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

Structure/Sequence

Sequence Code 315610456H

Source: *****

120

Clinical Trials associated with Envafolimab

NCT07159191

/ Not yet recruitingPhase 2IIT

This is a Single-center, Single-arm, Phase II, Prospective Clinical Study Planning to Enroll 30 Patients With Advanced Renal Cell Carcinoma. Eligible Patients, After Signing the Informed Consent Form and Passing the Screening Process, Will Receive Envafolimab + Axitinib Treatment Until Disease Progression or Intolerable Toxicity (Treatment Duration Not Exceeding 24 Months). Clinical Tumor Imaging Assessments Will be Conducted Every 12 Weeks During the Treatment Process According to the RECIST V1.1 Criteria. Safety Will be Assessed Using CTCAE 5.0, With Adverse Events Recorded From Each Treatme

Introduction:
This document explains a clinical research study conducted at Peking Union Medical College Hospital. The study aims to evaluate a new combination treatment - Envafolimab (an immunotherapy) and Axitinib (a targeted therapy) - for patients newly diagnosed with advanced kidney cancer (specifically, clear cell Renal Cell Carcinoma or RCC). This information is designed to help patients, their families, and healthcare providers understand the study's purpose, procedures, potential benefits and risks, and what participation involves.
1. What is the Study About?
* The Problem: Advanced kidney cancer (RCC) that has spread (metastatic) or cannot be removed by surgery (unresectable) is challenging to treat. While treatments exist, researchers are always looking for more effective and manageable options, especially for patients who haven't had prior systemic (whole-body) anti-cancer therapy.
* The New Approach: This study combines two types of drugs:
* Envafolimab: An "immunotherapy" drug given as an injection under the skin (subcutaneous). It works by blocking a protein called PD-L1 on cancer cells or immune cells. Blocking PD-L1 helps the patient's own immune system recognize and attack the cancer cells more effectively.
* Axitinib: A "targeted therapy" drug taken as a pill twice daily. It works by blocking signals (VEGF receptors) that cancer cells use to grow new blood vessels, essentially starving the tumor of its blood supply.
* The Goal: To find out if giving Envafolimab and Axitinib together is safe and effective as the first treatment for patients with advanced kidney cancer. Researchers want to see how well the combination shrinks tumors, controls the cancer, and how long patients live without their cancer getting worse, while carefully monitoring side effects.
* Study Design:
* Phase II: This is an early stage of testing in patients, focusing mainly on how well the treatment works and its safety profile in a specific group.
* Single-Arm: All participants in this study will receive the same combination treatment (Envafolimab + Axitinib). There is no separate group receiving a different treatment or placebo for comparison in this particular study.
* Single-Center: Currently being run at Peking Union Medical College Hospital (but could potentially expand).
* Participants: Plans to enroll about 30 patients.
* Treatment Duration: Patients receive treatment as long as it's working (tumor isn't growing) and they can tolerate the side effects, for up to a maximum of 2 years.
2. Key Information for Patients & Families:
* Who Might Qualify? You may be eligible to participate if you:
* Are between 18 and 75 years old.
* Have been diagnosed with advanced clear cell kidney cancer (unresectable or metastatic).
* Have NOT received any prior systemic anti-cancer treatment (like chemotherapy, immunotherapy, or other targeted therapies) for your advanced kidney cancer.
* Have tumors that can be measured on scans (CT or MRI).
* Are relatively active and able to care for yourself (ECOG performance status 0 or 1: meaning you are either fully active or restricted in physically strenuous activity but ambulatory and able to do light work).
* Have adequate organ function (healthy enough bone marrow, liver, kidneys, heart) as determined by blood tests.
* Are expected to live at least 6 more months.
* Understand the study and agree to follow the procedures and attend all visits.
* Who Would Not Qualify? You would likely not be eligible if you:
* Have another active cancer besides the kidney cancer being studied.
* Have had previous systemic treatment for your advanced kidney cancer.
* Have known severe allergies to similar drugs or components of Envafolimab/Axitinib.
* Have an active autoimmune disease needing strong medication (like high-dose steroids or immunosuppressants) within the last 2 years. (Hormone replacements like thyroid meds are okay).
* Are taking high-dose steroids (except inhaled/nasal) or other immune-suppressing drugs shortly before starting.
* Are using traditional Chinese medicine or immunomodulators within 2 weeks before joining.
* Have serious uncontrolled heart problems (like recent heart attack, severe heart failure, unstable angina, significant irregular heartbeats).
* Have uncontrolled fluid build-up needing drainage (like large amounts of ascites or pleural effusion).
* Are pregnant, breastfeeding, or unwilling to use highly effective contraception during the study and for 6 months after.
* Have significant psychiatric, substance abuse, or other medical/social issues that the research team believes would interfere with the study.

Start Date01 Sep 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT07142863

/ Not yet recruitingPhase 2IIT

Single-arm Prospective Clinical Study of PD-L1 Antibody Envafolimab Combined With Neoadjuvant Chemotherapy in Patients With Stage IIb Resectable Osteosarcoma

Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Postoperatively, patients can regain functional mobility through prosthetic implantation and artificial joint reconstruction, thereby preventing premature loss of mobility in young patients. This study aims to explore the efficacy and safety of neoadjuvant treatment with the PD-L1 antibody envafolimab in combination with standard chemotherapy in patients with resectable stage IIb osteosarcoma, and to assess whether this combined regimen can increase the proportion of patients achieving complete tumor resection.

Start Date25 Aug 2025

Sponsor / Collaborator

Shanghai First People's Hospital

NCT06772233

/ Not yet recruitingPhase 2IIT

A Phase II, Open-label, Multicenter, Randomized Controlled Clinical Trial Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment.

This study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to physician's choice in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.

Start Date30 Jul 2025

Sponsor / Collaborator

Peking University

100 Clinical Results associated with Envafolimab

100 Translational Medicine associated with Envafolimab

100 Patents (Medical) associated with Envafolimab

Literatures (Medical) associated with Envafolimab

01 Jan 2026·JOURNAL OF PHARMACEUTICAL SCIENCES

Subcutaneously administered anti-PD-(L)1 antibodies are predominantly absorbed via the lymphatic system, resulting in high drug exposure to draining lymph nodes

Article

Author: Fei, Xiaoxuan ; Sun, Lie ; Yan, Simin ; Li, Li ; Zou, Jianjun ; Ge, Weihong ; Hu, Luojuan ; Han, Sifei ; Zhang, Huimin ; Pei, Junyi

Compared to classic intravenous (IV) administration, subcutaneous (SC) delivery of monoclonal antibodies (mAbs) offers new opportunities to improve patient compliance and healthcare efficiency. However, insufficient understanding of drug absorption process following SC administration, particularly the role of lymphatic transport, may hinder the development of SC formulations for mAbs. The current study aimed to examine the absorption route of widely used anti-PD-(L)1 mAbs following SC injection, and four marketed products (Pembrolizumab, Tislelizumab, Envafolimab, Sugemalimab) were selected as the model drugs. In the thoracic lymph duct-cannulated rat model, all mAbs were found to be primarily absorbed via the lymphatics following SC injection, with 63.1-72.0 % of the administered dose recovered in the thoracic lymph, contributing to >80 % of SC bioavailability. This absorption pattern also resulted in elevated exposure of mAbs in draining lymph nodes (an order of magnitude higher drug concentrations compared to the systemic drug exposure). In addition, markedly different lymphatic absorption profiles were observed following SC administration at different sites, reflecting specific draining routes associated with certain anatomical regions in the rat. Our data suggested that the food pad is likely the optimal SC injection site for quantitative studies of lymphatic transport, whereas injection to the lower hind leg (a common SC injection site in previous studies) appeared to underestimate the absolute extent of lymphatic drug transport in the thoracic lymph duct-cannulated rat model, as lymphatic drainage from this region partially bypasses the cannulation site, leading to incomplete collection of draining lymph.

01 Sep 2025·JOURNAL OF CONTROLLED RELEASE

A super-long-acting anti-PD-L1 nanobody fused to elastin-like polypeptide for triple-negative breast cancer immunotherapy

Article

Author: Gao, Weiping ; Yang, Zhaoying ; Zhang, Fan ; Sun, Yuanzi ; Yao, Qiongqiong

The limited tumor penetration of monoclonal antibodies or the rapid renal clearance of nanobodies hamper their application in cancer immunotherapy. Through genetic engineering, we fuse a thermosensitive elastin-like polypeptide of ELP(V) with a nanobody of KN035 that binds specifically to human programmed cell death protein ligand 1 (PD-L1) to generate a conjugate of KN035-ELP(V) for triple-negative breast cancer (TNBC) therapy. The high affinity of KN035-ELP(V) enables it to efficiently block the interaction of PD1 and PD-L1. A single intraperitoneal administration of KN035-ELP(V) leads to the in situ generation of a sustained-release depot, showing a circulating half-life that is 276.4-fold and 5.1-fold longer than those of KN035 and KN035 fused with fragment crystallizable (KN035-Fc), respectively. Additionally, KN035-ELP(V) outperforms KN035 and KN035-Fc in term of accumulation and penetration in tumor tissue. Compared to KN035 and KN035-Fc treatments, a single injection of KN035-ELP(V) induces a durable and efficient antitumor immunity in TNBC-bearing mice, resulting in improved anti-tumor efficacy with reduced adverse effects. Therefore, KN035-ELP(V) is promising as a super-long-acting anti-PD-L1 nanobody for efficient cancer immune checkpoint blockade therapy.

01 Sep 2025·ONCOLOGIST

Combination therapy for platinum-resistant ovarian cancer: a novel at-home regimen with envafolimab, lenvatinib, and etoposide

Article

Author: Ji, Feng ; Lin, Hao ; Ding, Bo ; Shen, Yang ; Xu, Jingyun ; Zhao, Xiang ; Yu, Tianxiang ; Qiu, Shanhu ; Zheng, Shiya

Abstract:

Background:

Effective and tolerable treatment for patients with platinum-resistant recurrent ovarian cancer remains a great challenge in clinical practice. This study aimed to evaluate the efficacy and safety of envafolimab, the first subcutaneously administered programmed death ligand 1 (PD-L1) inhibitor, combined with lenvatinib and etoposide in patients with platinum-resistant recurrent ovarian cancer.

Methods:

This was an open-label, single-arm, phase 2 trial (ENLEN-OC-001). Patients with platinum-resistant recurrent ovarian cancer were eligible for inclusion who were administered envafolimab subcutaneously on day 1 and lenvatinib and etoposide orally on days 1-14, with 21 days as a cycle. After 6-10 cycles, envafolimab and lenvatinib were taken as maintenance therapy until intolerable toxicity, disease progression, withdrawal of consent, or finishing 24 months of treatment. The primary endpoint was objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results:

Of the screened 28 patients, 21 were included, with 18 being assessed for the efficacy and safety. The ORR was 44.4% (95% CI 21.5%-69.2%), and the DCR was 83.3% (95% CI 58.6%-96.4%). The median PFS was 10.2 months (95% CI 5.6-not applicable [NA]), and the median OS was 21.3 months (95% CI 6.8-NA). The most common grade 3/4 adverse events were leukopenia (27.8%) and thrombocytopenia (16.7%). No serious adverse events or treatment-related deaths were reported. No changes were observed in the depression, anxiety, and quality of life following treatment.

Conclusion:

Envafolimab combined with lenvatinib and etoposide showed promising efficacy and tolerable safety for patients with platinum-resistant recurrent ovarian cancer.

ClinicalTrials.gov identifier:

NCT05422183

115

News (Medical) associated with Envafolimab

24 Sep 2025

·www.fiercepharma.com

In potential $1.1B deal, Glenmark grabs certain rights to Hengrui's ADC rival to Enhertu

Jiangsu Hengrui Pharmaceuticals is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to Glenmark. Jiangsu Hengrui Pharmaceuticals’ dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu being the latest addition.Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India’s Glenmark Pharmaceuticals, the two parties announced (PDF) Wednesday.The deal is heavily back-loaded, as it features an upfront payment of $18 million and up to $1.09 billion in regulatory and commercial milestones, plus sales-based royalties.The focus is on emerging markets; the partnership excludes the U.S., Canada, Europe, Japan, greater China, Central Asia and a few other countries.“This collaboration with Glenmark is a significant step in Hengrui’s ongoing strategy to deepen its presence in emerging markets,” Jo Feng, president of Hengrui Pharma, said in a Sept. 24 statement (PDF). “We look forward to working together to enhance the accessibility of innovative therapies and to bring new hope to patients in more countries and regions.”For Glenmark, the deal dovetails with the company’s strategy to expand its oncology pipeline, Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, said in a statement. Last year, the Indian pharma bagged rights in certain territories to envafolimab, a subcutaneous PD-L1 inhibitor developed by a trio of Chinese companies. However, that drug has since failed in a pivotal trial in undifferentiated pleomorphic sarcoma or myxofibrosarcoma, forcing its U.S. partner Tracon Pharmaceuticals to close up shop.Hengrui is angling trastuzumab rezetecan as a direct competitor to Enhertu, which generated $3.75 billion in global sales last year and $2.29 billion in the first half of 2025. Both ADCs use trastuzumab as the antibody guide and both utilize an exatecan derivative as the toxic payload. The Hengrui med carries rezetecan, whereas Enhertu leverages deruxtecan.Rezetecan “has high membrane permeability, enabling a bystander killing effect, which further enhances the antitumor efficacy,” Hengrui explained in a securities filing.Trastuzumab rezetecan was approved in China in May 2025 for the treatment of second-line non-small cell lung cancer with HER2-activating mutations, with a breast cancer application also under review by Chinese authorities. The Glenmark licensing deal follows the granting of an orphan drug designation from the FDA for the drug in combination with Hengrui’s PD-L1 inhibitor adebrelimab and chemo in stomach cancer.Besides Enhertu, Hengrui’s HER2 ADC faces another competitor in RemeGen’s China-approved disitamab vedotin, which has been out-licensed to Pfizer. Hengrui has been busy with business development lately. Its recent deals include a potential $12 billion biobucks, up-to-12-asset deal with GSK and a lipoprotein(a) cardiovascular partnership with Merck & Co. that could be worth nearly $2 billion.In addition to HER2, Hengrui’s ADC pipeline covers other popular targets such as TROP2 (targeted by Gilead Sciences’ Trodelvy and AZ and Daiichi’s Datroway), Nectin-4 (targeted by Pfizer and Astellas’ Padcev), Claudin 18.2 (Astellas’ Vyloy), HER3 (Merck and Daiichi’s patritumab deruxtecan) and CD79b (Roche’s Polivy).

License out/inDrug ApprovalOrphan DrugADC

08 Sep 2025

·pharma.economictimes.indiatimes.com

Glenmark advances PD-L1 plans with Envafolimab entry in Phase 3 trials

Mumbai: Advancing its PD-LI plans, Glenmark Pharmaceuticals has announced the initiation of the Phase 3 trial for its lung cancer therapy Envafolimab , across multiple sites including India. The clinical program is designed to assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB Non-Small Cell Lung Cancer (NSCLC) in the adjuvant setting. “By advancing this trial across multiple geographies, we are reinforcing our commitment to transforming the standard of care in Stage III NSCLC and addressing one of the greatest unmet needs in cancer treatment today,” said Dr Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals. Glenmark has also submitted a Clinical Trial Application (CTA) in Russia and is preparing to open additional clinical trial sites in Brazil and Mexico to further expand the global footprint of the multi-nation study. Envafolimab, a novel anti-PD-L1 inhibitor, a key checkpoint protein expressed by various tumours. By blocking its interaction with PD-1 receptors, it enables T-cell activation, leading to an anti-tumor immune response. Invented by Alphamab Oncology, the immunotherapy was co-developed by 3D Medicines Inc and the Indian drugmaker licensed its India, Latin America among several other market development and market rights in 2024. The license agreement outlined a consideration of a “low double-digit million US dollar amount up to launch, along with a “triple-digit million US dollar milestone payments” with a royalty fee of single-to-double-digits percentage according to the level of net sales. In 2021, the Chinese regulator approved Envafolimab brand ‘Enwedia’ for the treatment of advanced unresectable or metastatic solid tumors (MSI-H) and since December 2023 the therapy is further investigated in a Phase 3 study for NSLC sponsored by 3D Medicines Inc in China. PD-LI therapies once part of big pharma portfolio are gaining a strong traction among Indian drugmakers and a standout case is Unloxcyt—an onco-derma drug approved by the FDA for advanced cutaneous squamous cell carcinoma— acquired by Sun Pharma as part of its $355 million deal to buy the therapy owner Checkpoint Therapeutics. By Online Bureau ,

Phase 3License out/inImmunotherapyDrug Approval

23 May 2025

·www.einpresswire.com

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA. Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China. Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system (“CNS”) activity, with reduced CNS progression and fewer new CNS lesions. Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (“IDH”) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate (“ORR”) of 7.1% and a disease control rate (“DCR”) of 100%. Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee (“IRC”)-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy (“NACT/ACT”) showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively. Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET -amplification ( MET amp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China LBA8505 Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Sunday, June 1, 2025 9:48 AM CDT Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 8513 Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic Monday, June 2, 2025 8:06 AM CDT Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX 2013 Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025 3:06 PM CDT Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China 5596 Poster Session: Gynecologic Cancer The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 Jing Wang, Hunan Cancer Hospital, Changsha, China 5611 Poster Session: Gynecologic Cancer Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study Yi Wang, Ningbo No.2 Hospital, Ningbo, China e15512 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China e15515 Publication Only: Gastrointestinal Cancer - Colorectal and Anal The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China e16011 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China e16012 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary INVESTIGATOR-INITIATED STUDIES Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 4042 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China 4046 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China TPS4203 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China e15530 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Ling Xu, the First Hospital of China Medical University, Shenyang, China e15539 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China e15541 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China e15550 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial Fei Ma, Henan Cancer Hospital, Zhengzhou, China e16016 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China e23506 Publication Only: Sarcoma Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 4028 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China 4157 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China 4161 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China 5589 Poster Session: Gynecologic Cancer The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China e16209 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China e16222 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results from a multicenter, single-arm Phase II study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China e16342 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China e16442 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing 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 approved around the world including in the US, Europe and Japan. 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 US 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 savolitinib, ranosidenib, fruquintinib and surufatinib, the further clinical development for savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to whether any studies on savolitinib, ranosidenib, fruquintinib and surufatinib 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 savolitinib, ranosidenib, fruquintinib and surufatinib, 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 savolitinib, ranosidenib, fruquintinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products 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 US 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 FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultPhase 2ASCOPhase 3Phase 1

