Hansoh Xinfu (flumatinib) / Jiangsu Hengrui Pharma, Jiangsu Hansoh Pharma - LARVOL DELTA

Olverembatinib As Second-Line (2L) Therapy in Patients (pts) with Chronic Phase-Chronic Myeloid Leukemia (CP-CML) (ASH 2024) - P2 | "Twelve (28.6%) pts had received 1L imatinib, and 30 (71.4%) had been treated with a 1L 2G TKI, including dasatinib (n = 5, 11.9%), nilotinib (n = 11, 26.2%), or flumatinib (n = 14, 33.3%). Conclusions This is the first study report of olverembatinib in 2L CP-CML treatment. Olverembatinib may provide an effective and safe 2L treatment option for pts with CP-CML, especially those failing on 1L 2G TKIs."

Clinical • Anemia • Cardiovascular • Chronic Myeloid Leukemia • Hypertension • Neutropenia • Thrombocytopenia • ABL1 • BCR

Efficacy and Long-term Prognosis of Flumatinib in the Treatment of Chronic Myelocytic Leukemia (PubMed, Sichuan Da Xue Xue Bao Yi Xue Ban) - "Compared with imatinib, flumatinib demonstrates superior short-term efficacy and safety profile in the treatment of CML. Despite the lack of significant improvement in long-term OS, flumatinib can still serve as an effective first-line therapeutic option for patients with CML."

Journal • Retrospective data • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Thrombocytopenia

First-Line Flumatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia: A 3-Month Landmark-Evaluable Real-World Experience. (PubMed, Mediterr J Hematol Infect Dis) - No abstract available

Journal • Real-world evidence • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

A PROSPECTIVE STUDY OF FLUMATINIB WITH CHEMOTHERAPY FOR NEWLY DIAGNOSED BCR::ABL1-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA IN ADULTS: RJ-ALL2020.2A TRIAL (EHA 2025) - P=N/A | "In this prospective study, we first reported on the efficacy and safety of flumatinib in the largest adult cohort with newly-diagnosed BCR::ABL1+ ALL. The long-term follow-up data will be updated in the future."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Septic Shock • ABL1 • IKZF1

Matching-adjusted indirect comparison between asciminib and flumatinib as first-line treatment for chronic myeloid leukemia in China. (PubMed, Transl Cancer Res) - P3 | "Imatinib was the common comparator across the ASC4FIRST (NCT04971226) and FESTnd (NCT02204644) trials. Safety analysis showed fewer discontinuations due to AEs at 48 weeks with asciminib (5.5%) than with flumatinib (10.2%), corresponding to a significantly lower risk of discontinuation due AEs (risk ratio: 0.29; 95% CI: 0.10-0.84; P=0.02). A robust statistical model indicated that asciminib provides consistently superior efficacy and safety over flumatinib, supporting its value as a first-line treatment option for patients with CML-CP."

Journal • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Renal Dysfunction in Patients with CML on Long-Term First-Line TKI Therapy: A Single-Center Analysis. (PubMed, Oncologist) - "TKIs exhibit differential renal safety profiles, underscoring the critical importance of individualized TKI selection based on baseline renal status and implementation of rigorous renal monitoring protocols throughout treatment duration."

Journal • Acute Kidney Injury • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Nephrology • Oncology • Renal Disease

Optimizing Flumatinib Therapy in Chinese Chronic-Phase Chronic Myeloid Leukemia Based on Therapeutic Drug Monitoring. (PubMed, Drug Des Devel Ther) - "Flumatinib demonstrates exposure-efficacy-toxicity relationships in Chinese patients with CML-CP. These exploratory findings suggest potential concentration thresholds that may inform future therapeutic drug monitoring strategies, pending prospective validation."

Journal • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

OLVEREMBATINIB AND HIGH-DOSE METHOTREXATE IN ACUTE LYMPHOBLASTIC LEUKEMIA: DELAYED METHOTREXATE CLEARANCE AND INCREASED NEPHROTOXICITY (EHA 2026) - "of patients MTX levels at 48 h > 1 μmol/L [n (%)] MTX levels at 48 h > 5 μmol/L [n (%)] MTX levels at 48 h [μmol/L, average (range)] Clearance [L/h, average (SD)] Nephrotoxicity [n (%)] AKI grade 2-4 Olverembatinib 10 8 (80.00)* 5 (50.00)* 4.99 (0.33-10.32) 5.21 (2.77) 7 (70.00)* 6 (60.00)* Flumatinib 17 10 (58.82) 3 (17.65) 3.44 (0.13-19.44) 6.39 (2.74) 9 (52.94) 5 (29.41) Without TKIs 22 7 (31.82)* 1 (4.55)* 1.32 (0.16-7.74) 8.03 (3.02) 6 (27.27)* 1 (4.55)* P -value (Tri-group comparison) 0.030 0.008 0.018 0.029 0.056 0.002 * * p < 0.05 by Fisher's exact test in pairwise comparison. Summary/Conclusion This study presents a preliminary investigation into the drug-drug interaction between HD-MTX and TKIs, providing valuable insights for treatment optimization. In light of the elevated risk of nephrotoxicity identified, temporarily withholding olverembatinib during the peri-infusion period of HD-MTX is recommended to avoid potentially severe adverse effects."

Acute Kidney Injury • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Nephrology • Renal Disease • ABL1 • BCR

EFFICACY AND SAFETY OF THE FLUMATINIB, VENETOCLAX, VINCRISTINE, AND PREDNISONE (FVVP) REGIMEN IN NEWLY DIAGNOSED ADULT PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (EHA 2026) - "Hematologic adverse events were the main toxicities, with grade 4 neutropenia and thrombocytopenia occurring in 36.4% and 54.5% of patients, respectively—significantly lower than with traditional chemotherapy. . Summary/Conclusion The FVVP regimen represents an effective, safe and cost-effective therapeutic option for Ph+ ALL, warranting further multicenter prospective validation to optimize long-term efficacy."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Central Nervous System Leukemia • Hematological Malignancies • Leukemia • Neutropenia • Thrombocytopenia • ABL1 • BCR • CDKN2A • CDKN2B • IKZF1 • PAX5

EFFICACY AND SAFETY OF FLUMATINIB COMBINED WITH CHEMOTHERAPY IN NEWLY DIAGNOSED ADULT PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (EHA 2026) - "Non-hematologic toxicities included gastrointestinal reactions (31.5% grade 1-2, 68.5% grade 3-4) and transaminase elevation (58.9% grade 1-2, 4% grade 3-4), all manageable with supportive care. . Summary/Conclusion Flumatinib-based combination chemotherapy represents an effective and safe therapeutic option for Ph+ ALL, further multicenter prospective validation for long-term efficacy optimization."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Central Nervous System Leukemia • Neutropenia • Thrombocytopenia • ABL1 • BCR • CDKN2A • CDKN2B • IKZF1 • PAX5

CLINICAL PROFILES AND RISK STRATIFICATION IN ELDERLY PATIENTS WITH NEWLY DIAGNOSED BCR::ABL1-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (EHA 2026) - "All pts received the 2 nd generation TKI, flumatinib (600mg/day), and VP-based (Vincristine/Prednisone) chemotherapy. Figure 1. Survival outcomes and subgroup analysis (low-risk vs. Intermediate/high-risk)"

Clinical • IO biomarker • Acute Lymphocytic Leukemia • Atrial Fibrillation • Bone Marrow Transplantation • CNS Disorders • ABL1 • IKZF1

FLUMATINIB IN CHRONIC MYELOID LEUKEMIA WITH RARE BCR-ABL TRANSCRIPTS: A REPORT OF 4 CASES AND ANALYSIS OF EFFICACY CHARACTERISTICS (EHA 2026) - "The patient was switched to dasatinib and currently has a p230 level of 0.005%. Dual-positive CML (Case 1): Initially treated with imatinib, the patient achieved molecular negativity at 12 months but lost major molecular response (MMR, P210 0.217%) at 31 months, with detection of an M244V mutation. Nilotinib for 3 months re-induced negativity but was switched to flumatinib due to cardiac side effects...The speed and depth of response to flumatinib appear to correlate with the biological characteristics of the specific transcript. Close monitoring and management of flumatinib-associated hepatotoxicity are warranted."

