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

Real-World Comparison of Later-Line Therapies in Metastatic Colorectal Cancer (HOPA 2026) - "Once a patient has progressed through all conventional treatment regimens including a fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab, and cetuximab (or panitumumab), three treatment regimens have become available as last-line therapy options. The primary objective is to assess differences in overall survival (OS) between regorafenib or fruquintinib when administered after FTD-TPI based therapy in heavily pretreated patients with metastatic colorectal cancer. Results; In Process"

Clinical • Metastases • Real-world • Real-world evidence • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Tolerability of Subsequent Line therapy in Metastatic Colorectal Cancer after Fluoropyrimidine-Based Regimens (HOPA 2026) - "Patients that have progressed on all fluoropyrimidine-based regimens, including oxaliplatin and irinotecan, or other biomarker-directed therapies have three options for subsequent-line therapy: regorafenib, fruquintinib, and trifluridine/tipiracil +/- bevacizumab...Conclusion/ Data collection is currently ongoing. Once collected and analyzed using descriptive and inferential statistics, the results of this study will be presented at the 2026 HOPA Annual Conference."

IO biomarker • Metastases • Colorectal Cancer • Oncology • Solid Tumor

Ph1b evaluation of ADG126 (muzastotug, an anti-CTLA-4 masking antibody) pembrolizumab (Pembro) IO doublet in combination with fruquintinib (Fruq) in advanced and metastatic microsatellite stable colorectal cancer (AACR 2026) - "Abstract is embargoed at this time."

Combination therapy • Metastases • Colorectal Cancer • Oncology • Solid Tumor

Rewiring the immune-excluded tumor microenvironment: Vactosertib/anti-PD-1/VEGF inhibitor triplet therapy reinstates antitumor immunity in CRC (AACR 2026) - "BALB/c mice bearing tumors were treated with the FDA-approved pan-VEGFR inhibitor fruquintinib (Fru), an anti-PD-1 antibody, and/or Vac. Triple blockade using Vac, an anti-PD-1 inhibitor, and a VEGFR inhibitor achieved superior antitumor efficacy and broad immune activation compared to all other dual combination therapies in PD-1-resistant CRC. These results suggest that TGF-β inhibition is essential for overcoming treatment resistance in an immunosuppressive TME, supporting the clinical evaluation of this triple combination in refractory CRC."

Biomarker • Tumor microenvironment • Colorectal Cancer • Oncology • Solid Tumor • CD4 • CD8 • IFNG • TGFB1

A first in human, dose escalation (DE) and biomarker cohort expansion (BCE) of IMT-009 (IMT) in advanced cancer and Phase 1b (Ph1b) combination with fruquintinib (F) in microsatellite stable colorectal cancer (MSS CRC) (AACR 2026) - "Abstract is embargoed at this time."

Biomarker • First-in-human • Metastases • P1 data • Colorectal Cancer • Oncology • Solid Tumor

BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) - P3 | N=404 | Active, not recruiting | Sponsor: BeOne Medicines | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs (clinicaltrials.gov) - P3 | N=142 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

New P3 trial • Colorectal Cancer • Oncology • Solid Tumor • HER-2

A predictive model for treatment efficacy in RAS wild-type advanced colorectal cancer: development and external validation for EGFR inhibitor plus anti-angiogenic therapy based on a retrospective cohort. (PubMed, Sci Rep) - "This retrospective multi-center study included 600 RAS wild-type advanced CRC patients (development cohort: 420 patients from two centers; external validation cohort: 180 patients from an independent center) treated with EGFR inhibitors (cetuximab/panitumumab) plus anti-angiogenic agents (bevacizumab/fruquintinib/regorafenib) between 2018 and 2021. As a supplementary tool to current clinical guidelines, the model can partially address the problem of clinical response heterogeneity in combination therapy and provide simple decision support for clinicians in primary and secondary hospitals with limited detection conditions. However, the model has certain limitations in long-term prognostic prediction and needs to be further optimized and validated in larger, multi-center prospective cohorts before it can be translated into clinical practice of precision oncology."

Journal • Retrospective data • Tumor mutational burden • Colorectal Cancer • Oncology • Solid Tumor • CEACAM5 • TMB

Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): Results from phase III part of a randomized, open-label, active-controlled phase II/III study (FRUSICA-2) (ESMO 2025) - P2/3 | "The incidences of grade ≥3 TEAEs (71.4% vs 58.8%), TEAEs leading to treatment discontinuation (17.6% vs 9.6%), and fatal TEAEs (4.2% vs 4.4%) were comparable between groups. Table: 2592MO Efficacy Results by IMDC Prognostic Risk ITT set (BIRC-assessed) IMDC risk factor Number of IMDC risk factor Favorable-risk Intermediate-risk Poor-risk 0-1 risk factors FRUQ+ SIN N=33 AXI/EVE N=32 FRUQ+ SIN N=73 AXI/EVE N=72 FRUQ+ SIN N=13 AXI/EVE N=11 FRUQ+ SIN N=76 AXI/EVE N=73 mPFS, months NR 8.31 22.21 6.97 9.69 4.21 24.87 8.31 Unstratified HR (95% CI) 0.270 (0.117, 0.620) 0.352 (0.221, 0.562) 0.591 (0.203, 1.721) 0.278 (0.168, 0.461) Unstratified log-rank p * 0.0009 <0.0001 0.3267 <0.0001 ORR (%) 63.6 25.0 61.6 23.6 46.2 27.3 63.2 26.0 Odds ratio (95% CI) 5.250 (1.608, 17.712) 5.200 (2.394, 11.435) 2.286 (0.315, 19.098) 4.872 (2.292, 10.456) p * 0.0019 <0.0001 0.3514 <0.0001 *Two-sided Conclusions FRUQ+SIN demonstrated superior mPFS and manageable safety compared..."

Clinical • Metastases • Monotherapy • P2/3 data • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Fruquintinib plus tislelizumab in microsatellite stable metastatic colorectal cancer: Results from a phase Ib/II study (ESMO 2025) - P1/2 | "Methods Adults with MSS mCRC who had progressed on or had intolerance to ≥2 lines of chemotherapy (including fluorouracil, oxaliplatin, and irinotecan) and previous VEGF/EGFR inhibitors as indicated, were enrolled. Conclusions Fruquintinib + tislelizumab showed efficacy and tolerability in pts with previously treated mCRC; efficacy outcomes were more favorable in pts without liver mets at BL, with a notable improvement in median PFS. Safety data were consistent with known profiles of both treatments."

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

Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): Results from phase II part of FRUSICA-2 (ESMO Asia 2025) - P2/3 | "Background: FRUSICA-2 is a randomized, open-label, active-controlled phase 2/3 study (NCT05522231) designed to evaluate the efficacy and safety of Fruquintinib (F) + Sintilimab versus Axitinib or Everolimus monotherapy for 2L treatment of RCC. Results from this F monotherapy of the FRUSICA-2 indicated a comparable anti-tumor efficacy compared with other 2L VEGFR-TKI monotherapies, along with a manageable safety profile in 2L RCC pts after first-line VEGFR-TKI therapy."

Clinical • Metastases • Monotherapy • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Fruquintinib plus serplulimab as first-line therapy in metastatic or unresectable non-clear cell renal cell carcinoma (nccRCC): Updated efficacy and safety data from a multicenter, single-arm, phase II trial. (ASCO-GU 2026) - P2 | "The combination of fruquintinib and serplulimab showed promising anti-tumor activity with acceptable tolerability as first-line treatment for metastatic or unresectable nccRCC. This novel combination therapy has the potential to become a valuable therapeutic option for this challenging disease."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Solid Tumor • FH • TFE3

Expert opinion on treatment patterns in metastatic colorectal cancer management in Eastern Europe. (PubMed, BMC Proc) - "They also noted the need for generating real-world evidence on the safety and efficacy of fruquintinib, its comparative efficacy versus other later-line therapies, its efficacy as an earlier line of therapy, and its sequencing in the current treatment practices. Furthermore, despite the lack of direct experience with fruquintinib, most experts acknowledged its potential efficacy as a later-line therapy for mCRC and considered its effectiveness to be comparable to that of other third-line treatments."

Journal • Colorectal Cancer • Oncology • Solid Tumor

Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study (clinicaltrials.gov) - P1/2 | N=106 | Active, not recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

Checkpoint inhibition • New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor • MLH1 • MSH2 • MSH6 • MSI

Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Sun Yat-sen University

IO biomarker • New P2 trial • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Fruquintinib in combination with tislelizumab versus trifluridine/tipiracil and bevacizumab in third-line and beyond MSS mCRC without active liver metastases-the IKF-080/AIO-QUINTIS trial. (PubMed, ESMO Gastrointest Oncol) - "Patients with metastatic colorectal cancer (mCRC) who have progressed on fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic agents, and anti-epidermal growth factor receptor (EGFR) therapies have limited treatment options and poor prognosis, with a median overall survival (mOS) of ∼6 months on single-agent regorafenib or trifluridine/tipiracil. Tumor assessments occur every 8 weeks; follow-up continues for up to 18 months after enrolment. Optional translational research includes tumor, blood, and stool sampling to explore biomarkers of response and resistance."

IO biomarker • Journal • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Safety and tolerability of fruquintinib: Pooled analysis of three placebo-controlled studies in patients with metastatic colorectal cancer (ESMO 2025) - P2, P3 | "FRESCO-2 pts had prior standard chemo, anti-VEGF and anti-EGFR tx if indicated, and TAS-102 and/or regorafenib. Most pts were able to maintain the 5 mg starting dose, and discontinuation rates due to AESIs were low. These data support fruquintinib as an effective, tolerable tx in pretreated pts with mCRC."

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

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: BeOne Medicines | Trial completion date: Dec 2026 ➔ Jul 2026 | Trial primary completion date: Dec 2026 ➔ Jul 2026

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

ASCO GU 2026: Fruquintinib + Serplulimab as First Line Therapy in Metastatic or Unresectable Non-Clear Cell RCC: Updated Efficacy and Safety Data from a Multicenter, Single-Arm, Phase II Trial (UroToday) - "With a median follow-up of 10 months (95% CI: 9.2–15.9) for progression free survival, the median progression free survival was not reached, and the 9-month progression free survival rate was 87.3%. Among the 36 efficacy evaluable patients, 1 achieved complete response, 18 achieved partial response, and 16 had stable disease, yielding an objective response rate of 52.8% (95% CI 36.5–69.1) and a disease control rate of 97.2% (95% CI 85.5–99.9)."

P2 data • Renal Cell Carcinoma

Explore the efficacy of microwave ablation combined with fruquintinib and tislelizumab in the treatment of metastatic colorectal cancer. (PubMed, Front Oncol) - P0 | "It is anticipated that these findings will expand therapeutic options available to patients. https://www.chictr.org.cn/showproj.html?proj=140822, identifier ChiCTR 2200058323 (China Clinical Trial Center)."

Journal • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • CEACAM5

Possible Fruquintinib Associated Ischemic Colitis in a Patient with Metastatic Ampullary Adenocarcinoma. (PubMed, Eur J Case Rep Intern Med) - "Vascular endothelial growth factor receptor tyrosine kinase inhibitors, including fruquintinib, may predispose to ischemic colitis through microvascular dysfunction, even in the absence of large-vessel occlusion or traditional ischemic risk factors.Ischemic colitis should be considered in patients receiving or recently exposed to anti-angiogenic therapies who present with acute haematochezia and segmental colitis, despite delayed symptom onset after drug discontinuation.Early recognition, exclusion of alternative aetiologies, and prompt withdrawal of the suspected agent with supportive management can lead to favourable outcomes and may prevent progression to perforation or surgical intervention."

Journal • Ampulla of Vater Adenocarcinoma • Ampulla of Vater Carcinoma • Gastroenterology • Gastrointestinal Disorder • Immunology • Oncology

Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerability, and Efficacy. (clinicaltrials.gov) - P2 | N=76 | Not yet recruiting | Sponsor: Tao Zhang

New P2 trial • pMMR • Colorectal Cancer • Oncology • Solid Tumor

EMB-01, a tetravalent anti-EGFR/cMET bispecific antibody, in the left-sided, RAS/BRAF wild-type, late-line metastatic colorectal cancer: Subgroup analysis of baseline characteristics and response from a phase 1/2 study. (ASCO-GI 2026) - P1/2 | " In this exploratory baseline characteristics/response subgroup analysis, all patients with left-sided, RAS/BRAF wild-type mCRC and no prior fruquintinib/regorafenib/TAS-102 (favorable group) were selected from a Phase 1/2 study (NCT05176665). EMB-01 demonstrated a promising efficacy signal in left-sided, RAS/BRAF wild-type mCRC patients naive to 3rd line SOC. In addition to typical prognostic factors, such as younger age, fewer metastatic sites and shorter intervals from initial or metastatic diagnosis, fewer baseline genomic alterations via ctDNA may be a novel positive indicator for EMB-01 efficacy, while liver/lung metastases appear less impactful as adverse prognostic factors. In summary, these findings warrant further evaluation of EMB-01 in late-line mCRC."

Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • RAS

RAPID AI-ENABLED PICO SCOPING TO SUPPORT EUROPEAN JOINT CLINICAL ASSESSMENTS: A 4TH-LINE METASTATIC COLORECTAL CANCER CASE STUDY (ISPOR 2026) - "Explicit and implicit PICO elements were extracted, including population definitions, interventions, comparators, outcomes, and subgroup specifications, and organized into a consolidated JCA-aligned PICO framework. Across HTA bodies, the 4th-line mCRC population was consistently defined as adults with metastatic disease who progressed after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, typically with ECOG performance status 0-1. Interventions commonly assessed included regorafenib, trifluridine/tipiracil (with or without bevacizumab), and fruquintinib... ValueGen.AI enabled rapid consolidation of national PICO specifications into a single, structured, JCA-aligned framework, supporting cross-country scoping while preserving flexibility for national decision-making and limiting additive PICO expansion. The scoping process, which traditionally requires weeks of expert review, was completed within hours with full traceability to source HTA documents."

Case study • Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor

Dr Lieu on Mapping Third-Line Treatment Strategy in mCRC (OncLive) - "Lieu explained that selecting between these agents is largely informed by the patient’s prior toxicity profile. If a patient has significant bone marrow issues or cytopenias resulting from previous chemotherapy, adding another cytotoxic agent may be inappropriate. Conversely, for patients with cardiovascular concerns such as hypertension, oncologists may steer away from drugs like fruquintinib - which can exacerbate high blood pressure—in favor of an agent with a different adverse effect profile. Ultimately, Lieu concluded that third-line selection is a balance of efficacy and the preservation of quality of life."

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