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Last update 07 Jul 2026

Regorafenib

Last update 07 Jul 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DAST, fluoro-sorafenib, Regorafenib Hydrate

+ [13]

Target

BRAF V600E x CRAF x CSF-1R x DDR2 x EphA2 x FGFR1 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

BRAF V600E inhibitors, CRAF inhibitors(C-Raf kinase inhibitors), CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [5]

Active Indication

Liver CancerHepatocellular CarcinomaColorectal Cancer+ [26]

Inactive Indication

Acute Myeloid LeukemiaAdenocarcinoma of large intestineAdvanced biliary tract cancer+ [58]

Originator Organization

Bayer AG

Active Organization

Bayer Pharma AG

Bayer AG

Bristol Myers Squibb Co.

+ [7]

Inactive Organization

Merck KGaA

Bayer Healthcare Co., Ltd.Bayer Schering Pharma AG

+ [2]

License Organization

Amgen, Inc.

Bayer Healthcare Co., Ltd.

Onyx Pharmaceuticals, Inc.

+ [9]

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), Special Review Project (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC21H17ClF4N4O4

InChIKeyZOPOQLDXFHBOIH-UHFFFAOYSA-N

CAS Registry1019206-88-2

400

Clinical Trials associated with Regorafenib

NCT06902246

/ WithdrawnPhase 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 Aug 2026

Sponsor / Collaborator

University of Miami

[+1]

ChiCTR2600126996

/ Not yet recruitingPhase 3

A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Regorafenib in Combination with Sintilimab and Radiotherapy versus Regorafenib Monotherapy in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) Who Have Failed at Least Two Prior Tyrosine Kinase Inhibitors Including Imatinib

Start Date01 Jul 2026

Sponsor / Collaborator

Sun Yat-Sen University Cancer Center

NCT07567222

/ RecruitingPhase 1IIT

Safety, Tolerability, and Preliminary Antitumor Activity of Novel Therapeutic Tumor Vaccines in Advanced Solid Tumors

Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms.
Building on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicity observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile.
This is a first-in-human, Phase I, open-label study designed to evaluate the safety and tolerability of this novel vaccine. The study includes multiple arms targeting specific malignancies, including osteosarcoma, pancreatic cancer, HNSCC, colorectal cancer, HCC, glioma, and TNBC.
The primary objective is to determine the incidence of dose-limiting toxicities (DLTs). Secondary objectives include assessing the objective response, progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Exploratory analyses will monitor dynamic changes in circulating biomarkers and intratumoral immune modulation to identify potential predictive markers of clinical response.

Start Date05 Jun 2026

Sponsor / Collaborator

West China Hospital

100 Clinical Results associated with Regorafenib

100 Translational Medicine associated with Regorafenib

100 Patents (Medical) associated with Regorafenib

2,688

Literatures (Medical) associated with Regorafenib

31 Dec 2026·Future Science OA

A comprehensive analysis of the adverse drug events of metastatic and unresectable gastrointestinal stromal tumor treatment options: avapritinib, imatinib, regorafenib, ripretinib, and sunitinib safety insights and implications

Article

Author: Andrews, Michael B. ; Thompson, Cameron M. ; Adler, Douglas G.

BACKGROUND:

Treatments for metastatic, unresectable, or treatment-resistant gastrointestinal stromal tumors (GIST) include avapritinib, imatinib, regorafenib, ripretinib, and sunitinib. The FDA Adverse Event Reporting System (FAERS) database collects medication-related adverse events (AEs).

DESIGN AND METHODS:

Reports in the FAERS database from each medication's FDA approval to June 30, 2025 were analyzed. Reports containing other medications or indications outside of GIST treatment were excluded.

RESULTS:

Avapritinib was associated with fatigue (n = 826, 10.2%), nausea/vomiting (n = 574, 7.1%), eye/facial swelling (n = 631, 7.8%), diarrhea n = 361, 4.5%), peripheral edema (n = 231, 2.5%). Imatinib was associated with nausea/vomiting (n = 677, 4.4%), fatigue (n = 549, 3.6%), anemia (n = 404, 2.6%), abdominal pain (n = 400, 2.6%), and rash (n = 340, 2.2%), hemorrhage (317 AEs, 2.1%). Regorafenib was associated with fatigue (n = 104, 8.6%), palmar-plantar erythrodyesthesia syndrome (n = 66, 5.4%), diarrhea (n = 60, 4.9%). Ripretinib was associated with fatigue (n = 534, 8.4%), alopecia (n = 355, 5.6%), nausea/vomiting (n = 273, 4.3%). Sunitinib was associated with fatigue (n = 420, 6.1%%), nausea/vomiting (n = 284, 4.2%), diarrhea (n = 262, 3.8 %), hemorrhage (n = 149, 2.2%).

CONCLUSIONS:

The FAERS database revealed multiorgan AEs associated with five GIST treatment medications. Novel findings include eye/facial and peripheral edema with avapritinib, palmar-plantar erythrodyesthesia syndrome, headache/migraine, and gait abnormalities across all five medications, pancytopenia with imatinib, and hemorrhage with imatinib and sunitinib.

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Non-Coding RNAs and cernas: emerging modulators of drug response in colorectal cancer

Review

Author: Abkenar, Elahe Daskar ; Sadeghi, Amir ; Mojarad, Ehsan Nazemalhosseini ; Nobili, Stefania ; Shams, Elahe ; Moghani, Mona Malekzadeh ; Sina, Negin ; Ebrahimi, Sara ; Fatemi, Nayeralsadat

Colorectal cancer (CRC) is still one of the most common cancers and a leading cause of cancer morbidity worldwide. A significant issue that should be paid much attention to is its resistance to anticancer agents. Non-coding RNAs (ncRNAs), such as microRNAs (miRNAs), long non-coding RNAs (lncRNAs), and circular RNAs (circRNAs), have been identified as important regulators of drug response and drug resistance in CRC. In this review, we provide a comprehensive assessment of the studies conducted in the field of investigating the role of ncRNAs in drug resistance to prominent anticancer agents used in CRC, including 5-fluorouracil (5-FU), oxaliplatin, cetuximab, bevacizumab, and regorafenib. We focussed specifically on the miRNAs, lncRNAs, and circRNAs associated with resistance to each drug individually, even within the context of combination therapies, such as FOLFOX. We also reviewed competing endogenous RNA (ceRNAs) networks and their relationship with drug sensitivity and resistance and new therapeutic strategies to manage drug resistance in CRC and also analyzed the role of ceRNA networks in modulating drug response and its implications for new approaches to overcome drug resistance in CRC. This article also discusses findings from human clinical trials, highlighting evidence from patient studies that validate the role of targeting ceRNA and ncRNA networks in improving drug sensitivity, overcoming resistance, and enhancing therapeutic outcomes in CRC. It supports the targeting of ncRNA and ceRNA networks as potential therapies to improve treatment outcomes and drug resistance in CRC.

01 Nov 2026·BIOMATERIALS

Regorafenib and R837 nanoparticle-stabilized Pickering emulsions overcome the angiogenesis-immune tolerance axis in transarterial chemoembolization

Article

Author: Yang, Lijuan ; Liu, Hui ; Chen, Hu ; Li, Zhenjie ; Cao, Lei ; Fan, Jun ; Cheng, Hongwei ; Wu, Xiuyi ; Miao, Mengmeng ; Liu, Gang ; Teng, Minglei ; Peng, Yisheng ; Liang, Xiaoliu

Transarterial chemoembolization (TACE) is hindered by the instability of embolic agents, as well as the tumor microenvironment post-embolization, which is characterized by angiogenesis and immune tolerance. Here, we identify a coupled angiogenesis-immune tolerance axis as a key mechanism underlying post-TACE therapeutic resistance. In this study, we developed a novel combination formulation of regorafenib and R837 designed to reprogram the tumor microenvironment following embolization. Using a supercritical carbon dioxide-assisted method, we successfully synthesized carrier-free pure drug nanoparticles of regorafenib and R837, achieving nanoparticles-stabilized lipiodol Pickering emulsions (PE-RR) preparation. This stable formulation not only significantly enhances the embolic stability and sustained drug release, but also effectively reverses post-embolization hypoxia, angiogenesis and immune tolerance through the therapeutic combination of regorafenib and R837. This study demonstrated that locoregional therapy with PE-RR significantly suppressed the hypoxia-angiogenesis signaling axis. These effects are mediated by the coordinated inhibition of angiogenesis (HIF-1α/VEGF axis) and activation of anti-tumor immunity, establishing a mechanistic linkage between vascular normalization and immune reprogramming. By strengthening antigen release and localized delivery of immune agonists, PE-RR facilitated anti-tumor immune activation and improved the therapeutic response to embolization, overcoming the adverse tumor microenvironment associated with conventional lipiodol embolization. Additionally, in bilateral tumor models, PE-RR could boost the therapeutic efficacy of PD-1 checkpoint blockade, increase the generation of anti-tumor immune memory and minimize the low responsiveness of immune checkpoint inhibitors in liver cancer. The stable Pickering embolic emulsion offers an innovative approach for the clinical translation of embolization therapy.

192

News (Medical) associated with Regorafenib

22 Jun 2026

·ir.exelixis.com

Exelixis Provides Update on the Phase 3 STELLAR-303 Trial Evaluating Zanzalintinib in Combination with an Immune Checkpoint Inhibitor in Patients with Metastatic Colorectal Cancer

ALAMEDA, Calif. --(BUSINESS WIRE)--Jun. 22, 2026-- Exelixis, Inc. (Nasdaq: EXEL) today announced results from the final analysis of the dual primary endpoint of overall survival ( OS) in the subset of patients without active liver metastases (non-liver metastases, NLM) in the phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab (Tecentriq®) versus regorafenib in previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (mCRC). The results showed a non-statistically significant trend in OS favoring the combination in the NLM subpopulation (stratified hazard ratio: 0.83; 95% confidence interval: 0.66–1.05; P=0.1185), with median OS values of 15.9 months with zanzalintinib in combination with atezolizumab, and 12.7 months with regorafenib. The safety profile of zanzalintinib in combination with atezolizumab in the NLM subgroup was consistent with that previously reported in the intention-to-treat (ITT) population, and no new safety signals were identified. Exelixis previously announced that STELLAR-303 met its other dual primary endpoint, demonstrating a statistically significant improvement in OS in the ITT population, which included all randomized patients regardless of the presence of active liver metastases. Detailed results demonstrating the statistically significant improvement in OS in the ITT population were presented at the 2025 European Society for Medical Oncology Congress and published in The Lancet . In February 2026 , Exelixis announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab, for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The FDA assigned a Prescription Drug User Fee Act target action date of December 3, 2026 . Detailed findings from the NLM subgroup analysis will be submitted for presentation at an upcoming medical conference. About STELLAR-303 STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high mCRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov. About Zanzalintinib Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes, including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. The zanzalintinib development program includes a series of ongoing and planned pivotal trials to explore its therapeutic potential in CRC, clear cell and non-clear cell renal cell carcinoma, and neuroendocrine tumors, as well as earlier-stage trials in meningioma, lung cancer and castration-resistant prostate cancer. Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials. About CRC CRC is the third most common cancer and a leading cause of cancer-related deaths in the U.S .1 Approximately 159,000 new cases will be diagnosed in the U.S . in 2026, with around 55,000 expected deaths from the disease.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is around just 15%.1,2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.3 About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our pipeline of franchise molecules, including our novel oral kinase inhibitor zanzalintinib, and to extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: the presentation of detailed results from the STELLAR-303 NLM subgroup analysis at an upcoming medical conference and Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the referenced times; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere, including with respect to Exelixis’ NDA for zanzalintinib for the treatment of patients with previously treated metastatic CRC, when used in combination with atezolizumab, including the risk that the FDA may not approve zanzalintinib as a treatment for metastatic CRC in a timely fashion, if at all; Exelixis’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating zanzalintinib; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of zanzalintinib; Exelixis’ ability to protect its intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting Exelixis and its development programs detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis. TECENTRIQ is a registered U.S. trademark of Genentech, a member of the Roche Group. View source version on businesswire.com: https://www.businesswire.com/news/home/20260621469249/en/ Investors Contact: Andrew Peters SVP, Strategy and Investor Relations Exelixis, Inc. 650-837-7248 apeters@exelixis.com Media Contact: Stekki Millman Senior Director, Public Affairs Exelixis, Inc. 650-837-7187 smillman@exelixis.com Source: Exelixis, Inc.

Clinical ResultPhase 3NDA

22 Jun 2026

·allsci.com

Exelixis reports split Phase III outcome for zanzalintinib ahead of FDA review

Exelixis, Inc. (Nasdaq: EXEL) reported that the final analysis of its second dual primary endpoint in the Phase III STELLAR-303 trial did not reach statistical significance, revealing a split result that creates uncertainty around how FDA will interpret the totality of evidence ahead of a December 2026 decision date. The trial, which evaluated zanzalintinib in combination with Genentech’s atezolizumab versus Bayer’s Stivarga (regorafenib) in previously treated non-MSI-high metastatic colorectal cancer, carried two co-primary overall survival endpoints: one in the full intention-to-treat population and one in patients without active liver metastases at baseline. Exelixis previously reported that the ITT endpoint was met, with data presented at the 2025 European Society for Medical Oncology Congress and published in The Lancet. The non-liver metastases subgroup, however, produced a hazard ratio of 0.83 (95% CI: 0.66–1.05; P\=0.1185) — a numerical trend in the right direction but short of the pre-specified threshold for statistical significance. Median OS was 15.9 months with zanzalintinib plus atezolizumab versus 12.7 months with regorafenib in that subgroup. The regulatory question The FDA accepted Exelixis’s New Drug Application in February 2026, with a PDUFA date of December 3, 2026. The submission covers the broader previously treated mCRC population, not the NLM subgroup alone. That the ITT endpoint was met provides the foundation for the application. Whether the failure of the NLM subgroup to achieve statistical significance creates a labeling complication, or prompts agency questions about the consistency of benefit across patient subsets, is the central uncertainty now facing the program. The NLM subgroup result is not trivial in clinical terms. Liver metastases in colorectal cancer are associated with an immunosuppressive microenvironment that substantially limits checkpoint inhibitor activity — a well-documented phenomenon that has shaped trial design in this space. The hypothesis underpinning the NLM subgroup endpoint was that patients without liver involvement would derive the greatest benefit from immune checkpoint inhibition. The observed hazard ratio of 0.83 is directionally consistent with that hypothesis, but the confidence interval crossing 1.0 means the data do not statistically confirm it. Zanzalintinib is an oral inhibitor of the TAM kinases (TYRO3, AXL, MER), MET, and VEGF receptors. The mechanistic rationale for combining it with atezolizumab rests on its potential to reduce immune evasion through TAM kinase blockade and to suppress angiogenesis, thereby creating a more permissive tumor microenvironment for checkpoint inhibitor activity. The safety profile in the NLM subgroup was consistent with the ITT population, with no new signals identified. Competitive context Beyond mCRC, zanzalintinib is a central component of Exelixis’s broader development strategy and is being evaluated in multiple studies under the company’s collaboration with Merck focused on combinations with Keytruda. Their initial 2024 partnership focused on head and neck cancer and renal cell carcinoma indications, and was expanded to include resected colorectal cancer in May 2026. While STELLAR-303 is specific to metastatic colorectal cancer, regulatory interpretation of the program may influence perceptions of the asset’s broader commercial and clinical potential. Exelixis has indicated that detailed NLM subgroup data will be submitted for presentation at an upcoming medical conference. The key question is whether the FDA views the positive ITT overall survival result as sufficient to support approval in the broader population sought by Exelixis, despite the failure of the second co-primary endpoint to achieve statistical significance. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Clinical ResultPhase 3

08 Jun 2026

·allsci.com

Oricell’s GPC3 CAR-T advances to Phase II trial in hepatocellular carcinoma

Shanghai-based Oricell Therapeutics Holdings Limited announced that its GPC3 CAR-T therapy, Ori-C101, has received clearance from China’s National Medical Products Administration to proceed into a confirmatory Phase II randomised registration trial in patients with GPC3-positive advanced hepatocellular carcinoma who have failed at least two prior lines of therapy. The clearance positions Ori-C101 as the first GPC3-directed immune cell therapy globally to enter a confirmatory trial and the first CAR-T product for a liver cancer indication to reach a Phase II randomised controlled study. Ori-C101 is a GPC3-targeted autologous CAR-T therapy engineered to redirect T cells against glypican-3, a cell-surface proteoglycan overexpressed in more than 70% of hepatocellular carcinomas. The confirmatory trial milestone follows Phase I BEACON study data presented as an oral presentation at the 2026 American Society of Clinical Oncology Annual Meeting, and comes roughly two months after Oricell closed a pre-IPO financing round exceeding USD 110 million co-led by Vivo Capital and Qiming Venture Partners to fund global clinical development. The BEACON study enrolled patients with advanced HCC who had failed at least two prior lines of systemic therapy, including both tyrosine kinase inhibitors and immune checkpoint inhibitors. As of the April 2026 data cutoff, 18 patients were evaluable for efficacy. The overall objective response rate was 50% across the evaluable population, rising to 66.7% in the recommended Phase II dose cohort and 100% in the highest dose cohort. Of responders, 89% had achieved objective response by their first post-infusion assessment. Median overall survival in the overall population was 21.4 months, with a 12-month survival rate of 69.3% — compared with a historical median of approximately 10.6 months with available second-line agents. Competitive context While CAR-T therapies have transformed several blood cancers they have struggled to demonstrate durable efficacy in solid tumors because of antigen heterogeneity, tumor microenvironment barriers, and limited T-cell persistence. The GPC3 target has attracted multiple development programs across modalities, but Ori-C101 is the only candidate to reach a confirmatory randomized trial. The closest competitor in the GPC3 CAR-T space is AstraZeneca’s C-CAR031, an armored autologous GPC3 CAR-T co-developed with AbelZeta Pharma that reported a 56.5% ORR across all dose levels in a Phase I study presented at ASCO 2024, with a 75% ORR at the highest dose level — though that program remains in early-phase development. AstraZeneca acquired full global rights to C-CAR031 from AbelZeta in January 2026 for up to USD 630 million, signaling the commercial value attributed to GPC3-directed cell therapy in HCC. The current approved second-line options for advanced HCC — Bayer’s Stivarga (regorafenib), Exelixis’s Cabometyx (cabozantinib), and Eli Lilly’s Cyramza (ramucirumab) — were developed primarily for patients progressing after first-line sorafenib and carry modest efficacy profiles, with objective response rates typically below 10–15% in pivotal trials. No therapy has been approved specifically for patients who have progressed through both checkpoint inhibitor-based regimens and tyrosine kinase inhibitors, the population enrolled in BEACON. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Cell TherapyPhase 1ImmunotherapyASCOPhase 2

100 Deals associated with Regorafenib

External Link

KEGG	Wiki	ATC	Drug Bank
-	Regorafenib	L01XE21	DB08896

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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	05 May 2021
Esophageal Carcinoma	Phase 3	United States	Bristol Myers Squibb Co.	05 May 2021
Esophageal Carcinoma	Phase 3	Japan	Bayer AG	05 May 2021
Esophageal Carcinoma	Phase 3	Japan	Bristol Myers Squibb Co.	05 May 2021
Esophageal Carcinoma	Phase 3	Australia	Bayer AG	05 May 2021
Esophageal Carcinoma	Phase 3	Australia	Bristol Myers Squibb Co.	05 May 2021
Esophageal Carcinoma	Phase 3	Austria	Bayer AG	05 May 2021
Esophageal Carcinoma	Phase 3	Austria	Bristol Myers Squibb Co.	05 May 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03657641 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	73	regorafenib+Pembrolizumab (Phase I, Dose Level 1)	piusduxfax = zvpnrcufkl qftgwfgfxd (jidhtfrwqd, cyvvzqxvtx - vokylztgpz) View more	-	16 Jun 2026
				regorafenib+Pembrolizumab (Phase I, Dose Level 2)	piusduxfax = fliqqmtrox qftgwfgfxd (jidhtfrwqd, uoxlahjscq - tirautjqmk) View more
NCT04879368 (INTEGRATE IIb \| INTEGRATEIIb, CTgov)	Phase 3	Esophageal Carcinoma \| Refractory Cancer	462	Nivolumab+Regorafenib (RegoNivo)	waikjxqwvs(plrcyjsneq) = fdhkxrmwzh hngdydpakj (yclhqkxeaw, njnfxzbtzm - kkomqoziwa) View more	-	10 Jun 2026
				Trifluridine/Tipracil+Paclitaxel+Docetaxel+Irinotecan (Standard of Care)	waikjxqwvs(plrcyjsneq) = sygeabluib hngdydpakj (yclhqkxeaw, eqmrefvlje - fizftfeqts) View more
ChiCTR1900026961 (ASCO2026)	Phase 4	RAS Wild Type Colorectal Cancer RAS wild-type	68	Cetuximab plus irinotecan	vbtqoulasp(nxttehiwku) = zfrnvvohbx wvrxtqprgf (oajttlucwz ) View more	Positive	29 May 2026
				Regorafenib	qxcphryogd(avowwjgsdv) = jdrmenukto vcqqtjnczb (jkmjzdurpf ) View more
NCT01900743 (REGOSARC, ASCO2026)	Phase 2	Advanced Sarcoma	355	Regorafenib	mvbivhrxwg(uutlaqfkxh) = icbsyivxsg rvofiyhywu (yeeuezulgx, 11.1 - 17.9) View more	Positive	29 May 2026
				Placebo	mvbivhrxwg(kiolpuabqy) = shjacxgkkd relsfuacsu (pszteybiso, 7.7 - 12.4)
NCT03475953 (REGOMUNE, ASCO2026)	Phase 2	HPV-related carcinoma HPV-associated	44	Regorafenib + Avelumab	ymutcznizh(rrwelbbnur) = vhadypshov xjtnsbhzys (ddoycqixkw, 30.5 - 61.1) View more	Positive	29 May 2026
REGOMA-COL (ASCO2026)	Not Applicable	Recurrent Glioblastoma	26	Regorafenib	emhckhxcrz(qialtcoysg) = Toxicity was predominantly low-grade, with fatigue, mucositis, and diarrhea as the most common adverse events. ferddxxcug (eizrkfzxay )	Positive	29 May 2026
ChiCTR2300077213 (C-ooperate/SCOG-C001, ASCO2026)	Phase 2	Advanced Colorectal Adenocarcinoma Third line	30	Regorafenib 120 mgChidamide 20 mgFruquintinib 5 mg + Regorafenib 120 mgChidamide 20 mgg/kgFruquintinib 5 mg + Regorafenib 120 mgChidamide 20 mg mg or Fruquintinib 5 mg (pMMR/MSS + Advanced Colorectal Cancer)	fkryrbmmjv(aykksultac) = qsozzpiddi rutdcdkyis (dumrqzridl, 2.4 - 30.2) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Metastatic Colorectal Carcinoma Third line	51	TAS-102+Regorafenib	gabksvugcz(azhdeebyfj) = ekketxsrex oqngrpdwpg (qoqwyoypuw, 388.75 - NR) View more	Positive	29 May 2026
				TAS-102+Bevacizumab	gabksvugcz(azhdeebyfj) = djpqtviorf oqngrpdwpg (qoqwyoypuw, 34.74 - NR) View more
ESMO_SRC2026	Not Applicable	SDH-deficient Gastrointestinal Stromal Tumors	19	imatinib	fhdtawaxpt(rhxromjcfo) = qfegtortwr udimamkdfh (bwgokgkijg, 50.7 - NR)	Positive	09 Mar 2026
				sunitinib	kgbagwpktq(bsbvzmamje) = byocjjwxdo gmawfayycw (cnyugytfgx )
NCT04327700 (CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	2	TheraBionic+Regorafenib	qsviogphfu = ddsccjhbbz mtdlkrmyrk (tviapmybzm, kthctottiu - rutotcoqqw) View more	-	05 Mar 2026

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