Fruzaqla (fruquintinib) / Eli Lilly, Hutchmed, Takeda - LARVOL DELTA

Chemotherapy, targeted therapy and immunotherapy of metastatic colorectal cancer : What is new? (PubMed, Radiologie (Heidelb)) - "For patients who no longer respond to treatment, the new standard trifluridine/tipiracil in combination with bevacizumab has become established as the new third-line option. Furthermore, the selectively anti-angiogenic tyrosine kinase inhibitor fruquintinib has recently been approved as a last-line treatment. This article provides an overview of current standards and future developments in therapy."

IO biomarker • Journal • Review • Colorectal Cancer • Hematological Malignancies • Leukemia • Microsatellite Instability • Oncology • Sarcoma • Solid Tumor • BRAF • EGF • HER-2 • KRAS • MSI

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer. (PubMed, J Med Econ) - "BackgroundNew 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. Sensitivity and scenario analyses were conducted to address these limitations.ConclusionReDO 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."

HEOR • Journal • Colorectal Cancer • Oncology • Solid Tumor

Real-world evidence of fruquintinib (Fruq) efficacy after regorafenib (Rego) and trifluridine–tipiracil (TAS-102) in refractory metastatic colorectal cancer (mCRC). (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Colorectal Cancer • Oncology • Solid Tumor

Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor

EMB-01, an EGFR/cMET bispecific antibody, in metastatic colorectal cancer: Results from an international phase Ib/II study (AACR 2025) - P1/2 | "The median lines of prior systemic therapies were 3 (range 1-11), with 66.7% having received prior anti-EGFR therapy, 79.2% anti-VEGF therapy, and 27.1% fruquintinib, regorafenib, or trifluridine/tipiracil (TAS-102). EMB-01 demonstrated promising efficacy in heavily pretreated mCRC, including those with prior progression on anti-EGFR, with an acceptable safety profile at 1600 mg, warranting further investigation in larger cohorts.References: 1. Ren et al. Cancer Res 2020; 80(16 Suppl): Abstract 528."

Metastases • P1/2 data • Colorectal Cancer • Oncology • Solid Tumor

Overall survival based on sequencing of fruquintinib, regorafenib, and TAS-102 with or without bevacizumab in treatment-refractory metastatic colorectal cancer. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor

Disitamab vedotin combined with fruquintinib in patients with HER2-expressing or HER2 mutation/amplified metastatic colorectal cancer refractory to at least two standard regimens: A prospective, exploratory, single-arm study. (ASCO 2025) - P4 | "Clinical Trial Registration Number: NCT05661357 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor • HER-2

Tyrosine kinase inhibitor (TKI) plus PD-1 blockade in TKI-responsive MSS/pMMR metastatic colorectal adenocarcinoma (mCRC): Results of a multicenter, phase II trial (TRAP) (AACR 2025) - P2 | "TRAP (NCT04483219) aims to explore the efficacy and safety of antiangiogenic TKIs combined with PD-1 blockade in TKI-responsive MSS/pMMR mCRC pts refractory to standard treatment. Eligible pts were given 1 cycle of TKIs (fruquintinib 5mg or regorafenib 120mg, d1-21, q4w) and grouped by tumor response according to RECIST v1.1: arm A: reduction of target lesion to CR, PR or shrunken SD, or cavitation in metastatic lung lesions, or decrease in the density of liver metastatic target lesions ≥15%; arm B: enlarged SD; arm C: PD...Pts in arm A then received TKIs plus anti-PD-1 antibody (toripalimab 240mg, or sintilimab 200mg, i.v.gtt, q3w, until PD or up to 2 years), pts in arm B continued with TKIs until PD... TKIs combined with PD-1 blockade has shown encouraging efficacy with acceptable toxicities in MSS/pMMR mCRC pts responsive to TKI treatment. The regimen could be a preferred approach in pretreated MSS/pMMR mCRC."

Clinical • IO biomarker • Metastases • P2 data • pMMR • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • KRAS

Phase Ib/II study of fruquintinib (F) combined with capecitabine (C) as maintenance therapy (MT) for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) after first-line treatment with cetuximab combined with chemotherapy (AACR 2025) - "The RP2D of F was 5 mg/d on days 1-14 in this study. Our preliminary results showed that the efficacy of F combined with C is promising with well tolerance as MT in RAS/BRAF wild-type mCRC."

Clinical • Metastases • P1/2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF • FLT1

A multi-cohort study of treatment regimens for metastatic colorectal cancer (mCRC): Subgroup analysis of sequential therapy between fruquintinib and regorafenib (AACR 2025) - "Within the mono subgroup, the mOS for the Fru-Reg (mono) group was 19.05 months versus 15.79 months for the Reg-Fru (mono) group.ConclusionThis study provides valuable insights into the comparative effectiveness of sequential Fru and Reg treatment regimens in pts with mCRC. The results showed that in the overall patient population and mono subgroup, pts with Fru sequential Reg had a trend of benefit in mOS compared with pts with Reg sequential Fru opposite, but the difference was not statistically significant, we will continue to increase the sample size of the enrolled pts to further validate this finding."

Metastases • Colorectal Cancer • Oncology • Solid Tumor • CSF1R • FLT1

Efficacy and mechanism of radiotherapy combined with fruquintinib and tirelizumab in mCRC (AACR 2025) - "Combined irradiation on top of fruquintinib and tirelizumab treatment enhanced the efficiency in CT26 murine CRC syngeneic tumor model. There was no significant effect of radiotherapy on the anti-angiogenesis of fruquintinib and the promotion of normal vascular function. Irradiation promoted CD8+ T cell and dendritic cell infiltration and activation."

Clinical • IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • CD31 • CD69 • CD8 • CD86 • PD-L1 • PECAM1

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. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05941325 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P2 data • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

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. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT06010212 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) - P3 | N=430 | Enrolling by invitation | Sponsor: BeiGene | N=300 ➔ 430

Enrollment change • Oncology • Solid Tumor

Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized phase 3 clinical trial in second-line treatment of gastric/gastroesophageal junction adenocarcinoma. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT03223376 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

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. (ASCO 2025) - P=N/A | "Clinical Trial Registration Number: NCT04005066 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • P4 data • Real-world • Real-world evidence • Colorectal Cancer • Oncology • Solid Tumor

Cardiovascular toxicity of fruquintinib in patients with colorectal and other cancers: A systematic review and meta-analysis. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Retrospective data • Review • Cardiovascular • Colorectal Cancer • Oncology

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 2 clinical trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05177068 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Navigating third-line therapies: A comprehensive review of regorafenib versus fruquintinib with placebo comparator for metastatic colorectal cancer—A systematic review and meta-analysis. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Overall survival with fruquintinib versus placebo after adjusting for subsequent anticancer therapy in patients with refractory metastatic colorectal cancer in the FRESCO-2 study. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT04322539 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor

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. (ASCO 2025) - P=N/A | "Clinical Trial Registration Number: NCT04005066 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Monotherapy • P4 data • Real-world • Real-world evidence • Colorectal Cancer • Oncology • Solid Tumor

Real-world observational study of fruquintinib in combination with irinotecan and capecitabine as second-line treatment in patients with advanced colorectal cancer. (ASCO 2025) - P | "Clinical Trial Registration Number: NCT06169202 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Metastases • Observational data • Real-world • Real-world evidence • Colorectal Cancer • Oncology • Solid Tumor

Real-world experience of fruquintinib in patients with metastatic colorectal cancer: A single-center retrospective study in the United States. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: A prospective, single-center phase 2 study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05522738 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor • RAS

Toxicity profile of fruquintinib (Fruq) versus regorafenib (Rego) in refractory metastatic colorectal cancer (mCRC). (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Metastases • Colorectal Cancer • Oncology • Solid Tumor