100 Deals associated with Envafolimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Colorectal Cancer	China	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021
Microsatellite Instability-high Solid Tumors	China	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	27 Nov 2023
Non-small cell lung cancer stage IIIB	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	17 Nov 2023
Locally Advanced Rectal Carcinoma	Phase 3	China	Sir Run Run Shaw Hospital	01 Apr 2023
Bile Duct Neoplasms	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Bile Duct Neoplasms	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic Biliary Tract Carcinoma	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Metastatic Biliary Tract Carcinoma	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic gallbladder cancer	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic gallbladder cancer	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Advanced biliary tract cancer	Phase 3	-	3D Medicines (Shanghai) Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05298020 (ESMO2025) Manual	Phase 2	Metastatic Pancreatic Cancer	12	Envafolimab+RhRh-endostatinemcgemcitabine-panab-paclitaxel	engshfszwz(eobpbxxjmm) = vrgsuawika wpyycwkpre (nrmkyqrfye ) View more	Positive	17 Oct 2025
ESMO2025 Manual	Phase 2	Locally Advanced Rectal Carcinoma Neoadjuvant Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	41	Envafolimab + CapeOX	gditmiqbis(yhvaqzxyxl) = zryoucyowy pufsjalypl (gjgldmdsya, 42.6 - 81.3) View more	Positive	17 Oct 2025
NCT06698965 (ESMO2025)	Phase 2	Small Cell Lung Cancer	19	Trilaciclib + Etoposide + Carboplatin + Envafolimab	ibqfpeodcf(ajyndvkfwg) = nitzxoevlq ohdpfojnqt (cpudyoywnx ) View more	Positive	17 Oct 2025
NCT06698965 (ESMO2025)	Phase 2	Small Cell Lung Cancer	19	Etoposide + Carboplatin + Envafolimab	ibqfpeodcf(ajyndvkfwg) = mcdusmqzny ohdpfojnqt (cpudyoywnx ) View more	Positive	17 Oct 2025
NCT05799469 (ESMO2025)	Phase 2	Locally Advanced Cervical Carcinoma	36	Envafolimab 150 mg QW + concurrent chemoradiotherapy (CCRT) (locally advanced cervical cancer (FIGO 2018 stage IB3/IIA2/IIB/III-IVA))	prdqkjyydy(nvfqfcgngm) = rvrlummciw ojgicrgvps (ydhehnrlmx ) View more	Positive	17 Oct 2025
NCT05397769 (ESMO2025)	Phase 2	Advanced Nasopharyngeal Carcinoma	36	Envafolimab + Gemcitabine + Cisplatin + DDP	mzxugtulfb(ozdbearsgz) = hhhejrotqw kxunfoetcp (xhfpmxvnid, 0.92 - 1) View more	Positive	17 Oct 2025
NCT05422183 (ENLEN-OC-001, Pubmed \| Oncologist)	Phase 2	Platinum-Resistant Ovarian Carcinoma	18	Envafolimab + Lenvatinib + Etoposide	temlvzyfbl(jjevejkpjh) = hpatcyfipu tnyjlbcyoi (nunjvulivy, 21.5 - 69.2) View more	Positive	01 Sep 2025
NCT04891198 (ASCO2025) Manual	Phase 2	Advanced Malignant Solid Neoplasm TMB-High	70	Envafolimab (tTMB≥13 mut/Mb)	rzpmmsmrgg(roqfswlext) = slubpxqgvi rdhwvcvgye (ugvhecwtos, 15.6 - 55.3) View more	Positive	30 May 2025
NCT04891198 (ASCO2025) Manual	Phase 2	Advanced Malignant Solid Neoplasm TMB-High	70	Envafolimab (tTMB<13 mut/Mb)	rzpmmsmrgg(roqfswlext) = haeclamuwj rdhwvcvgye (ugvhecwtos, 0.5 - 14.8) View more	Positive	30 May 2025
NCT05910034 (ASCO2025)	Phase 2	Non-Small Cell Lung Cancer Second line PD-1 inhibitors	25	Trilaciclib+Envafolimab+Docetaxel	fgwemfshjl(dbnzmwjecz) = Hematological toxicity occurred in 17/25 (68%) pts during the first cycle, with a lower incidence in cohort A compared to cohorts B and C rvokuyfhsd (yhvzxjkjof ) View more	Positive	30 May 2025
NCT05910034 (ASCO2025)	Phase 2	Non-Small Cell Lung Cancer Second line PD-1 inhibitors	25	Docetaxel+Envafolimab		Positive	30 May 2025
NCT05243355 (ASCO2025)	Phase 2	Squamous non-small cell lung cancer First line	33	Envafolimab + Rh-endostatin + Paclitaxel + Cisplatin	mfpitnugfg(mdnmxmvjwp) = czwipfwgyc vpmjhzswrn (dcmrcvxszw, 43.0% - 83.3%) View more	Positive	30 May 2025
NCT05828381 (Phase II study, ASCO2025)	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	32	Envafolimab + Albumin-bound Paclitaxel + Cisplatin	owgcqsynrh(eowyijmgpb) = One patient occurred cerebral hemorrhage orymafgxoa (tccgliehjq ) View more	Positive	30 May 2025

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