hemagenleukleucel (Hem101) / National Medical Research Center for Hematology - LARVOL DELTA

Matching-Adjusted Indirect Comparison of Olutasidenib and Ivosidenib in Isocitrate Dehydrogenase 1-Mutated Relapsed/Refractory Acute Myeloid Leukemia. (PubMed, Adv Ther) - "While not confirmatory, these findings may be clinically relevant in the context of this difficult-to-treat R/R IDH1m AML population."

Journal • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • IDH1

A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patients With B-cell Lymphoproliferative Disorders (clinicaltrials.gov) - P1/2 | N=58 | Completed | Sponsor: National Research Center for Hematology, Russia | Recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Nov 2025

IO biomarker • Trial completion • Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CD19 • MYC • TP53

Effectiveness of olutasidenib versus ivosidenib in patients with mutated isocitrate dehydrogenase 1 acute myeloid leukemia who are relapsed or refractory to venetoclax: the 2102-HEM-101 trial versus a US electronic health record-based external control arm. (PubMed, Leuk Lymphoma) - "Following weighting, treatment with OLU versus IVO was associated with significantly higher rates of complete response (RD: 0.25; 95%CI: 0.01, 0.49), transfusion independence (RD: 0.27; 95%CI: 0.01, 0.53), and OS (HR: 0.33; 95%CI: 0.11, 0.94). Results suggest favorable effectiveness of OLU versus IVO in this population."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH1

Effectiveness of Olutasidenib Versus Ivosidenib in Patients with Mutated Isocitrate Dehydrogenase 1 Acute Myeloid Leukemia Who Are Relapsed or Refractory to Venetoclax: The 2102-HEM-101 Trial Versus a US Electronic Health Record-Based External Control Arm (ASH 2024) - "Limited sample sizes in this rare indication may explain the common absence of statistically significant differences. As with any RW-ECA study, limitations include the risk of unmeasured confounding and differential outcome reporting."

Clinical • Acute Myelogenous Leukemia • CNS Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Metabolic Disorders • Oncology • IDH1

Matching-Adjusted Indirect Comparison of Olutasidenib and Ivosidenib in Mutated Isocitrate Dehydrogenase 1-Relapsed/Refractory Acute Myeloid Leukemia (SOHO 2025) - " Analyses used registrational data for olutasidenib (2102-HEM-101; N = 147; individual-level data) and ivosidenib (AG120-C-001; N = 174; study-level data). Naïve and adjusted response rates for olutasidenib vs ivosidenib were comparable (adjusted point estimate favored olutasidenib for CR and ivosidenib for CR/CRh); a longer duration of CR/CRh was observed for olutasidenib. Adjusted OS was similar, although HR favored olutasidenib, and could not be estimated by response category given lack of patient characteristics and reduced ESS. Results rely on the assumption of no unmeasured confounders, which reflects a study methodology limitation."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH1

MATCHING-ADJUSTED INDIRECT COMPARISON (MAIC) OF OLUTASIDENIB (OLU) AND IVOSIDENIB (IVO) IN ISOCITRATE DEHYDROGENASE 1 (IDH1)-MUTATED RELAPSED/REFRACTORY (R/R) ACUTE MYELOID LEUKEMIA (AML) (EHA 2025) - "Given the rarity of IDH1mut R/R AML patients, prospective trials comparing these IDH1 inhibitors are unlikely to be performed.Aims: In the absence of a head-to-head trial, an MAIC was performed to estimate relative treatment effects of OLU vs. IVO in IDH1mut R/R AML.Analyses used registrational data for OLU (Study 2102-HEM-101; N=147; individual-level data) and IVO (AG120-C-001; N=174; study-level data). Naïve and adjusted rates of response for OLU vs. IVO were comparable (adjusted point estimate favored OLU for CR and IVO for CR+CRh), while a longer duration of CR+CRh was observed with OLU. Adjusted OS was similar between the two groups, although the HR favored OLU, and could not be estimated by response category given lack of patient characteristics and reduction in effective sample size (ESS)."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH1

COMPARATIVE EFFECTIVENESS OF OLUTASIDENIB AND IVOSIDENIB IN MIDH1 RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA PATIENTS POST-VENETOCLAX: INSIGHTS FROM 2102-HEM-101 AND A REAL-WORLD EXTERNAL CONTROL (EHA 2025) - "This study suggests OLU has favorable effectiveness versus IVO for patients in mIDH1 AML patients R/R to a VEN-based regimen. As with any RW-ECA study, limitations include the risk of unmeasured confounding and differential outcome reporting."

Clinical • HEOR • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH1

Matching-adjusted indirect comparison (MAIC) of olutasidenib (OLU) and ivosidenib (IVO) in isocitrate dehydrogenase 1 (IDH1)-mutated relapsed/refractory (R/R) acute myeloid leukemia (AML). (ASCO 2025) - " Analyses used registrational data for OLU (Study 2102-HEM-101; N=147; individual-level data) and IVO (AG120-C-001; N=174; study-level data). Naïve and adjusted rates of response for OLU vs. IVO were comparable (adjusted point estimate favored OLU for CR and IVO for CR+CRh), while a longer duration of CR+CRh was observed with OLU. Adjusted OS was similar between the two groups, although the HR favored OLU, and could not be estimated by response category given lack of patient characteristics and reduction in effective sample size (ESS)."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH1