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

Efficacy of Fruquintinib Plus Sintilimab in Special Populations with Advanced Renal Cell Carcinoma: A Subgroup Analysis of FRUSICA-2 Study (ESMO 2026) - No abstract available

Clinical • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Biomarker-Directed Sintilimab Monotherapy/combo in Untreated Advanced NSCLC: A Phase II Umbrella Trial (CTONG1702) (IASLC-WCLC 2026) - "This report presents data from seven cohorts: Sintilimab monotherapy: Cohort 14 (PD-L1 TPS ≥ 50%), Cohort 15 (PD-L1 TPS < 50% with TMB-High), Cohort 16 (PD-L1 TPS < 50% with KRAS/TP53 co-mutations); Sintilimab plus platinum-based chemotherapy: Cohort 17 (PD-L1 TPS < 1% non-squamous cell carcinoma, sintilimab + pemetrexed + cisplatin/carboplatin) and Cohort 18 ( PD-L1 TPS < 1% squamous cell carcinoma, sintilimab + gemcitabine + carboplatin); Sintilimab + fruquintinib: Cohort 22 (PD-L1 TPS < 50%) and Cohort 23 (PD-L1 TPS ≥ 50%). The most common adverse events was proteinuria. Conclusions : TMB-High seems to be a good predictor for long PFS and OS of sintilimab monotherapy; Sintilimab combined with fruquintinib showed prolonged PFS and OS, especially in PD-L1 ≥ 50%, suggesting a novel chemo-free regimen worth exploring."

Biomarker • IO biomarker • Metastases • Monotherapy • P2 data • Tumor mutational burden • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Renal Disease • Solid Tumor • Squamous Cell Carcinoma • KRAS • TMB • TP53

CONCEPT (COmbinatioN of CEtuximab Plus fruquintinib Treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • pMMR • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Fruquintinib plus cadonilimab and S-1 in previously treated unresectable locally advanced or metastatic esophageal squamous cell carcinoma: preliminary efficacy and safety results from a phase Ib/II study (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Health-related quality of life (HRQoL) associated with fruquintinib in the global phase 3, placebo-controlled, double-blind FRESCO-2 study. (ASCO-GI 2023) - P3 | "HRQoL is not negatively impacted by treatment with F. TTD in health utility instrument EQ-5D is improved for patients receiving F. These results, along with improved OS and PFS and favorable toxicity profile, further support F as a potential new treatment option for patients with refractory mCRC. Clinical trial information: NCT04322539."

Clinical • HEOR • P3 data • Colorectal Cancer • Gastrointestinal Cancer

Real-World Outcomes with Fruquintinib in Heavily Pretreated Metastatic Colorectal Cancer: Impact of Patient and Disease Characteristics (ESMO 2026) - No abstract available

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

A Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

New P2 trial • Gastric Cancer • Oncology • Solid Tumor • PD-L1

Updated results from a fruquintinib Expanded Access Program for patients with previously treated metastatic colorectal cancer (ESMO 2026) - No abstract available

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor

FRESCO-2 trial and fruquintinib: A clearer picture of the control arm. (PubMed, Transl Oncol) - "Firstly, we argue that fruquintinib should have been tested against regorafenib, and only offered a moderate benefit despite being tested against a suboptimal placebo. Secondly, fruquintinib is likely cost ineffective (measured in quality-adjusted life years (QALY)), with a crude estimation placing its value over a million USD per QALY. Lastly, we show that the use of a suboptimal placebo is unfortunately not new."

Journal • FLT1

Satellite Symposium 13 (SL13) Recent advances with Fruquintinib in mCRC: Clinical evidence and case-based insights (KSMO 2026) - "Sponsored by Takeda"

Clinical • Colorectal Cancer

Nanoliposomal irinotecan (nal-IRI) combined with fruquintinib as Second-line Treatment For Advanced Gastric Cancer : a Single-arm, Open-label, Dose-escalation and Expansion Phase I/II Trial (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Gastric Cancer • Oncology • Solid Tumor

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

Impact of Fecal Microbiota Transplantation (FMT) on Colorectal Cancer (CRC): A Systematic Review (ACG 2026) - "Clinical trials involving FMT combined with tislelizumab and fruquintinib in refractory microsatellite stable (MSS)showed that there is an improvement in progression-free survival (9.6 months) and OS (13.7 months) compared to metastatic CRC patients. 8 studies were screened for inclusion in our literature review, 7 were preclinical studies and 1 was a clinical study. From preclinical studies, it was shown that FMT derived from healthy donors suppressed CRC progression, reduced tumor burden, and promoted survival by rectifying microbiome imbalance, reducing intestinal inflammation (reductions in IL1α, IL6, and IL12), and inducing antitumor immunity. Clinical studies showed that FMT enriches beneficial bacteria (Bacteroides and Lactobacillus genera) and modulates metabolic pathways."

