Stivarga (regorafenib) / Amgen, Bayer - LARVOL DELTA

Zanzalintinib plus atezolizumab (zanza + atezo) vs regorafenib (rego) in patients (pts) with previously treated metastatic colorectal cancer (mCRC): Primary overall survival (OS) analysis from the randomized, open-label, phase III STELLAR-303 study (ESMO 2025) - P3 | "Conclusions Zanza + atezo significantly improved OS vs rego with no new safety signals, representing a potential new treatment option for pts with previously treated mCRC. The trial continues to the final OS analysis in the nlmITT population."

Clinical • Late-breaking abstract • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • AXL • MSI

FOLFOX Plus Bevacizumab Rechallenge Versus Regorafenib as Third-Line Treatment in Metastatic Colorectal Cancer: The Role of the Oxaliplatin-Free Interval. (PubMed, Cancers (Basel)) - "All patients had received first-line FOLFOX plus cetuximab or panitumumab, followed by FOLFIRI plus bevacizumab after progression...OFI was associated with PFS in a nonlinear manner, but there was no robust evidence that it modified the relative treatment effect across its continuous range. Exploratory subgroup findings based on a 6-month cutoff require external validation."

Journal • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS

Systemic Therapy for Advanced Hepatocellular Carcinoma with Impaired Liver Function: Navigating the Evidence Gap. (PubMed, Cancers (Basel)) - "Cohort 5 of the CheckMate 040 nivolumab trial included selected patients with CTP-B7/B8 disease and demonstrated modest efficacy, with an objective response rate of 12% and a median overall survival of 7.6 months. Additionally, the phase 3b single-arm SIERRA study reported a manageable safety profile for durvalumab plus tremelimumab (STRIDE regimen) in the CTP-B population. In contrast, regimens incorporating vascular endothelial growth factor (VEGF) inhibition, such as atezolizumab-bevacizumab and tyrosine kinase inhibitors (TKIs), may require cautious use due to an increased risk of bleeding or hepatic decompensation. TKIs, including sorafenib, lenvatinib, regorafenib, and cabozantinib, are metabolized by hepatic CYP450 pathways and require careful patient selection, monitoring, and dose optimization...Decreased liver reserve represents a heterogeneous clinical state, and treatment benefits depend on maintaining treatment duration without precipitating hepatic..."

Journal • Review • Cardiovascular • CNS Disorders • Fibrosis • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Liver Failure • Oncology • Portal Hypertension • Solid Tumor

Pooled Individual Patient-Data Analysis of Clinical Trials on Second-line Multikinase Inhibitors Following Immunotherapy in Hepatocellular Carcinoma. (PubMed, JHEP Rep) - "The current study provides the largest prospective data on second-line MKIs in patients with HCC who had prior first-line immunotherapy. Given the strong prognostic signal of MVI observed in this analysis, our data suggest considering MVI, rather than prior response to immunotherapy or EHS, as a stratification factor for future second-line trials."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

DONSON links tumor-cell survival to MIF-associated macrophage remodeling in small cell lung cancer. (PubMed, Apoptosis) - "Regorafenib alters the thermal stability of endogenous DONSON and enhances anti-PD-1 activity in syngeneic SCLC models, accompanied by increased proportions of CD86-positive macrophages and IFN-γ-positive CD8+ T cells. These findings implicate a DONSON-associated p38-MIF programme in neuroendocrine SCLC and tumor-macrophage crosstalk, nominating this pathway for further therapeutic investigation."

IO biomarker • Journal • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • CD8 • CD86 • IFNG • MIF

Efficacy and Safety of Regorafenib Maintenance Therapy in Patients with Metastatic Colorectal Cancer (mCRC) without Imaging Progress after Second-Line Treatment(RE-SUSTAIN) (ESMO 2026) - No abstract available

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor

Trifluridine-tipiracil plus regorafenib versus trifluridine-tipiracil plus bevacizumab in refractory metastatic colorectal cancer (ESMO 2026) - No abstract available

Metastases • Colorectal Cancer • Oncology • Solid Tumor

Real-World Evidence of Trifluridine/Tipiracil plus Bevacizumab versus Regorafenib in Refractory Metastatic Colorectal Cancer: A Systematic Review and Meta-analysis (ESMO 2026) - No abstract available

HEOR • Metastases • Real-world • Real-world evidence • Retrospective data • Review • Colorectal Cancer • Oncology • Solid Tumor

From Cure to Recurrence: Very Early Metastatic Hepatocellular Carcinoma After Living Donor Liver Transplantation (ACG 2026) - "Sequential TKI therapy with lenvatinib and cabozantinib was limited by progression and toxicity. With AFP now >500 ng/mL, ramucirumab or regorafenib are under consideration...(B) Pankeratin (panCK) immunostain highlighting tumor cells. Original magnification Ã500."

Metastases • Cardiovascular • Fibrosis • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Portal Hypertension • Solid Tumor • Transplantation

EUS-RFA for Refractory Recurrent Gastric Gastrointestinal Stromal Tumor: A Novel Therapeutic Approach (ACG 2026) - "Pathology confirmed GIST, and adjuvant imatinib was initiated...Despite sequential therapy with sunitinib and regorafenib, imaging showed recurrent perigastric nodules...Although radiofrequency ablation has been described for metastatic GIST, particularly hepatic lesions, data regarding EUS-RFA for localized recurrent gastric GIST remain limited. Larger studies are needed to evaluate long-term oncologic outcomes and define the role of EUS-RFA in the management algorithm for recurrent GIST."

Stroma • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Hematological Disorders • Hepatology • Oncology • Sarcoma • ANO1 • KIT

Progression-Free Survival With Second, Third, and Fourth Line Tyrosine Kinase Inhibitors After Imatinib Failure in Gastrointestinal Stromal Tumors: A Genetic Mutation-Stratified Systematic Review and Meta-Analysis (ACG 2026) - "Masitinib did not improve PFS versus sunitinib. In the VOYAGER trial, avapritinib did not improve progression-free survival compared with regorafenib in the overall study population, but it showed activity in patients with PDGFRA D842V mutations... 11 randomized trials including 2,181 patients with advanced gastrointestinal stromal tumors after imatinib failure were included. Overall, active TKIs significantly improved progression-free survival (PFS) compared with placebo or best supportive care (HR 0.32, 95% CI 0.21â0.51) although heterogeneity was substantial. Sunitinib, regorafenib, ripretinib, pazopanib, and imatinib rechallenge showed benefit in delaying disease progression compared with placebo or best supportive care, whereas Nilotinib did not with best supportive care, with or without imatinib or sunitinib."

Retrospective data • Review • Stroma • Gastrointestinal Stromal Tumor • Oncology • Sarcoma • KIT • PDGFRA

Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study. (PubMed, J Clin Oncol) - P3 | "In patients with pMMR or not MSI-H mCRC that had progressed on previous therapy, there was no statistically significant improvement in OS after lenvatinib plus pembrolizumab treatment versus SOC. No new safety signals were observed."

Journal • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Lenvatinib plus pembrolizumab versus standard of care for previously treated metastatic colorectal cancer (mCRC): the phase 3 LEAP-017 study (ESMO-GI 2023) - P3 | "We present results from the global, randomized, open-label phase 3 LEAP-017 study (NCT04776148) evaluating the efficacy and safety of lenvatinib + pembrolizumab versus standard-of-care (SOC) in previously treated non-MSI-H/dMMR mCRC. Eligible pts aged ≥18 years with unresectable, non-MSI-H/dMMR mCRC that had progressed on or was intolerant to prior treatment including fluoropyrimidine, oxaliplatin, irinotecan and targeted therapies such as anti-VEGF/EGFR mAbs, or BRAF-inhibitors, were randomized 1:1 to lenvatinib 20 mg orally QD + pembrolizumab 400 mg IV Q6W or investigator's choice (selected before randomization) of oral regorafenib 160 mg QD (d 1-21, no dose on d 22-28 [cycle 1 dose escalation from 80 mg QD permitted as per local guidelines]) Q4W or trifluridine/tiparicil 35 mg/m2 Q4W (BID on d 1-5 and d 8-12, no doses on d 6-7 or d 13-28 [SOC]). Treatment with lenvatinib + pembrolizumab versus SOC trended toward longer OS, PFS, and ORR, but did not meet..."

Late-breaking abstract • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR • MSI

Hepatocellular Carcinoma with Pulmonary Metastasis Two Years After Liver Transplantation: A Case Report and Multidisciplinary Management (TTS 2026) - "Post-transplant immunosuppression initially included tacrolimus, mycophenolate mofetil, and prednisone, which was later tapered to a dual regimen of tacrolimus and mycophenolate mofetil...Subsequently, the patient underwent percutaneous radiofrequency ablation of a dominant pulmonary nodule and was initiated on oral lenvatinib...Subsequent treatment modifications included a switch to regorafenib and the addition of traditional Chinese medicine (Huaier granule, followed by a personalized decoction containing Astragalus, Pinellia, Coptis, Zingiber, Ginseng, Atractylodes, Aurantii, Cinnamomum, Paeonia, Poria, Agrimonia, and Psoralea)... This case highlights the critical importance of heightened vigilance for recurrent malignancy in LT recipients, particularly those with a prior history of HCC. Comprehensive surveillance incorporating regular imaging and tumor markers facilitates early detection of metastatic disease. A multidisciplinary and individualized treatment strategy..."

Case report • Clinical • Fibrosis • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Solid Tumor • Transplantation • AFP • FER • GPC3

Multi-target Drug Discovery for Cancer Therapy: A Contemporary Review. (PubMed, Recent Pat Anticancer Drug Discov) - "MKIs and bispecific antibodies represent transformative modalities in modern oncology, supported by robust clinical evidence and extensive patent activity."

IO biomarker • Journal • Fibrosarcoma • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thyroid Gland Carcinoma • FGFR • RET

Target Attainment and Clinical and Biochemical Parameters Associated with the Pharmacokinetics of 12 Tyrosine Kinase Inhibitors. (PubMed, Clin Pharmacokinet) - "Target attainment was suboptimal for most TKIs, supporting the need for TDM-guided optimisation and individualised dosing. Associations between TKI exposure and renal, hepatic, and haematological parameters further support personalised treatment strategies."

Journal • PK/PD data • Hematological Disorders • Oncology

Grünenthal…announced an agreement with Bayer AG to acquire Stivarga, an oral treatment for specific advanced cancers, for up to €375 million. (PRNewswire) - "The acquisition is subject to customary closing conditions, including approval by the relevant regulatory authorities. The acquisition is expected to close by the end of 2026 or early 2027....Loss of exclusivity for Stivarga is anticipated in 2029 in the European Union and in 2030 in the United States (US)."

M&A • Patent expiry • Colorectal Cancer • Gastrointestinal Stromal Tumor • Hepatocellular Cancer

LENVAGIST: A multicentre, comparative, placebo (P)-controlled, double-blinded, phase II study of the efficacy of Lenvatinib (L) in patients with advanced GIST after failure of imatinib and sunitinib (ESMO 2024) - P2 | "Background: In advanced GIST, imatinib, then sunitinib, regorafenib and ripretinib are the usual sequence in 1st, 2nd, 3rd and 4th line, respectively. The LENVAGIST study met its primary endpoint. Lenvatinib leads to clinical benefits in pts presenting advanced GIST after failure of available TKIs."

Clinical • Late-breaking abstract • Metastases • P2 data • Oncology • Solid Tumor • FGFR1 • FLT1 • PDGFRA

Investigating Real-World Tolerance and Dose Reductions of Oncology Multikinase Inhibitors in a VA Population. (PubMed, Fed Pract) - "Individual mean RDIs were 71.0% for axitinib, 59.6% for cabozantinib, 63.7% for lenvatinib, 82.3% for pazopanib, 61.2% for regorafenib, 49.0% for sorafenib, and 85.5% for sunitinib...Oncology MKI therapies used at VANTHCS were difficult for veterans to tolerate and ultimately led to suboptimal dosing. Clinicians may use these data to guide decision-making when initiating and managing MKI agents in this population."

Journal • Real-world evidence • Hematological Disorders • Oncology

PULSAR Combined With Fecal Microbiota Transplantation for Advanced Hepatocellular Carcinoma Progressing After First-Line Targeted-Immunotherapy (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Wang Xin | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor • Transplantation

ON-Going Care in mCRC: Strategies for Long-Term Disease Control with Bevacizumab Combination Therapy (IASGO 2026) - "In refractory mCRC, the SUNLIGHT trial showed that trifluridinetipiracil plus bevacizumab improved overall and progression-free survival compared with trifluridinetipiracil alone. Regorafenib and fruquintinib remain additional later-line options for appropriate patients.Tolerability, marrow reserve, organ function, performance status, and patient preference should guidesequencing. A case with prolonged disease control across bevacizumab-FOLFIRI, surgery, bevacizumab-FOLFOX,radiotherapy, and later-line therapy demonstrates the value of coordinated sequential decisions.Korean post-marketing experience with the SB8 bevacizumab biosimilar (ONBEVZI) providessupportive real-world information and may help expand access. The goal is not simply to maximize oneregimen's duration, but to preserve function and deliver active therapy across the entire disease course."

Combination therapy • Colorectal Cancer • Solid Tumor • BRAF

High-grade gliomas H3G34-mutant in pediatric and AYA population: a single center experience (EANO 2026) - "First-line chemotherapy included Nimotuzumab/Vinorelbine regimen (NV) (3/12), NV plus Temozolomide (TMZ) (4/12), TMZ alone (3/12), and TMZ plus Bevacizumab (1/12).Best response included partial response in 3/12 and stable disease in 1/12...At progression, one patient received re-irradiation and NV; 4/8 received second-line strategies, including TMZ plus Regorafenib (1/4), TMZ plus sirolimus (1/4), Nivolumab (1/4) and Bevacizumab (1/4), with limited impact on long-term outcomes... Although limited in size, this case series underscores the poor prognosis of HGG G34 in pediatric and young adult patients, characterized by infiltrative growth, restricted surgical resectability, and suboptimal response to current treatment modalities. These findings highlight the urgent need for the development of novel therapeutic strategies and more effective molecularly targeted approaches to address this rare yet highly aggressive malignancy."

Clinical • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor • CHEK2 • MSH3 • NBN • POLD1

Computational Repurposing of FDA-Approved Drugs as Candidate MMP2 Inhibitors with Putative MMP3 Cross-Activity. (PubMed, Int J Mol Sci) - "Among them, Regorafenib (S1178) and Capmatinib (S2788) showed the most favorable cross-target profiles and were further supported by MD analysis. From these findings, S1178 and S2788 were proposed as promising MMP2-prioritized compounds with potential MMP3 cross-activity, warranting further experimental validation as candidate antifibrotic MMP modulators."

FDA event • Journal • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • MMP2 • MMP3

O-GlcNAc transferase inhibition sensitizes multiple myeloma cells to regorafenib via G0/G1 cell cycle arrest. (PubMed, Leuk Res) - No abstract available

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Real-World Efficacy and Safety of Tyrosine Kinase Inhibitors in Patients With Advanced Bone Sarcomas: The TOGBONE Study of the Turkish Oncology Group. (PubMed, JCO Glob Oncol) - "In this real-world cohort, although TKIs were associated with limited survival outcomes, they had an acceptable safety profile in patients with advanced bone sarcomas. These findings are consistent with the results of phase II studies and suggest that TKIs may be a treatment option for patients who have disease progression after standard therapies."

Journal • Real-world evidence • Retrospective data • Ewing Sarcoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor