VEGFR1 antagonists(Vascular endothelial growth factor receptor 1 antagonists), VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists), VEGFR3 antagonists(Vascular endothelial growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersUrogenital Diseases

Active Indication

Locally Advanced Renal Cell CarcinomaMetastatic Renal Cell CarcinomaMSS/pMMR/MSI-L Endometrial Carcinoma+ [19]

Inactive Indication

Adenocarcinoma of large intestineAdvanced Colorectal AdenocarcinomaAdvanced gastric carcinoma+ [13]

Originator Organization

Hutchison MediPharma Ltd.

Active Organization

Takeda Pharmaceuticals International AG

BeOne Medicines Ltd.

Hutchison MediPharma Ltd.

+ [10]

Inactive Organization

Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.

License Organization

Eli Lilly & Co.

Takeda Pharmaceutical Co., Ltd.

BeOne Medicines Ltd.

+ [3]

Drug Highest PhaseApproved

First Approval Date

China (04 Sep 2018),

Metastatic Colorectal Carcinoma

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

Structure/Sequence

Molecular FormulaC21H19N3O5

InChIKeyBALLNEJQLSTPIO-UHFFFAOYSA-N

CAS Registry1194506-26-7

256

Clinical Trials associated with Fruquintinib

NCT07689292

/ Not yet recruitingPhase 2IIT

Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With Fruquintinib as Second-Line Therapy for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

This is a phase 2 multicenter study that will evaluate the safety and efficacy of sacituzumab tirumotecan (Sac-TMT) plus fruquintinib for the treatment of participants with locally advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma who have failed 1 prior line of therapy.

Start Date31 Jul 2026

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

[+1]

NCT07621159

/ Not yet recruitingPhase 1/2

A Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy and Safety of HDM2017 in Combination With Standard of Care in Participants With Advanced Colorectal Cancer

This is a phase Ib/II clinical study. All participants are patients with advanced colorectal cancer (CRC). The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy of HDM2017 in combination with standard of care in patients with advanced CRC.

Start Date15 Jul 2026

Sponsor / Collaborator

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

NCT07658872

/ Not yet recruitingPhase 2IIT

Perioperative Fruquintinib Combined With Sintilimab and SOX Versus Sintilimab and SOX for Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Multicenter,Open-label, Randomized Controlled Phase II Clinical Study

The purpose of this clinical trial is to evaluate whether perioperative fruquintinib combined with sintilimab and SOX is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.
Primary Objective:
To determine whether perioperative fruquintinib combined with sintilimab and SOX improves the pathological complete response (pCR) rate compared with sintilimab plus SOX in patients with locally advanced gastric or GEJ adenocarcinoma.
Study Design:
Participants will be randomly assigned to receive either fruquintinib combined with sintilimab and SOX or sintilimab plus SOX to evaluate the potential added benefit of fruquintinib in this setting.
Participation Details:
Participants will receive the assigned treatment (fruquintinib combined with sintilimab and SOX or sintilimab plus SOX) every 21 days for approximately 3 months.
They will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.
Participants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.

Start Date15 Jun 2026

Sponsor / Collaborator

Sichuan University

100 Clinical Results associated with Fruquintinib

100 Translational Medicine associated with Fruquintinib

100 Patents (Medical) associated with Fruquintinib

272

Literatures (Medical) associated with Fruquintinib

01 Jul 2026·CLINICAL ONCOLOGY

A Real-World Study: Effect of the Third-Line Therapy of Fruquintinib or Regorafenib Therapy Versus Rechallenge Chemotherapy in Metastatic Colorectal Cancer

Article

Author: Du, J ; Zhang, X ; Xu, X ; Chen, L ; Li, C ; Tang, W ; Zhou, S ; Wang, Q ; Liu, Y ; Guo, Q ; Zhen, H ; Xu, H ; Cai, C ; Wu, J ; Fu, J ; Jin, X

AIM:

Third-line treatment options for metastatic colorectal cancer (mCRC) remain limited. Chemotherapy rechallenge has shown efficacy in this setting, but direct comparisons with tyrosine kinase inhibitors (TKIs) are lacking. This real-world study aimed to retrospectively compare TKI (regorafenib/fruquintinib) versus rechallenge chemotherapy in refractory mCRC.

MATERIALS AND METHODS:

From April 2018 to June 2023, 107 mCRC patients receiving third-line therapy were analyzed (median follow-up: 6.6 months). Endpoints included overall survival (OS) and progression-free survival (PFS). Patients were divided into TKI (n = 53) and rechallenge chemotherapy (n = 54) groups. Kaplan-Meier curves, Cox models, and RECIST 1.1-based spider/waterfall plots were generated using RStudio (R Foundation for Statistical Computing, Vienna, Austria) 3.5.2 (significance: P < .05).

RESULTS:

Rechallenge chemotherapy significantly improved OS (hazard ratio [HR] = 0.44, 95% CI = 0.27-0.70; P < .001) and PFS (HR = 0.58, 95% CI = 0.27-0.70; P = .002) with significantly higher objective response rate (10.9% vs. 0%, P = .025) and disease control rate (67.4% vs. 52.8%, P = .090) compared to TKIs.

CONCLUSION:

In this single-center retrospective real-world cohort, rechallenge chemotherapy was associated with improved survival and response outcomes compared with TKIs in third-line mCRC. However, given the non-randomized design and potential confounding, these findings should be considered hypothesis-generating. Rechallenge chemotherapy may be considered in selected patients with prior chemotherapy sensitivity and an adequate treatment-free interval, pending prospective validation.

06 Jun 2026·ONCOLOGIST

Survival benefit of oral systemic monotherapy in previously treated metastatic colorectal cancer: a meta-analysis

Article

Author: Hernandez, Luis ; Pfeiffer, Per ; Elez, Elena ; Cremolini, Chiara ; Ducreux, Michel ; Osterlund, Pia ; Ronnebaum, Sarah ; Paly, Victoria ; Akin-Fajiye, Morodoluwa

Abstract:

Background:

Guideline-recommended nontargeted systemic therapies for previously treated metastatic colorectal cancer (mCRC) include regorafenib, trifluridine/tipiracil, and fruquintinib, but no consensus exists on the definition of clinically meaningful improvements for later-line mCRC treatments.

Materials and methods:

Trials were identified from systematic searches in MEDLINE, Embase, and the Cochrane Library. Meta-analyses were performed to characterize overall survival (OS) and progression-free survival (PFS) improvements with systemic therapy vs placebo in previously treated mCRC. Meta-analyses were conducted using fixed-effect and random-effects (RE) frequentist models of difference in medians, hazard ratios (HRs), and 12-month restricted mean survival time (RMST).

Results:

Six randomized, placebo-controlled, phase III trials of 3277 patients comparing oral systemic monotherapies with placebo were analyzed. Using the RE model, the meta-analyzed OS estimate for oral systemic monotherapy vs placebo was 1.86 months (95% confidence interval [CI], 1.30-2.42) for the difference in medians, 0.69 (95% CI, 0.64-0.76) for HRs, and 1.25 months (95% CI, 0.69-1.82) for the difference in 12-month RMST. For PFS, meta-analyzed median improvement was 0.97 months (95% CI, 0.28-1.66), HR was 0.38 (95% CI, 0.30-0.47), and 12-month RMST difference was 1.90 months (95% CI, 1.41-2.39). Sensitivity analyses, excluding the FRESCO-2 trial due to prior treatment differences, confirmed the primary meta-analysis results.

Conclusion:

When assessing the clinical benefit of later-line mCRC treatments, the broad clinical picture, including individualized treatment goals, should be evaluated. Considering multiple survival measures in the later-line mCRC context, an incremental survival improvement with oral systemic monotherapy vs no active therapy is clinically meaningful.

01 Jun 2026·British Journal of Pharmacology

Hand–foot skin reaction as a positive prognostic factor in vascular endothelial growth factor receptor‐tyrosine kinase inhibitor treatment

Review

Author: Wu, Po‐Chien ; Yeh, Chun‐Nan ; Huang, I‐Hsin ; Chi, Ching‐Chi

Abstract:

Hand–foot skin reaction (HFSR) is a common adverse effect of vascular endothelial growth factor receptor‐tyrosine kinase inhibitors (VEGFR‐TKIs), but its prognostic value remained disputable. In this study, we aimed to assess the association between HFSR and survival outcomes in cancer patients receiving VEGFR‐TKIs. MEDLINE, Embase and the Cochrane Central Register of Controlled Trials were searched from inception to 29 June 2025. Two authors independently selected cohort studies, extracted data and appraised the risk of bias of included studies using the Quality In Prognosis Studies checklist. The outcomes were overall survival (OS) and progression‐free survival (PFS). A random‐effects model meta‐analysis was performed to calculate pooled hazard ratio (HR) with 95% confidence intervals (CIs). Subgroup analyses based on various cancer types and VEGFR‐TKIs types were also conducted. Thirty‐two observational studies involving 6543 patients receiving VEGFR‐TKIs were included, of whom 2671 experienced HFSR. Patients who developed VEGFR‐TKI‐induced HFSR showed better OS (HR 0.54, 95% CI 0.49–0.60) and PFS (HR 0.59, 95% CI 0.53–0.65) compared with those who did not. Subgroup analysis revealed significantly improved OS and PFS in patients with hepatocellular carcinoma, colorectal cancer or non‐small cell lung cancer who developed VEGFR‐TKI‐induced HFSR. HFSR was also a positive prognostic factor for OS and PFS in patients receiving sorafenib, regorafenib, fruquintinib, anlotinib and cabozantinib. In conclusion, VEGFR‐TKI‐induced HFSR may serve as a positive surrogate marker for survival. Early detection and optimal management for HFSR in patients receiving VEGFR‐TKI therapy is needed to maintain treatment efficacy and life quality.

Systematic Review Protocol Registration:

PROSPERO CRD42024598845.

192

News (Medical) associated with Fruquintinib

06 Jul 2026

·www.businesswire.com

Agenus Reports Landmark BOT+BAL Data Showing 33% Three-Year Overall Survival in Refractory MSS Metastatic Colorectal Cancer Without Active Liver Metastases at ESMO GI 2026

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced three-year landmark Phase 1b data from the fully enrolled C-800-01 cohort evaluating botensilimab (BOT), an Fc-enhanced multifunctional anti–CTLA-4 antibody, plus balstilimab (BAL), an anti–PD-1 antibody, in patients with refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. The data were presented at the European Society for Medical Oncology Gastrointestinal Cancers (ESMO GI) Congress 2026 on July 2 in Munich, Germany. With longer follow-up, we are seeing the elements that matter for a potentially differentiated immunotherapy regimen: durable survival, sustained responses, treatment-free intervals, and a manageable safety profile. BOT+BAL demonstrated clinically meaningful long-term survival in a heavily pretreated patient population with historically limited benefit from conventional immune checkpoint inhibitors and few durable treatment options after progression on standard therapies. With extended follow-up, median overall survival was 21.2 months and the three-year overall survival rate was 33%, with the Kaplan-Meier curve showing a plateau beyond two years. Available later-line standards in refractory MSS mCRC without active liver metastases have historically reported median overall survival of approximately 10–14 months in relevant analyses, reflecting a treatment setting in which few patients have historically remained alive at later landmark timepoints and pivotal studies have generally focused on median survival rather than mature 36-month overall survival outcomes.i In this context, the survival profile, curve plateau beyond two years, and proportion of patients alive and off systemic anticancer therapy support the durability of benefit observed with BOT+BAL in this fully enrolled 123-patient Phase 1b cohort. The data build on the two-year overall survival results presented by Dr. Benjamin L. Schlechter of Dana-Farber Cancer Institute at ESMO GI 2025 and reflect an additional year of follow-up from the same cohort. With longer follow-up, the dataset now includes 26 confirmed responses; median duration of response was not reached; and 21 patients, or 17%, were alive and off all systemic anticancer therapy at last follow-up, including 13 responders. “These three-year data are important because they show a pattern of benefit that is not typically expected in refractory MSS colorectal cancer,” said Benjamin L. Schlechter, M.D., of Dana-Farber Cancer Institute and presenting author of the study. “These are patients who had received multiple prior lines of therapy and had few remaining options. Seeing a subset of patients remain alive and off systemic anticancer therapy after treatment speaks to the clinical relevance of these results and the potential for botensilimab plus balstilimab to change expectations for what immunotherapy may achieve in this setting.” “BOT+BAL is not simply another checkpoint combination; it was designed to activate antitumor immunity in tumors that have been difficult to reach with conventional immunotherapy,” said Steven O’Day, M.D., Chief Medical Officer of Agenus. “With longer follow-up, we are seeing the elements that matter for a potentially differentiated immunotherapy regimen: durable survival, sustained responses, treatment-free intervals, and a manageable safety profile. These findings strengthen the foundation for BATTMAN and our broader development strategy in MSS colorectal cancer.” The Phase 1b (NCT03860272) cohort included 123 patients with MSS mCRC without active liver metastases. Patients had received a median of three prior lines of therapy; 67% had received at least three prior lines, 15% had received prior anti–PD-(L)1 with or without anti–CTLA-4 therapy, and 30% had received at least one later-line regimen of regorafenib, trifluridine/tipiracil with or without bevacizumab, or fruquintinib. Key Efficacy Results: Median overall survival: 21.2 months, with 24-month and 36-month overall survival rates of 41% and 33%, respectively Confirmed objective response rate : 21%, including three complete responses and 23 partial responses Median duration of response: not reached; responses ranged from 1.9 months to at least 37.4 months Disease control rate : 69% at six weeks Clinical benefit rate : 28% at 24 weeks Tumor regression : observed in more than 40% of patients Treatment-free survival: 21 patients or 17%, were alive and off all systemic anticancer therapy, including 13 responders with a subset of patients remaining free from subsequent therapy or death for more than two years In a post hoc late-line–exposed subgroup of 37 patients who had received at least one prior regimen of regorafenib, trifluridine/tipiracil with or without bevacizumab, or fruquintinib, BOT+BAL showed a confirmed objective response rate of 22%, median overall survival of 16.2 months, and a three-year overall survival rate of 30%. In this subgroup, median duration of response was 16.6 months, disease control rate was 70%, and clinical benefit rate at 24 weeks was 27%. Safety Results With extended follow-up, no new safety signals were observed and there were no treatment-related deaths. Immune-mediated diarrhea/colitis resolved in 98% of affected patients, with a median time to resolution of 14 days from onset. Treatment-related immune-mediated diarrhea/colitis was the most common immune-mediated adverse event (42%; grade ≥3, 15%). The selected Phase 3 regimen of BOT 1 mg/kg plus BAL demonstrated improved tolerability, with lower rates of immune-mediated diarrhea/colitis (27%; grade ≥3, 10%) than the 2 mg/kg regimen. Together, the mature efficacy, treatment-free survival, and extended safety findings support continued evaluation of BOT+BAL in MSS mCRC and provide rationale for the ongoing randomized Phase 3 BATTMAN trial evaluating BOT+BAL in refractory MSS/proficient mismatch repair (pMMR) metastatic colorectal cancer. Presentation Details Abstract Title: Botensilimab + Balstilimab in Microsatellite-Stable Metastatic Colorectal Cancer Without Active Liver Metastases: Extended Follow-Up and 3-Year Survival Presenter: Benjamin L. Schlechter, M.D.; Dana-Farber Cancer Institute, Boston, MA, USA Final Publication Number: 91P Congress: European Society for Medical Oncology Gastrointestinal Cancers Congress 2026 Location: ESMO GI, 2026 | Munich, Germany Poster Availability: The poster is available on the Agenus publications page. About the C-800-01 Study (NCT03860272) C-800-01 is a first-in-human Phase 1b clinical trial evaluating botensilimab with or without balstilimab in patients with advanced solid tumors. The MSS mCRC without active liver metastases cohort enrolled 123 patients who received BOT 1 mg/kg or 2 mg/kg every six weeks plus BAL 3 mg/kg every two weeks. The primary endpoint was safety and tolerability. Secondary endpoints included objective response rate, duration of response, disease control rate, and progression-free survival. Exploratory endpoints included overall survival and clinical benefit rate. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Clinical ResultImmunotherapyPhase 1Phase 2Phase 3

27 May 2026

·www.biospace.com

ViroMissile IDOV-Safe Phase 1 Data to Be Presented at the 2026 ASCO Annual Meeting

IDOV-Safe demonstrates efficient intravenous delivery, manageable safety, and encouraging anti-tumor activity in heavily pretreated patients with pMMR/MSS metastatic colorectal cancer, supporting further evaluation in a Phase 2 study SAN DIEGO, May 27, 2026 (GLOBE NEWSWIRE) -- ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV™ (Intravenously Deliverable Oncolytic Virus) platform, today announced the presentation of clinical data from an investigator-initiated Phase I study of IDOV-Safe, the company’s first clinical-stage oncolytic virus, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The poster, titled "Intravenous oncolytic virus IDOV-Safe in pMMR/MSS metastatic colorectal cancer” (Abstract #3536), will be presented on Saturday, May 30 th , at Poster Board 290 by Tong Xie, MD, of Peking University Cancer Hospital & Institute in Beijing, China. The study’s principal investigator is Lin Shen, MD, of the same institution. "These findings validate a core hypothesis underlying our IDOV platform that systemic delivery of an oncolytic virus can prime immune responses even in tumors historically considered immune-cold,” said Nanhai George Chen, PhD, Founder and Chief Executive Officer of ViroMissile. “Achieving a 30-46% response rate in pMMR/MSS metastatic colorectal cancer, a setting where checkpoint inhibitors have largely fallen short, represents an encouraging signal that warrants further investigation. We look forward to advancing this approach into our contemplated registrational Phase 2 study.” The data are from a study evaluating IDOV-Safe in combination with fruquintinib, a VEGF inhibitor, and toripalimab, a PD-1 inhibitor, in patients (n=55) with proficient mismatch repair/microsatellite stable (pMMR/MSS) metastatic colorectal cancer (mCRC). Patients with mCRC historically have limited treatment options and poor response to checkpoint inhibitor-based immunotherapy. The poster highlights results from a key expansion cohort (n=20) where treatment with IDOV-Safe demonstrated an objective response rate (ORR) of 30.0% and a disease control rate (DCR) of 70.0%, with a median progression-free survival (PFS) of 8.7 months. In patients without liver metastases, ORR reached 46.2% and median PFS extended to 10.8 months. Study Design The investigator-initiated Phase I trial treated a total 55 patients with pMMR/MSS mCRC across all cohorts. The study employed a triplet 3+3 dose-escalation design to assess dose-limiting toxicities (DLTs) and determine the maximum tolerated dose and the recommended expansion dose. Expansion cohorts assessed IDOV-Safe in combination with fruquintinib and with or without toripalimab across three combination strategies: sequential, early, and IO-free. Primary and secondary endpoints included safety, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS). Key findings Safety IDOV-Safe demonstrated a manageable safety pro all dose levels 62% of patients experienced Grade 3 or higher treatment-related adverse events (TRAEs), with only one Grade 4 TRAE reported as a dose-limiting toxicity (DLT). The most common TRAEs were transient fever, thrombocytopenia, and neutropenia No treatment-related deaths were observed Efficacy/Tumor Response In the sequential combination expansion cohort, which received IDOV-Safe at the higher dose level in combination with fruquintinib and toripalimab, the results demonstrated: An objective response rate (ORR) of 30.0% was observed overall in the key expansion cohort In patients without liver metastases, ORR reached 46.2% with a DCR of 84.7% and a median PFS of 10.8 months, compared to a median PFS of 3.7 months in patients with liver metastases Median progression-free survival (PFS) was 8.7 months overall. The poster will be available on the ViroMissile website after the conclusion of the session. About ViroMissile, Inc. ViroMissile, Inc. is a cancer immunotherapy company harnessing a systemically delivered oncolytic virus that seeks and selectively destroys tumors throughout the body. As the first company to demonstrate effective and efficient intravenous tumor targeting with an oncolytic virus in humans, ViroMissile is leading a new era of viral immunotherapy that combines direct tumor killing with immune activation for durable responses in patients with advanced solid tumors. The company's proprietary IDOV™ (Intravenously Deliverable Oncolytic Virus) platform is designed to extend the reach of immunotherapy to metastatic and treatment-resistant cancers. Media Contact: Maggie Whitney mwhitney@lifescicomms.com 203-957-1502

Clinical ResultImmunotherapyASCOPhase 1Phase 2

22 May 2026

·www.biospace.com

HUTCHMED Highlights Clinical Data to be Presented at the 2026 ASCO Annual Meeting

HONG KONG and FLORHAM PARK, N.J., May 22, 2026 (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 American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place from May 29 to June 2, 2026 in Chicago, USA. Results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China will be presented during a rapid oral session. The study met its primary endpoint of objective response rate (“ORR”) per RECIST 1.1, as assessed by the Independent Review Committee (“IRC”). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%, median time to response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 (95%CI: 3.7, 18.5) months, and median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months, respectively. The data supported the New Drug Application (NDA) submission to the China National Medical Products Administration (NMPA), which was accepted and granted priority review in December 2025. Additionally, further analyses of the fruquintinib’s FRESCO, FRESCO-2, FRUSICA-1 and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib spanning across a diverse range of potential tumor indications will be presented. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead Author Presentation details SPONSORED STUDIES A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas Zhi Peng, Beijing, China 4011 Rapid Oral Abstract Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Monday, June 1, 2026 1:15 PM CDT Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2 Elena Elez, Barcelona, Spain 3555 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study Kaiwei Yang, Beijing, China 4531 Poster Session: Genitourinary Cancer – Kidney and Bladder Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden Yuanyuan Qu, Shanghai, China 4533 Poster Session: Genitourinary Cancer – Kidney and Bladder Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1 Xiaotian Han, Shanghai, China e17612 Publication Only: Gynecologic Cancer INVESTIGATOR-INITIATED STUDIES Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial Jianmin Xu, Shanghai, China LBA3563 Poster Session: Gastrointestinal Cancer – Colorectal and Anal CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Yue Liu, Hangzhou, China TPS3680 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF-080/QUINTIS trial Joseph Tintelnot, Hamburg, Germany TPS3684 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety Chang Wang, Changchun, China 2631 Poster Session: Developmental Therapeutics – Immunotherapy Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study Yun Xu, Shanghai, China 3528 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC) Wenhua Li, Shanghai, China 3534 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases Mengzhou Guo, Shanghai, China 3552 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study Xiaodong Zhu, Shanghai, China 4063 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) Hao Wen, Shanghai, China 5579 Poster Session: Gynecologic Cancer Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study Wangjun Liao, Guangzhou, China e15539 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study Yifu He/Jiayu Niu, Hefei, China e15560 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer Qian Li, Nanning, China e15571 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial Wei Li, Suzhou, China e15583 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States Vasu Bansal, Kansas City, US e15713 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION) Beibei Chen, Zhengzhou, China e16033 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study Yanhong Gu, Nanjing, China e16070 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Xuetao Shi/Jingtao Zhong, Jinan, China 4136 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial Wenquan Wang, Shanghai, China 4198 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single-arm phase II clinical trial Huijuan Yang, Shanghai, China 5586 Poster Session: Gynecologic Cancer Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study Bei Xu, Shanghai, China 8119 Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study Fuxiang Zhou, Wuhan, China e16172 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study Shasha Fan, Changsha, China e16222 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study Xiang Han, Qingdao, China e20079 Publication Only: Lung Cancer – Non-Small Cell Local-Regional/ Small Cell/Other Thoracic Cancers 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: 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 fruquintinib, savolitinib and surufatinib, the further clinical development for fruquintinib, savolitinib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib 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 fruquintinib, savolitinib 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 fruquintinib, savolitinib 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 / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Duncan Monteith / Ramin Naji +44 20 7545 8000

