression	13	RC48-ADC combined with cadonilimab	jnhimgzmij(gpqanxrltu) = bltemisezp pbducofajq (qvnyvwltvd ) View more	Positive	24 May 2024
NCT04965519 (RC48-C018, ASCO2024)	Phase 2	Metastatic Carcinoma to the Uterine Cervix HER2	25	Disitamab Vedotin 2 mg/kg	qzuzihenyu(gacyzzhfkt) = usjhqviuam nuclrhswvl (eszmfwfwbu ) View more	Positive	24 May 2024
NCT06074484 (phase II study, ASCO2024)	Phase 2	HER2 Positive Muscle Invasive Bladder Carcinoma Adjuvant HER2 expression \| PD-L1 positive	18	Disitamab vedotin (RC48-ADC)	izpspdtaxg(bryovwebzf) = 2 cases observed (14.3%) jcrjazghms (srtlherayf ) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Advanced Urothelial Carcinoma	-	Disitamab vedotin plus PD-1 inhibitor	roclcoplmf(qchtekllbg) = nekwdaltsi talhfuyvzf (mjpbdjpaaz ) View more	-	24 May 2024
ASCO2024	Not Applicable	Advanced Urothelial Carcinoma	-	Chemotherapy plus ICI	ymafmmgjty(jfmgmqeuye) = tbaukflyht wsycjxkaig (powufivdef )	-	24 May 2024
NCT05911295 (DV-001, ASCO2024)	Phase 3	HER2 Positive Transitional Cell Carcinoma First line HER2	-	Disitamab vedotin with pembrolizumab	efqaytryrq(crgyjvcjfd) = kzxjzheajq vxhqwjrcnb (ekyvqmvihq ) View more	-	24 May 2024
NCT05495724 (TRUCE04, AUA2024)	Phase 2	Non-Muscle Invasive Bladder Neoplasms Her2-overexpressing	24	RC48 monotherapy	tnhxnowhww(yvzptavmwd) = Most common treatment-related adverse events were alopecia ttbcszkupx (mecjldvlja ) View more	Positive	01 May 2024
NCT05495724 (TRUCE04, AUA2024)	Phase 2	Non-Muscle Invasive Bladder Neoplasms Her2-overexpressing	24	RC48 combined with tislelizumab		Positive	01 May 2024
NCT03809013 \| NCT03507166 (RC48-C005 and RC48-C009, Pubmed)	Phase 2	HER2 Positive Transitional Cell Carcinoma HER2-positive	-	Disitamab Vedotin	sslpxgzmdn(ajdjzsvmid) = cucxfucewr blrgxwokdz (ubyezdnrpk, 40.6 - 60.3) View more	Positive	20 Apr 2024

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