Stivarga (regorafenib) / Amgen, Bayer - LARVOL DELTA

Inhibitors of RAD51 as potential novel therapies in Acute Myeloid Leukemia (ASH 2025) - "Furthermore, these compounds often exhibit strong synergy and at least additivity in combination with both on-label and off-label use of FDA-approved compounds, as well as investigational molecularly-targeted agents, in relevant cell lines; these include FLT3 inhibitors quizartinib, gilteritinib and tuspetinib ((in MV-4-11 and HL60 cell lines) and BCR/ABL inhibitors (imatinib and regorafenib) in the K562 cell line (AACR 2025)...We have confirmed the IBRs inhibit multiple RAD51 functions including hydroxyurea-induced RAD51 focus formation, HRR by DR-GFP assay, and RS protection by RPA focus formation and a DNA fibre assay...JKYN-1 is a partially optimized (more soluble and more potent) version of IBR120 but is not resistant to degradation by liver microsomes or sufficiently capable of entry into target cells...Treatment dose and combinations will be pre-screened using a highly predictive cell line as a surrogate of human cancer stem cells for subsequently AML patient..."

Acute Myelogenous Leukemia • Colorectal Cancer • Hematological Malignancies • Leukemia • Solid Tumor • BRCA1 • BRCA2 • FLT3 • HRD • RAD51

Cost-effectiveness analysis of larotrectinib vs standard of care for treatment of metastatic NTRK fusion colorectal cancer. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "The ICER of larotrectinib therapy vs regorafenib therapy or larotrectinib therapy vs trifluridine/tipiracil therapy was calculated at 23,321.46 USD/QALY or 22,585.39 USD/QALY. From the perspective of healthcare payers in China, larotrectinib was cost-effective compared to standard of care as a second-line treatment or subsequent treatment for advanced or metastatic CRC patients with NTRK gene fusion-positive."

HEOR • Journal • Colorectal Cancer • Oncology • Solid Tumor • NTRK

Imatinib and immunosuppression: an overlooked side effect ? (ESMO Asia 2025) - "An enterocutaneous fistula appeared, leading to a three-month Sunitinib course, but no improvement was observed on follow-up scans...Regorafenib was stopped, and Anti-tuberculosis therapy (ATT) was administered... This case report highlights the challenges posed by the coexistence of recurrent GIST and TB infection in a patient. Imatinib, a cornerstone of GIST therapy, not only targets cancer-specific receptors but also modulates T cell function. While not typically considered a predisposing factor for TB, previous reports have suggested potential associations between Imatinib therapies leading to immune-suppression followed by flaring up of tuberculosis."

Adverse events • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma

Prophylactic effect of diclofenac sodium gel on hand-foot syndrome in patients with gastrointestinal cancer treated with tyrosine kinase inhibitors : A single-center prospective observational study (ESMO Asia 2025) - "Secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, tolerability, and QOL (The HFS-14 questionnaire). Between January 2024 and May 2025, 31 patients were enrolled (median age: 67 years [range: 51-80]; male/female: 58%/42%; performance status [PS] 0/1/2: 36%/61%/3%; primary tumor site: colorectal/hepatocellular carcinoma/gastrointestinal stromal tumor: 77%/16%/7%; TKIs: regorafenib/lenvatinib/fruquintinib/sorafenib/sunitinib: 77%/10%/7%/3%/3%. Diclofenac sodium gel application did not reduce the incidence of TKIs-induced grade ≥2 HFS, compared to than the known reports of capecitabine-induced HFS. However, there were no grade≥ 3 HFS and treatment discontinuation due to HFS. Further research on the preventive effects of diclofenac sodium gel for HFS induced by TKIs is warranted."

Clinical • Observational data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Hepatocellular Cancer • Oncology • Sarcoma • Solid Tumor

Feasibility and evaluation of functional drug sensitivity testing (DST) in relapsed/refractory gastrointestinal cancers (ESMO Asia 2025) - "For example, in a CRC case, Gemcitabine + Paclitaxel (NCV = 0.3269) showed greater sensitivity compared to Fruquintinib (NCV = 0.7987) and Regorafenib (NCV = 0.8225). This study confirms the feasibility of using Optim.AI® in GI cancers, providing interpretable drug sensitivity profile within 7 days. The identification of tumor-specific drug activity highlights the potential of Optim.AI® in guiding treatment decisions when standard options are limited due to disease progression. Further clinical validation is ongoing to establish its clinical concordance in GI cancer setting."

Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Chemotherapy retreatment versus regorafenib in third-line metastatic colorectal cancer: Survival outcomes, prognostic model, and toxicity profile (ESMO Asia 2025) - "Regorafenib is a standard third-line agent, but head-to-head data with retreatment are scarce. Multycentral retrospective analysis of mCRC patients treated with retreatment or regorafenib in 3rd line.Retreatment included prior fluoropyrimidine-, irinotecan-, or oxaliplatin-based chemotherapy plus anti-VEGF or anti-EGFR antibodies. In 3rd line mCRC, retreatment achieved superior OS and PFS vs regorafenib. AE patterns were typical for the above mentioned options."

Metastases • Colorectal Cancer • Oncology • Solid Tumor

Comparison of the efficacy of regorafenib and reintroduction of chemotherapy (CT) with anti-EGFR in the 3rd-line treatment of metastatic colorectal cancer (mCRC) with wild-type RAS and BRAF of left-sided localization - results of a retrospective study (ESMO Asia 2025) - "Compared to regorafenib, reintroduction of a combination of СТ with anti-EGFR in the third-line treatment of pts with left-sided mCRC with wild-type RAS and BRAF is associated with a higher disease control rate and better PFS and 6-month OS."

Metastases • Retrospective data • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Prognostic impact of KRAS mutation subtypes in later-line metastatic colorectal cancer (ESMO Asia 2025) - "In Taiwanese mCRC patients treated with later-line regorafenib or trifluridine/tipiracil, KRAS mutation subtypes demonstrated distinct survival patterns. KRAS G12 mutations were associated with poorer OS, whereas Switch II mutations showed numerically longer OS. Codon- and region-based KRAS classification may provide prognostic insights for later-line therapy."

Metastases • Colorectal Cancer • Oncology • Solid Tumor • KRAS

Stereotactic body radiation therapy to liver improved the efficacy of regorafenib in later-line metastatic colorectal cancer: A multicenter registry study (ESMO Asia 2025) - "In this large multicenter cohort, liver metastases were associated with inferior outcomes in patients receiving regorafenib. However, the addition of liver-directed SBRT significantly improved both TTF and OS, suggesting a potential role for local therapy to enhance systemic efficacy."

Clinical • Metastases • Colorectal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Hyaluronic acid capped cubosomes co-loaded with antitumor agents towards the treatment of colorectal cancer. (PubMed, Sci Rep) - "The purpose of this study was to successfully encapsulate Capecitabine (CAP) and Regorafenib (REG) in liquid crystal nanoparticles or cubosomes (CUBs) matrix for targeting CRC following intravenous (IV) administration. Histopathological studies demonstrated the safety of the HA-REG-CAP-CUBs towards vital organs in an animal model. It is concluded that HA capped CUBs may be suitable carriers for the targeted delivery of combinational antitumor drugs."

Journal • Colorectal Cancer • Oncology • Solid Tumor

A systematic review of cost-effectiveness studies of later-line treatments for refractory metastatic colorectal cancer. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "Later-line treatments were generally not found to be cost-effective compared to BSC, mainly due to high drug costs. No treatment showed consistently favorable results across studies, with outcomes varying by comparator, country, and model settings."

HEOR • Journal • Review • Colorectal Cancer • Oncology • Solid Tumor

Efficacy of regorafenib in patients with advanced biliary tract cancer: An updated systematic review and meta-analysis. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • Retrospective data • Review • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

The efficacy and safety of third-line regorafenib versus fruquintinib in the treatment of metastatic colorectal cancer: A meta-analysis. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • Retrospective data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Regorafenib combined with trifluridine/tipiracil versus regorafenib monotherapy in refractory metastatic colorectal cancer (FDZL-REGOT): A randomized phase 2 trial. (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT05970705 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • Monotherapy • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Regorafenib dose escalation versus fixed dosing in refractory metastatic colorectal cancer: Survival outcomes from a sub-analysis of the ReTrITA study. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Evaluating the correlation between clonal hematopoiesis and response to regorafenib and nivolumab in patients with refractory metastatic colorectal cancer. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Prospective evaluation of zinc, clobetasol, and combination prophylaxis for regorafenib-induced hand-foot skin reaction in colorectal cancer: A subgroup analysis of the ZINCLO-HAND study. (ASCO-GI 2026) - P=N/A | "Clinical Trial Registration Number: NCT06856590 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Impact of codon-level KRAS mutations on response to TAS-102, TAS-102+bevacizumab, or regorafenib in metastatic colorectal cancer. (ASCO-GI 2026) - "Funded by University of Utah Translational Research: Implementation, Analysis, and Design (TRIAD) The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

Combining low-dose regorafenib with pembrolizumab for patients with MSI-H colorectal cancer: REGPEM-CRC-01- HCRN GI23-643. (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT06006923 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • MSI-H • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

Disparate patterns of disease time burden in patients with HCC on immunotherapy or tyrosine kinase inhibitors. (PubMed, JHEP Rep) - "Patients were classified based on the use of immunotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab, and ipilimumab; including monotherapies or combinations) or TKIs (lenvatinib, sorafenib, cabozantinib, and regorafenib)...We demonstrated that immunotherapy was associated with higher DAH compared with tyrosine kinase inhibitor treatment, although this benefit was dampened by the occurrence of immune-related adverse events. These findings have quality-of-life implications and can be used for patient counselling."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Treatment options for senior gastric cancer patients (aged ≥60 years): a worldwide network meta-analysis. (PubMed, Int J Surg) - "pDuFLOT and pSOX are potential regimens among senior patients with resectable gastric cancer. At this moment, pDuFLOT may be globally used while pSOX should better be applied among East Asian countries. CadCAPOX, SuCAPOX, PemCAPOX and NiCAPOX are considered as potential first-line regimens among HER2-negative senior patients. CadCAPOX and SuCAPOX are probably more fit for East Asian patients currently, while NiCAPOX may be better applied among Western countries and PemCAPOX has the potential of worldwide application. SuCAPOX is a potential regimen among HER2-negative/PD-L1-positive senior patients, while PemCAPOX may also be considered. Currently, standard CAPOX or FOLFOX regimen may still be available for HER2-negative senior patients with CLDN18.2, FGFR2b or MET positivity. Meanwhile, among HER2-positive senior patients, TraCAPOX is still considered to be available. Regarding first-line maintenance treatments, RamP is a potential regimen among HER2-negative or..."

IO biomarker • Journal • Retrospective data • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

HEALTHCARE UTILITY AND DISEASE BURDEN IN ADVANCED HEPATOCELLULAR CARCINOMA PATIENTS RECEIVING SYSTEMIC THERAPY (AASLD 2025) - "Patients were classified based on the use of immunotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab, and ipilimumab; including monotherapies or combinations) or TKI (lenvatinib, sorafenib, cabozantinib, and regorafenib)... Immunotherapy, when compared with TKI, was associated with significantly reduced disease time burden in advanced HCC patients in this real-world cohort. However, this difference was mitigated with the occurrence of irAEs. Our data has important quality of life implications, and may influence patients' decisions for therapy."

Clinical • Metastases • Hepatocellular Cancer • Oncology • Solid Tumor

Non-Coding RNAs and cernas: emerging modulators of drug response in colorectal cancer. (PubMed, Mol Biol Rep) - "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...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."

Journal • Review • Colorectal Cancer • Oncology • Solid Tumor

Dr. @AnwaarSaeed3 presents STELLAR-303: Zanzalintinib + atezolizumab shows a significant OS benefit over regorafenib in chemorefractory, MSS mCRC—marking the first I/O-based phase 3 success in this population. @ecancer Watch on #Vumedi: https://tinyurl.com/42jxx89z #CRC #ESMO2025

TACE Plus HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Refractory to Standard Treatment Regimens (clinicaltrials.gov) - P2 | N=21 | Completed | Sponsor: First Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting ➔ Completed | Phase classification: PN/A ➔ P2

Phase classification • Trial completion • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor