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Last update 29 May 2025

Regorafenib

Last update 29 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DAST, fluoro-sorafenib, Regorafenib Hydrate

+ [9]

Target

ABL x BRAF x BRAF V600E x CRAF x CSF-1R x DDR2 x EphA2 x FGFR1 x FGFR2 x FRK x MAPK11 x PDGFRα x PDGFRβ x RET x Tie-2 x TrkA x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit

Action

inhibitors, antagonists

Mechanism

ABL inhibitors(Abl family tyrosine kinases inhibitors), BRAF V600E inhibitors, BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [8]

Active Indication

Liver CancerHepatocellular CarcinomaColorectal Cancer+ [55]

Inactive Indication

Acute Myeloid LeukemiaAdenocarcinoma of large intestineAdvanced biliary tract cancer+ [31]

Originator Organization

Bayer AG

Active Organization

Merck KGaA

Bayer AG

Bristol Myers Squibb Co.

+ [7]

Inactive Organization

Bayer Healthcare Co., Ltd.Bayer Schering Pharma AG

Xencor, Inc.

+ [1]

License Organization

Amgen, Inc.

Bayer Healthcare Co., Ltd.

Onyx Pharmaceuticals, Inc.

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (27 Sep 2012),

Metastatic Colorectal Carcinoma

RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC21H17ClF4N4O4

InChIKeyZOPOQLDXFHBOIH-UHFFFAOYSA-N

CAS Registry1019206-88-2

363

Clinical Trials associated with Regorafenib

NCT06820957

/ Not yet recruitingPhase 2/3IIT

Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma

This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Ifosfamide, a type of alkylating agent and a type of antimetabolite, attaches to DNA in cells and may kill tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving VIrR/VDC/IE may be more effective than usual treatment with VDC/IE in treating patients with newly diagnosed metastatic Ewing sarcoma or other round cell sarcomas.

Start Date15 Jul 2025

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT06902246

/ Not yet recruitingPhase 2IIT

Regorafenib and Yttrium-90 Radioembolization for Treatment of Unresectable Hepatocellular Carcinoma

The purpose of this study is to determine the effects that Regorafenib in combination with Yttrium-90 (Y-90) radioembolization has on patients with unresectable hepatocellular carcinoma.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT06946849

/ Not yet recruitingPhase 2IIT

Second-line Regimen Combined With Radiotherapy Versus Without Radiotherapy in Patients With Locally Advanced/Oligometastatic Intrahepatic Cholangiocarcinoma After Failure of First-line Treatment：an Open-label, Randomized, Controlled Phase II Clinical Study

Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study.

Start Date01 Jun 2025

Sponsor / Collaborator-

100 Clinical Results associated with Regorafenib

100 Translational Medicine associated with Regorafenib

100 Patents (Medical) associated with Regorafenib

3,049

Literatures (Medical) associated with Regorafenib

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

Author: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

01 Dec 2025·Journal of Gastrointestinal Cancer

A Systematic Review and Meta-Analysis of the Efficacy and Safety of Regorafenib in the Treatment of Metastatic Colorectal Cancer

Review

Author: Shen, Weizeng ; He, Yue ; Huang, Chao ; Liao, Shengrong ; Tang, Ming ; Liang, Bingjun ; Yang, Yidian

BACKGROUND AND OBJECTIVE:

Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Despite advances in treatment, metastatic colorectal cancer (mCRC) remains a significant challenge due to its heterogeneity and resistance to therapy. Regorafenib, a multikinase inhibitor, can inhibit tumor progression through multiple mechanisms, thereby improving patient prognosis. It has emerged as a potential treatment option for mCRC patients who have progressed on standard therapies. This systematic review and meta-analysis aims to evaluate the efficacy and safety of Regorafenib in this patient population, synthesizing data from clinical trials to provide a comprehensive understanding of its role in mCRC treatment.

METHODS:

A systematic literature search was conducted via the PubMed, Web of Science (WOS), and Embase databases from January 2012 to December 2024. Studies were included if they were randomized controlled trials (RCTs) or clinical trials that reported outcomes of regorafenib treatment in mCRC patients, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Secondary outcomes included the incidence of serious adverse events (SAEs). OS refers to the length of time from the start of treatment until the death of the patient from any cause, while mortality specifically denotes the number of deaths occurring within the study period. Data were extracted by two independent reviewers using a standardized form. The meta-analysis was performed using RevMan 5.0 statistical software.

RESULTS:

A total of 5,082 articles were retrieved, and ultimately, 9 eligible studies involving a total of 2,823 patients were included. All 9 included studies reported OS and PFS. In these mCRC patients, the dose of regorafenib was usually 160 mg daily. The meta results indicated that the OS of patients in the regorafenib group was significantly different [MD = 1.33, 95% CI (0.33, 2.33), P = 0.009]. Eight studies reported the ORR of the disease [OR = 1.13, 95% CI (0.73, 1.76), P = 0.57]. Five studies reported the DCR, and the DCR of patients in the regorafenib group was significantly different from that of patients in the control group [OR = 3.45, 95% CI (2.04, 5.84), P < 0.00001]. The incidence of SAEs (> grade 3) was reported in all 9 included studies [OR = 2.48, 95% CI (1.29, 4.73), P = 0.006].

CONCLUSION:

In this systematic review of prospective trials, regorafenib resulted in improved OS with manageable adverse effects for patients with advanced mCRC. Still, considering the safety, future research should focus on investigating the dose optimization of regorafenib, as well as predictive biomarkers for therapeutic efficacy.

01 Aug 2025·TISSUE & CELL

Regorafenib exerts an inhibitory effect on the proliferation of human lung fibroblasts by reducing the production of several cytokines in vitro study

Article

Author: Tabata, Rie ; Nakamura, Natsuki ; Tabata, Chiharu

BACKGROUND:

Pulmonary fibrosis is a disease that leads to respiratory failure and death. There has been little progress in therapeutic strategies for pulmonary fibrosis. There have been several reports on the cytokines associated with pulmonary fibrosis, including IL-6 and TGF-β₁. Angiogenesis is one of the most important phenomena in the pathogenesis of pulmonary fibrosis. Previously, we reported the preventive effects of thalidomide against pulmonary fibrosis via the inhibition of neovascularization by angiogenic factors such as VEGF. Regorafenib is a multikinase inhibitor, which inhibits tyrosine kinase receptors such as VEGFR1-3 and TIE2. In the clinical setting, regorafenib has been widely used for anti-cancer therapy for metastatic colorectal cancer. In this study, we examined the preventive effects of regorafenib against pulmonary fibrosis.

METHODS:

We investigated whether regorafenib had an inhibitory effect on the proliferation, viability, and production of several cytokines in lung fibroblasts.

RESULTS:

We demonstrated an inhibitory effect of regorafenib on the proliferation and viability of lung fibroblasts. Moreover, regorafenib reduced the production of several cytokines associated with the pathogenesis of pulmonary fibrosis, including IL-6, VEGF and TGF- β₁, and collagen synthesis from lung fibroblasts.

CONCLUSIONS:

These data suggest that regorafenib may have potential clinical applications in the prevention of pulmonary fibrosis.

151

News (Medical) associated with Regorafenib

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

22 May 2025

·www.prnewswire.com

Galmed Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update

TEL AVIV, Israel, May 22, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reports financial results for the three months ended March 31, 2025 and recent developments. Key Recent Developments Announced First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer's Regorafenib Effect in GI Cancer Models Signed Term Sheet for the Development of Novel Semaglutide Sublingual Formulation Raised $6.5 million since the beginning of 2025. Company's current cash balance is $20.1 million Financial Summary – First Quarter 2025 vs. First Quarter 2024*: Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $15.9 million as of March 31, 2025, compared to approximately $15.4 million at December 31, 2024. During May 2025, the Company raised an additional $5.0 million. As a result, as of the date hereof, the Company's current cash balance is approximately $20.1 million. Net loss amounted to approximately $1.1 million, or $0.62 per share, for the three months ended March 31, 2025, compared to a net loss of approximately $1.3 million, or $2.76 per share, for the three months ended March 31, 2024. Research and development expenses amounted to approximately $0.6 million for the three months ended March 31, 2025, compared to approximately $0.6 million for the three months ended March 31, 2024. General and administrative expenses amounted to approximately $0.6 million for the three months ended March 31, 2025, compared to approximately $0.8 million for the three months ended March 31, 2024. The decrease in general and administrative expenses for the three months ended March 31, 2023 resulted primarily from a decrease in professional services expenses. Financial income, net amounted to approximately $0.2 million for the three months ended March 31, 2025, compared to financial income of $0.1 million for the three months ended March 31, 2024. About Galmed Pharmaceuticals Ltd. We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and we are currently seeking to advance the development of Aramchol for oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development. Forward-Looking Statements: Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our product development efforts, business, financial condition, results of operations, strategies or prospects, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believes or anticipate will or may occur in the future. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on April 2, 2025 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. * This unaudited preliminary financial information regarding the company's financial results for the three months and quarter ended March 31, 2025, is based upon the estimates and subject to completion of the company's quarter-end financial results. Moreover, this financial information has been prepared solely on the basis of currently available information by, and is the responsibility of, management. The company's independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to such preliminary estimates or the accounting treatment thereof and does not express an opinion or any other form of assurance with respect thereto. This preliminary financial information is not a comprehensive statement of the company's financial results for this period. Logo: SOURCE Galmed Pharmaceuticals Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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22 May 2025

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Caris Life Sciences to Highlight an Extensive Lineup of Research and Precision Oncology Collaborations at the 2025 American Society of Clinical Oncology Annual Meeting

Caris Life Sciences and the Caris POA collaborators will collectively present 37 abstracts IRVING, Texas, May 22, 2025 /PRNewswire/ -- Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced that the company and collaborators within the Caris Precision Oncology Alliance™ (Caris POA) will collectively present 37 abstracts across 16 tumor types at the upcoming 2025 American Society of Clinical Oncology Annual Meeting, from May 30 – June 3, in Chicago, IL. Continue Reading "This year's ASCO abstracts highlight the growing clinical value of integrated molecular profiling and real world data, particularly as AI tools transform how we diagnose and treat cancer," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The data from our internal and collaborative studies show that we are entering a new era of precision oncology, where every data point can support smarter, more personalized decision-making." Caris Life Sciences and the Caris POA collaborators will collectively present 37 abstracts across 16 tumor types Post this "Caris' strong presence at ASCO demonstrates our ongoing commitment to revolutionizing healthcare and improving patient outcomes," said James Hamrick, MD, MPH, Chairman of the Caris Precision Oncology Alliance. "Caris' comprehensive clinicogenomic database helps enable novel insights into cancer and, together with our network of Caris POA researchers, is truly making an impact on patients' diagnosis, prognosis, care plans and responses to treatment." Oral presentation: CLONEVO: Preoperative abemaciclib for cisplatin-ineligible muscle-invasive bladder cancer (MIBC) with molecular response assessment. (Abstract 4520) May 31, 2:15 – 2:21 PM CDT: Arie Crown Theater Poster presentations: Assessment of age in the clinical risk stratification of patients with IDH-mutant gliomas. Abstract: 2058 Poster Board: 104 May 31, 9:00 AM CDT: Hall A Comparing ERK signaling and tumor microenvironment in BRAF-altered gliomas. Abstract: 2063 Poster Board: 109 May 31, 9:00 AM CDT: Hall A Association of MGMT status with survival in low and high-grade IDH-mutant astrocytomas. Abstract: 2065 Poster Board: 111 May 31, 9:00 AM CDT: Hall A Prognostic impact of DDR mutations (mt) in IDH mutant high-grade gliomas (HGG). Abstract: 2066 Poster Board: 112 May 31, 9:00 AM CDT: Hall A Immune checkpoint inhibition in EBV-associated gastric cancer: A multi-center international retrospective analysis. Abstract: 4043 Poster Board: 333 May 31, 9:00 AM CDT: Hall A Molecular profile of hepatocellular carcinoma (HCC) in older (OA) versus younger adults (YA) receiving tyrosine kinase inhibitors: Does age matter? Abstract: 4124 Poster Board: 414 May 31, 9:00 AM CDT: Hall A The differential effect of stromal genes on gemcitabine/nab-paclitaxel (GN) and GN/cisplatin (GCN) outcomes in advanced pancreatic adenocarcinoma (aPDAC). Abstract: 4166 Poster Board: 456 May 31, 9:00 AM CDT: Hall A Biomarkers of response to immunotherapy in pancreatic ductal adenocarcinoma (PDAC) with homologous recombination deficiency (HRD). Abstract: 4176 Poster Board: 466 May 31, 9:00 AM CDT: Hall A Gamma secretase inhibitors and desmoid fibromatosis: Lessons from a real world, comprehensive genomic study of desmoids and CTNNB1/APC mutated soft tissue tumors. Abstract: 11547 Poster Board: 30 May 31, 9:00 AM CDT: Hall A Unveiling drivers of MHC repression and therapeutic strategies to counter immune evasion in small cell lung cancer. Abstract: 8091 Poster Board: 212 May 31, 1:30 PM CDT: Hall A Clinical outcomes and characterization of HER2 alterations in non-small cell lung cancer (NSCLC). Abstract: 8538 Poster Board: 18 May 31, 1:30 PM CDT: Hall A PRESCIENTai, an AI-based digital histopathological image signature for risk of late distant recurrence and extended endocrine therapy (EET) benefit in hormone-receptor-positive breast cancer. Abstract: 1556 Poster Board: 322 June 1, 9:00 AM CDT: Hall A Interferon signaling and outcomes in triple-negative breast cancer (TNBC) in FinXX, CALGB 40603 (Alliance) and real-world clinico-genomic data. Abstract: 569 Poster Board: 162 June 2, 9:00 AM CDT: Hall A MHC class I expression and outcomes in breast cancer in the real-world clinico-genomic data and the FinXX trial. Abstract: 570 Poster Board: 163 June 2, 9:00 AM CDT: Hall A Evaluation of tumor immune microenvironment in Hispanic and African American breast cancer. Abstract: 1051 Poster Board: 30 June 2, 9:00 AM CDT: Hall A Comparing clinical benefit of trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in a large cohort of HER2-negative metastatic breast cancer (MBC). Abstract: 1076 Poster Board: 55 June 2, 9:00 AM CDT: Hall A Steroid receptor expression and overall survival in breast cancer patients with ER+ bone metastasis: A retrospective review. Abstract: 1077 Poster Board: 56 June 2, 9:00 AM CDT: Hall A Multiomic Profiling of LRRC15 in Triple Negative Breast Cancer (TNBC). Abstract: 1098 Poster Board: 77 June 2, 9:00 AM CDT: Hall A Chemokines as predictive biomarkers for immune checkpoint inhibitor (ICI) benefit in triple negative breast cancer (TNBC). Abstract: 1106 Poster Board: 85 June 2, 9:00 AM CDT: Hall A Comprehensive molecular and immune characterization of adrenergic stress-signaling receptor ADRB2 in triple negative breast cancer (TNBC). Abstract: 1107 Poster Board: 86 June 2, 9:00 AM CDT: Hall A Comprehensive characterization of interleukin-enhanced factor 2 (ILF2) in triple-negative breast cancer (TNBC). Abstract: 1114 Poster Board: 93 June 2, 9:00 AM CDT: Hall A HIF family transcription factor expression in a cohort of 4362 patients with renal cell carcinoma (RCC). Abstract: 4543 Poster Board: 343 June 2, 9:00 AM CDT: Hall A Real-world analysis of 2IR immune response score in histologic subtype urothelial carcinoma (hsUC). Abstract: 4568 Poster Board: 368 June 2, 9:00 AM CDT: Hall A Prevalence of histology-agnostic biomarkers in pure squamous cell carcinomas of the genitourinary tract. Abstract: 4609 Poster Board: 409 June 2, 9:00 AM CDT: Hall A Comprehensive genomic profiling of Black and non-Hispanic White (NHW) men with prostate cancer (PCa). Abstract: 5022 Poster Board: 221 June 2, 9:00 AM CDT: Hall A Effect of HLA class I expression on the tumor immune microenvironment and prognosis in prostate cancer. Abstract: 5044 Poster Board: 243 June 2, 9:00 AM CDT: Hall A Molecular and clinical characterization of KLK2 mRNA expression in prostate cancer (PC). Abstract: 5050 Poster Board: 249 June 2, 9:00 AM CDT: Hall A Prognostic relevance of Aurora kinase A (AURKA) expression in prostate cancer (PCa). Abstract: 5061 Poster Board: 260 June 2, 9:00 AM CDT: Hall A Molecular characterization of STEAP1 and -2 in advanced prostate cancer. Abstract: 5072 Poster Board: 271 June 2, 9:00 AM CDT: Hall A Characterization and impact of B7-H3 (CD276) expression across disease states and racial groups in prostate cancer. Abstract: 5073 Poster Board: 272 June 2, 9:00 AM CDT: Hall A Survival association of PIK3CA in HPV-driven head and neck squamous cell carcinoma (HNSCC). Abstract: 6056 Poster Board: 464 June 2, 9:00 AM CDT: Hall A Comparative transcriptomic analysis to identify similarities and therapeutic vulnerabilities in olfactory neuroblastoma (ONB), sinonasal neuroendocrine carcinoma (SNEC) and sinonasal undifferentiated carcinoma (SNUC). Abstract: 6095 Poster Board: 503 June 2, 9:00 AM CDT: Hall A BRAF -V600E papillary thyroid cancer: Updated analysis of real-world patient data. Abstract: 6099 Poster Board: 507 June 2, 9:00 AM CDT: Hall A Clinical significance of the CGRP pathway gene expression in advanced solid tumors: A sub-analysis of MONSTAR-SCREEN-2. Abstract: 2629 Poster Board: 276 June 2, 1:30 PM CDT: Hall A Effect of elevated expression of LILRB4 and TSC22D3 on survival in lung cancer. Abstract: 2633 Poster Board: 280 June 2, 1:30 PM CDT: Hall A Regorafenib response prediction in metastatic colorectal cancer by a novel genomic and transcriptomic model. Abstract: 3135 Poster Board: 450 June 2, 1:30 PM CDT: Hall A Poster and abstract summaries highlighting this research will be available onsite at Caris' booth #23093. The full abstracts will be available on the Caris website following the presentation. The Caris POA, a community of investigators, includes 97 cancer centers, academic institutions, research consortia and healthcare systems, including 45 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research to improve clinical outcomes for cancer patients. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multimodal database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides a differentiated platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media: Corporate Communications [email protected] 214.294.5606 SOURCE Caris Life Sciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOImmunotherapy

100 Deals associated with Regorafenib

External Link

KEGG	Wiki	ATC	Drug Bank
-	Regorafenib	L01XE21	DB08896

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Liver Cancer	China	Bayer AG	05 Dec 2017
Hepatocellular Carcinoma	European Union	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	Iceland	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	Liechtenstein	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	Norway	Bayer Pharma AG	26 Aug 2013
Colorectal Cancer	Japan	Bayer Yakuhin Ltd.	25 Mar 2013
Gastrointestinal Stromal Tumors	United States	Bayer HealthCare Pharmaceuticals, Inc.	25 Feb 2013
Metastatic Colorectal Carcinoma	United States	Bayer HealthCare Pharmaceuticals, Inc.	27 Sep 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Liver Metastases	Phase 3	China	Sun Yat-Sen University	10 Jun 2023
Glioblastoma	Phase 3	Germany	Bayer AG	06 Sep 2022
Esophageal Carcinoma	Phase 3	United States	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	United States	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	Japan	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	Japan	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	Australia	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	Australia	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	Austria	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	Austria	Bayer AG	01 Jun 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase I trial of regorafenib, ipilimumab, and nivolumab (RIN) (AACR2025)	Phase 1	Metastatic Colorectal Carcinoma Th1-skewed cytokine profile \| immune checkpoint expression \| pathogen-response genes	29	Regorafenib, Ipilimumab, Nivolumab (RIN) Therapy	cqeeslrbjz(blhslypyjc) = eyfgrzhpnp avjcpzgbmo (icepbemaiq ) View more	Positive	30 Apr 2025
NCT03475953 (Pubmed \| Nat Cancer)	Phase 2	Gastro-Enteropancreatic Neuroendocrine Tumor PD1 \| indoleamine 2,3-dioxygenase 1	47	Regorafenib + Avelumab	vyrsetgwul(bqonpmteko) = most common bnbhwpagyv (fiaiafxrrd ) View more	Positive	09 Apr 2025
NCT02365441 (ALT-GIST, Pubmed \| Br J Cancer)	Phase 2	Gastrointestinal Stromal Tumors First line	-	Imatinib	bynipuwgwk(hqongpfrwv) = No Arm A patients stopped protocol therapy due to unacceptable toxicity, with 12 (30.0%) stopping in Arm B ojyazxnihx (xizdufwopn ) View more	Negative	25 Mar 2025
				Imatinib + Regorafenib
NCT04745130 (Pubmed) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma	-	Regorafenib plus Sintilimab	frbxhxrgey(hndfzmfzuk) = ymhisbqfcl rhcjquhwdg (svqsoopokp, 10.5 - 17.7) View more	Positive	10 Feb 2025
				Regorafenib plus Sintilimab (RAS/RAF wild-type)	frbxhxrgey(hndfzmfzuk) = vwjoxomwgw rhcjquhwdg (svqsoopokp, 10.0 - 36.6)
NCT02773524 (INTEGRATE IIa, Pubmed \| J Clin Oncol)	Phase 3	Advanced gastric carcinoma	251	Regorafenib	jgjnsgglqw(uobxdwxosf) = zsyjwkjzpp lodimykbzo (yrrlyateor )	Positive	01 Feb 2025
				Placebo	jgjnsgglqw(uobxdwxosf) = dgjhycxsnq lodimykbzo (yrrlyateor )
SEQRT2 (ASCO_GI2025)	Not Applicable	Metastatic Colorectal Carcinoma	308	Regorafenib	stvownrowa(aspmybjthx) = bmnyndnlyz iyizhcwbtm (qenhnhmxni, 8.4 - 10.3) View more	Positive	23 Jan 2025
				Trifluridine/Tipiracil	stvownrowa(aspmybjthx) = mrkkqvlhia iyizhcwbtm (qenhnhmxni, 7.8 - 9.4) View more
ASCO_GI2025	Not Applicable	Unresectable Hepatocellular Carcinoma Second line	204	Regorafenib alone	wugvqeetfj(srbspeisle) = qkvogzmecf xoietfywea (jctlnlmaeq, 21.98 - 33.42)	Positive	23 Jan 2025
				Regorafenib combined with ICI	wugvqeetfj(srbspeisle) = mlkaqgekpb xoietfywea (jctlnlmaeq )
ESMO_IO2024 Manual	Not Applicable	Unresectable Hepatocellular Carcinoma Second line	33	Regorafenib+PD-1 inhibitor	dwjfsbjzpr(pgiwztzrln) = ydncazwdsc mkxmdeboir (ainhzeeynl ) View more	Positive	12 Dec 2024
				Apatinib+PD-1 inhibitor	dwjfsbjzpr(pgiwztzrln) = hqerfwalve mkxmdeboir (ainhzeeynl ) View more
JPRN-UMIN000040586 (OSERO, ESMO_ASIA2024) Manual	Not Applicable	Metastatic Colorectal Carcinoma Third line	386	Regorafenib-first + FTD/TPI + bevacizumab (Group A)	ppicprwzmh(jbvskqqutu) = krutsotpkn deensmjloe (epbjapwtzf ) View more	Positive	07 Dec 2024
				FTD/TPI + bevacizumab first + regorafenib (Group B)	ppicprwzmh(jbvskqqutu) = qagxavoftx deensmjloe (epbjapwtzf ) View more
ESMO_ASIA2024	Not Applicable	Metastatic Colorectal Carcinoma Third line prognostic nutritional index (PNI)	87	regorafenib (High PNI level)	ncyoyrclqy(jlcrjwoaqh) = mgfyurazqn spppzfcssi (cvtmrcdslr )	Positive	07 Dec 2024
				regorafenib (Low PNI level)	ncyoyrclqy(jlcrjwoaqh) = mzaaipslvs spppzfcssi (cvtmrcdslr )

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