Clinical ResultPhase 2ASCOPhase 1Immunotherapy

100 Deals associated with Fruquintinib

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KEGG	Wiki	ATC	Drug Bank
D11977	-	L01XE	DB11679

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Locally Advanced Renal Cell Carcinoma	China	Hutchison MediPharma Ltd.	19 May 2026
Metastatic Renal Cell Carcinoma	China	Hutchison MediPharma Ltd.	19 May 2026
MSS/pMMR/MSI-L Endometrial Carcinoma	China	Hutchison MediPharma Ltd.	01 Dec 2024
Colorectal Cancer	Japan	Takeda Pharmaceutical Co., Ltd.	24 Sep 2024
Metastatic Colorectal Carcinoma	China	Hutchison MediPharma Ltd.	04 Sep 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	NDA/BLA	China	Hutchison MediPharma Ltd.	29 Mar 2024
Gastroesophageal junction adenocarcinoma	NDA/BLA	China	Hutchison MediPharma Ltd.	18 Apr 2023
Stomach Cancer	NDA/BLA	China	Hutchison MediPharma Ltd.	18 Apr 2023
Metastatic gastric adenocarcinoma	Phase 3	France	Takeda Development Center Americas, Inc.	15 Dec 2025
Metastatic gastric adenocarcinoma	Phase 3	Germany	Takeda Development Center Americas, Inc.	15 Dec 2025
Metastatic gastroesophageal adenocarcinoma	Phase 3	France	Takeda Development Center Americas, Inc.	15 Dec 2025
Metastatic gastroesophageal adenocarcinoma	Phase 3	Germany	Takeda Development Center Americas, Inc.	15 Dec 2025
Advanced Renal Cell Carcinoma	Phase 3	China	Hutchison MediPharma Ltd.	14 Oct 2022
Renal Cell Carcinoma	Phase 3	China	Hutchison MediPharma Ltd.	14 Oct 2022
Metastatic colon cancer	Phase 3	United States	Hutchison MediPharma Ltd.	12 Aug 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02314819 (FRESCO, ASCO2026)	Phase 3	Metastatic Colorectal Carcinoma	839	Fruquintinib + BSC (pts with TS)	ifhnbmrbkk(aqdgtfhsry) = ayybupfwmd oxhuaiiubc (irrdmvoimn ) View more	Positive	29 May 2026
				Fruquintinib + BSC (pts with ETS)	ifhnbmrbkk(aqdgtfhsry) = cfckuwhkqr oxhuaiiubc (irrdmvoimn ) View more
NCT06158919 (MGC-FLORA, ASCO2026)	Phase 2	Advanced Gastric Adenocarcinoma First line	126	chemo+immuno	rzhnonembo(csyomvgzun) = tvwaaxlujt xpassfrugr (mmudatpqaz ) View more	Positive	29 May 2026
				chemo+immuno+fruquintinib	rzhnonembo(csyomvgzun) = trmlzuykap xpassfrugr (mmudatpqaz ) View more
ChiCTR2400079429 (ASCO2026)	Phase 2	Secondary malignant neoplasm of lung Third line MSS/pMMR	37	Fruquintinib + Fruquintinib (MSS/pMMR colorectal cancer + pulmonary metastases)	wfigpxeexd(javjltmgyj) = axroawoefa uyvquzznnj (ghfifwqkfu ) View more	Positive	29 May 2026
NCT05451719 (ASCO2026)	Phase 2	Metastatic Colorectal Carcinoma Maintenance	107	Fruquintinib plus Capecitabine	zxahrszdla(npxatgwfqc) = xwsubenqax pobtqdsonc (icozzpwufg ) View more	Positive	29 May 2026
				Capecitabine	zxahrszdla(npxatgwfqc) = iunrqitjra pobtqdsonc (icozzpwufg ) View more
NCT05555901 (ASCO2026)	Phase 3	Metastatic Colorectal Carcinoma Second line	122	Fruquintinib + FOLFIRI	coyywfuhgw(jimplibfgp) = ptycuuhdfj dmyhpsodyc (povxuzronh, 7.85 - 11.68) View more	Non-inferior	29 May 2026
				Bevacizumab + FOLFIRI	coyywfuhgw(jimplibfgp) = augzubdawd dmyhpsodyc (povxuzronh, 6.67 - 10.03) View more
NCT06329973 (FUNCTION, ASCO2026)	Phase 1/2	Advanced Gastric Adenocarcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma First line	24	Sintilimab 200mgFruquintinib (various doses) + Sintilimab 200mgFruquintinib (various doses) + Sintilimab 200mgFruquintinib (various doses)	fzwpanxlba(rzotnsgxyy) = wxomjkkugd fbuqelqvtf (yojykmnxef ) View more	Positive	29 May 2026
NCT06010212 (ASCO2026)	Phase 2	Advanced Esophageal Squamous Cell Carcinoma First line	34	Fruquintinib + Camrelizumab + Paclitaxel liposome + Nedaplatin	zwmjgjglsh(zbhhmyxmfz) = tusrjnqhxr eyexsybeix (acngvbsozf, 48.6 - 80.8) View more	Positive	29 May 2026
NCT06979908 (ASCO2026)	Phase 2	Colorectal Cancer Microsatellite stable (MSS)	9	Fruquintinib+sintilimab+chidamide (Microsatellite stable metastatic colorectal cancer)	flxstcrbsi(nrxfeflwdk) = exkrmhvfwl bihaiweyua (rfqrfvlzuz ) View more	Positive	29 May 2026
NCT06973421 (FRUTD, ASCO2026)	Phase 2	Recurrent Platinum-Resistant Ovarian Carcinoma	14	Utidelone plus Fruquintinib	jmjzwsqmgg(kcjyxpodhf) = tdkytadizr jrgpfprkvz (smvjfgqkzo, 38.8 - 83.7) View more	Positive	29 May 2026
IKF-080 (ASCO2026)	Phase 2	MSS/pMMR/MSI-L Colorectal Carcinoma microsatellite-stable	140	Fruquintinib 5 mgTislelizumab 400 mg + Fruquintinib 5 mgTislelizumab 400 mg (Metastatic colorectal adenocarcinoma + No active liver metastases)	ninyrpojja(aovllgmgnb) = kwpoeerkqp hufuscxbqo (vknguhqbcv, 16 - 33)	Positive	29 May 2026
				Bevacizumab 5 mg/kgcil 35 mg/m² + Bevacizumab 5 mg/kg (Metastatic colorectal adenocarcinoma + No active liver metastases)	ninyrpojja(aovllgmgnb) = mycxjjqoys hufuscxbqo (vknguhqbcv, 3 - 10) View more

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