Clinical • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Thrombocytosis • ABL1 • BCR

CURRENT STATUS SURVEY OF TOLERABILITY BURDEN OF FIRST- OR SECOND-LINE TKI THERAPY IN CHINESE PATIENTS WITH CHRONIC MYELOID LEUKEMIA (CML) (EHA 2026) - "Patient characteristics Characteristics N=200 Age [years, median (range)] 43.5(19-76) Age at diagnosis [years, median (range)] 38(10-76) Disease course [years, median (range)] 4.9(0.4-24.3) Gender (%) Male 108(54%) Female 92(46%) Baseline ECOG score (%) 0 95(47%) 1 86(43%) 2 17(9%) 3 1(1%) . 4 0 Current employment status (%) Employed 119(60%) Unemployed 81(40%) TKI treatment duration [months, median (range)] 48.5(3-241) Current line of therapy (%) First line 120(60%) Second line 80(40%) Current generation of TKI (%) 1 st TKI (Imatinib) 70(35%) 2 nd TKI (Nilotinib/Dasatinib/Flumatinib) 125(63%) 3 rd TKI (Olverembatinib/Ponatinib) 5(2%) Comorbidities (%) Diabetes mellitus 16(8%) Hypertension 23(12%) Coronary heart disease 11(6%) Gastrointestinal disorders 18(9%) Liver disease 6(3%) Kidney disease 7(4%) Cerebrovascular disease 5(3%) Pulmonary disease 3(2%) Thrombus 0 None of the above 107(54%)"

Clinical • Cardiovascular • Chronic Myeloid Leukemia • CNS Disorders • Coronary Artery Disease • Diabetes • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Malignancies • Hepatology • Hypertension • Leukemia • Metabolic Disorders • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Thrombosis • Vascular Neurology

ANALYSIS OF THE IMPACT OF TYROSINE KINASE INHIBITORS ON RENAL FUNCTION IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (EHA 2026) - "In the first-line setting, 263 patients were treated with imatinib, 128 with flumatinib, 87 with nilotinib, 21 with dasatinib, and 4 with other TKIs (2 asciminib, 2 radotinib)...In the second-line setting, the most frequently used TKI was dasatinib (n=88), followed by nilotinib (n=11), flumatinib (n=11), and olverembatinib (n=1)...This discrepancy may be attributable to the relatively small sample size of dasatinib-treated patients in the first-line group. . Longitudinal changes in eGFR over time in patients receiving first-line TKI therapies"

Clinical • Chronic Kidney Disease • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Nephrology • Renal Disease

ELN RECOMMENDED RESPONSE MILESTONES PREDICT SURVIVAL AND DEEP MOLECULAR RESPONSE IN CHRONIC PHASE CHRONIC MYELOID LEUKEMIA RECEIVING SECOND-GENERATION TYROSINE KINASE INHIBITOR (EHA 2026) - "The recent studies have focused on the patients treated with imatinib...Methods Patients aged ≥18 years with CML-CP receiving nilotinib, dasatinib or flumatinib as the first-line therapy at Peking University People's Hospital between 2002 and 2025 were retrospectively reviewed...Higher BCR::ABL1 IS at 3 months (ref: >0.1–1%; >10%, HR = 0.3 [0.2, 0.6], P 1–10%, 0.5 [0.4, 0.8], P = 0.002; ≤0.1%, 2.0 (1.4, 2.8], P 0.1–1%; >10%, 0.1 [0.02, 0.4], P = 0.001; >1–10%, 0.5 [0.3, 1.1], P =0.07; ≤0.1%, 3.0 [2.0, 4.5], P 0.1–1%; >1%, 0.3 (0.1, 1.4], P = 0.11; ≤0.1%, 2.6 [1.5, 4.6], P < 0.001) were significantly associated with lower cumulative incidences of DMR. . Summary/Conclusion For patients receiving 2G-TKI, the ELN 3-month treatment milestone is an robust predictor of CML-related OS, whereas the ELN milestones at 3, 6, and 12 months all serve as predictive factors for TFS and DMR."

Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • ABL1

REAL-WORLD ANALYSIS OF FIRST-LINE TKI USE IN CML-CP: A 16-YEAR MULTICENTER EXPERIENCE (EHA 2026) - "Results A total of 3210 patients were enrolled in this study, including 2652 treated with first-line imatinib, 81 with dasatinib, 144 with nilotinib, and 333 with flumatinib. 82570191) and the Zhejiang Provincial Health Highlevel Innovative Talent Project (2022-2026). Correspondence to: Prof Jian Huang, E-mail: [email protected]."

Clinical • Real-world • Real-world evidence • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • ABL1 • BCR

AGE-STRATIFIED ANALYSIS OF CML-CP IN ADOLESCENT AND YOUNG ADULT (AYA) PATIENTS: A MULTICENTER RETROSPECTIVE STUDY (EHA 2026) - "Among second-generation TKIs (dasatinib, nilotinib, and flumatinib), no significant differences were observed in the median time to achieve MMR. . This research was supported by the National Natural Science Foundation of China (No. 82570191) and the Zhejiang Provincial Health Highlevel Innovative Talent Project (2022-2026)."

Retrospective data • Chronic Myeloid Leukemia • Fibrosis • Hematological Malignancies • Immunology • Leukemia • Myeloproliferative Neoplasm • ABL1 • ASXL1 • BCR • CSMD1 • NOTCH2

FRONT-LINE SECOND-GENERATION TKI THERAPY SIGNIFICANTLY IMPROVES THE SUCCESS RATE OF TREATMENT-FREE REMISSION IN CHRONIC MYELOID LEUKEMIA: A MULTICENTER RETROSPECTIVE STUDY OF THE REAL WORLD (EHA 2026) - "Methods In the multicenter, retrospective, real-word study, data on the outcomes of TKI discontinuation in the adults with chronic- phase CML (CML-CP) who had a imatinib therapy duration ≥5 years or a 2G-TKI [nilotinib, dasatinib, or flumatinib] therapy duration ≥3 years and a sustained deep molecular response (DMR) ≥2 years from 17 Chinese hospitals were analyzed. The longer DMR subgroup had higher rates of 5 years sustained MMR than the short DMR subgroup in both imatinib (78% versus 61%, p < 0.001) and 2G- TKI (89% versus 69%, p = 0.038) groups. Summary/Conclusion The real-world multicenter retrospective study revealed that the front-line treatment with a 2G-TKI improved the success rate of TFR in CML-CP patients beyond achieving a longer DMR."

Real-world • Real-world evidence • Retrospective data • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia

THE SAFETY, TOLERABILITY, AND EFFICACY OF HS-10382 COMBINED WITH FLUMATINIB IN PATIENTS WITH NEWLY DIAGNOSED PH+ CML: A PHASE 1B STUDY (EHA 2026) - "Summary/Conclusion HS-10382 in combination with flumatinib demonstrated a manageable safety profile and promising preliminary efficacy in patients with newly diagnosed CML-CP, characterized by rapid achievement and deepening of molecular responses. These findings support continued evaluation in an expanded cohort with longer follow-up to confirm the durability of deep molecular responses and long- term safety."

Clinical • P1 data • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • ABL1

Evaluating comorbidity scoring systems for flumatinib therapy in chronic myeloid leukemia: a machine learning and SHAP-based predictive analysis. (PubMed, Front Med (Lausanne)) - "CIRS-G showed the strongest incremental predictive value among the evaluated comorbidity scores in this single-center cohort. Machine learning and SHAP analysis provide exploratory insights for individualized risk stratification, though the reported predictive performance may overestimate prospective validity due to temporal variations and retrospective design."

Journal • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Mechanistic Physiologically Based Pharmacokinetic Modeling to Predict CYP3A4-Mediated Drug-Drug Interactions of Flumatinib as Both a Victim and a Perpetrator. (PubMed, Drug Des Devel Ther) - "However, when acting as a victim, co-administration with strong CYP3A4 inhibitors (itraconazole, ketoconazole) increased flumatinib AUC0-72h by approximately 12-fold (AUCR = 11.65-12.96), whereas rifampicin decreased Cmax and AUC0-72h by 2.4- and 4.7-fold (CmaxR = 0.41, AUCR = 0.21), respectively. Flumatinib shows negligible perpetrator potential but is highly sensitive to CYP3A4 modulation. PBPK-informed DDI assessment supports cautious co-administration with strong CYP3A4 inhibitors or inducers and guides its rational clinical use."

Journal • PK/PD data • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • CYP3A4

Variables associated with severe cytopenia in adult chronic phase chronic myeloid leukemia patients receiving initial tyrosine kinase inhibitors (PubMed, Zhonghua Xue Ye Xue Za Zhi) - " Data from consecutive patients aged ≥18 years with CML-CP who received imatinib, nilotinib, or flumatinib at Peking University People's Hospital between November 2006 and January 2025 were retrospectively reviewed. High-risk factors for severe cytopenia associated with TKIs included female sex, decreased hemoglobin level, increased white blood cell count, and splenomegaly at initial diagnosis. Close monitoring is necessary during the early phase of TKI-therapy for the high-risk group."

Journal • Retrospective data • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Oncology • Thrombocytopenia

Exploring the potential of vamotinib in Ph+-leukemias: is it a 2nd or 3rd generation tyrosine kinase-inhibitor? (OeGHO-AHOP 2026) - " Sixty-seven different single and compound KD mutations were tested in vitro in Ba/F3 cells expressing either p210 or p190 BCR::ABL1, using eight different TKIs including imatinib, nilotinib, dasatinib, bosutinib, ponatinib, asciminib, flumatinib , and vamotinib. The in vitro resistance profile of vamotinib closely resembles that of the second-generation TKI nilotinib. Interestingly, the recent phase 1 study by Turkina et al. (2025) demonstrated limited yet measurable clinical activity in T315I-positive patients."

Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • ABL1

OLVEREMBATINIB-MEDIATED DEEP REMISSION IMPROVES ALLOGENEIC STEM CELL TRANSPLANTATION OUTCOME IN PATIENTS WITH BLAST CRISIS CHRONIC MYELOID LEUKEMIA: THE FIRST REAL-WORLD PRACTICE (EBMT 2026) - "All patients received TKIs+chemotherapy before transplantation and were stratified by pre-transplant TKIs exposure: 1/2G-TKI cohort (n=43, imatinib, nilotinib, flumatinib or dasatinib) versus olverembatinib (n=26). This real-world analysis provides the first clinical evidence supporting the efficacy and safety of olverembatinib in transplant-eligible BC-CML. Olverembatinib significantly enhances pre-transplant molecular responses, compared to 1/2G-TKIs, associating with improved survival after transplantation. With a manageable safety profile, olverembatinib represents a promising bridging strategy prior to allo-HSCT, potentially redefining frontline management of BC-CML."

Clinical • Real-world • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Transplantation • ABL1 • ASXL1 • IKZF1 • RUNX1

Safety and Efficacy of Flumatinib in Patients with Chronic Phase Chronic Myeloid Leukemia: A Real-Life Cohort Observational Study. (PubMed, Blood Lymphat Cancer) - "Grade 3/4 AEs were infrequent, highlighting flumatinib's manageable safety profile. Flumatinib displays significant clinical efficacy and a superior safety profile compared to other second-generation TKI, whether administered in first-line or subsequent treatment settings."

Journal • Observational data • Chronic Myeloid Leukemia • Fatigue • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Thrombocytopenia