Review • Colorectal Cancer • Inflammatory Bowel Disease • Oncology • Solid Tumor • Transplantation • IL12A • IL6

A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland (clinicaltrials.gov) - P=N/A | N=110 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Colorectal Cancer • Oncology • Solid Tumor

Fruquintinib: Mechanism of Action, Clinical, and Translational Science. (PubMed, Clin Transl Sci) - P3 | "The most common any-grade treatment-emergent adverse events with fruquintinib (incidence ≥ 20% in either study, excluding laboratory abnormalities) were hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, diarrhea, asthenia, decreased appetite, hypothyroidism, and fatigue. This mini-review summarizes the mechanism of action, pharmacokinetics, key clinical trials, and clinical efficacy and safety data for fruquintinib."

Clinical • Journal • Review • Cardiovascular • Colorectal Cancer • Dermatology • Dysphonia • Endocrine Disorders • Fatigue • Hypertension • Oncology • Renal Disease • Solid Tumor

A phase II, open-label, randomized study of doublet chemotherapy (FOLFOX or FOLFIRI) plus fruquintinib compared with doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab in second line setting for a metastatic colorectal cancer: ULYSSE- FFCD2406 - PRODIGE115 (trials in progress) (ESMO 2026) - No abstract available

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

CHOICE III: Short-Course Preoperative Radiotherapy Followed by Fruquintinib Plus Anti–PD-1 Antibody (Serplulimab) for Neoadjuvant Treatment of pMMR/MSS Mid-to-Low Locally Advanced Rectal Cancer: A Single-Arm, Single-Center, Prospective Phase II Study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Fruquintinib plus eribulin in patients with metastatic HR+, HER2-reast cancer after progression on endocrine therapy plus CDK4/6 inhibitor: Updated results from a phase II study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Oncology • HER-2

A Real-World Study of Low-Dose Fruquintinib Combined with Trifluridine/Tipiracil Hydrochloride (TAS-102) in the Third-Line and Beyond Treatment of Metastatic Colorectal Cancer (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • 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 as third-line therapy in mCRC without targetable mutations, insights from the FRESCO and FRESCO-2 trials: switching mechanism of action in a patient experiencing significant toxicity on chemotherapy. (PubMed, Clin Adv Hematol Oncol) - No abstract available

Journal • Colorectal Cancer

Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study. (ASCO 2026) - P=N/A | "After 6 induction cycles, oxaliplatin was discontinued in both cohorts, and maintenance therapy consisted of S-1/capecitabine plus PD-1 inhibitor, with or without continued fruquintinib... This initial analysis from the biomarker-oriented MGC-FLORA study suggests that the addition of fruquintinib to first-line immunochemotherapy may improve clinical efficacy in advanced G/GEJ adenocarcinoma. Consistent trends toward prolonged PFS were observed in both the overall and propensity score–matched populations, supporting a potential therapeutic benefit of fruquintinib. These findings warrant further validation in randomized trials and integrated biomarker analyses."

Biomarker • Clinical • IO biomarker • Metastases • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology • CLDN18

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

FRESCO-2: A global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer (ESMO 2022) - P3 | "Key criteria: Prior chemotherapy, anti-VEGF therapy, and, if RAS wild type (WT), anti-EGFR therapy; if BRAFV600E mutant (MT) or MSI-H, ≥1 targeted regimen; & prior exposure to trifluridine/tipiracil (T) and/or regorafenib (R). F was well tolerated, with a safety profile consistent with the established profile for F monotherapy. FRESCO-2 results are consistent with FRESCO and should support a new treatment option in refractory mCRC."

Clinical • Late-breaking abstract • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FLT1 • MSI

A Phase II Study of Fruquintinib Combined with Tislelizumab and Sequential Radiotherapy for Recurrent or Oligoprogressive Esophageal Squamous Cell Carcinoma (ASTRO 2026) - "The combination of fruquintinib, tislelizumab, and sequential radiotherapy demonstrated promising efficacy and manageable toxicity in patients with recurrent or oligoprogressive ESCC. A lower PIIV during and after treatment independently predicted longer survival, highlighting its potential as a robust prognostic biomarker and warranting further validation in randomized controlled trials."

IO biomarker • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma