NMS-088 / Nerviano Medical Sciences - LARVOL DELTA

Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Nerviano Medical Sciences | N=140 ➔ 200 | Trial completion date: Sep 2023 ➔ Feb 2026 | Trial primary completion date: Sep 2023 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

NMS-088, which inhibits FLT3, KIT, and CSF1, may be useful for FLT3 mutation-positive relapsed/refractory AML treated with FLT3 inhibitor [AACR 2023] [Google translation] (Nikkei) - P1/2 | N=140 | NCT03922100 | "NMS-088 demonstrated manageable safety and no MTD was identified. Patients receiving 360 mg on schedule A experienced 3 DLTs with grade 3 or greater postural abnormalities, hypoactivity, and dyspnea....Anti-tumor effects were observed only in FLT3 mutation-positive patients. Twenty-one patients with FLT3-mutant AML were evaluable for antitumor efficacy and received doses of 120 mg to 360 mg on Schedule A or B. Patients receiving doses greater than 180 mg responded as assessed by the study group, with 3 CRi and 2 MLFS (morphologic leukemic cell-free state)....Long-term (>7 cycles) stable disease was also achieved in three of the patients who received doses of 180 mg or less."

P1/2 data • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

NMS-03592088, a novel, potent FLT3, KIT and CSF1R inhibitor with activity in FLT3 positive acute myeloid leukemia patients with prior FLT3 inhibitor experience (AACR 2023) - "Despite the approval of midostaurin and gilteritinib, the prognosis for FLT3+ patients with relapsed or refractory disease is poor. NMS-088 showed clinical efficacy in pts with FLT3+ R/R AML, including pts who have failed prior FLT3 inhibitors. Together with the manageable safety observed, these results warrant further development of this drug including potential as a novel valuable therapeutic option for pts who have exhausted available treatments. The trial is currently opened for enrollment (NTC03922100)."

Clinical • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

"FLT3、KIT、CSF1を阻害する #NMS088 が、FLT3阻害薬の投与歴がある #FLT3変異 陽性の再発・難治性 #急性骨髄性白血病（#AML）に有用である可能性が明らかとなりました。 #AACR23 https://t.co/OVLDIm1tgO" (@cancer_navi)

Acute Myelogenous Leukemia • Oncology • CSF1

Study of first administration in humans and efficacy of NMS-03592088, an inhibitor of FLT3, KIT and CSF1R, in patients with Relapsing or Drug-resistant Acute Myeloid Leukemia (LMA) and Chronic Myelomonocytic Leukemia (LMMC). Studio di prima somministrazione nell'uomo e di efficacia di NMS-03592088, un inibitore di FLT3, KIT e CSF1R, in pazienti con Leucemia Mieloide Acuta (LMA) e Leucemia... (clinicaltrialsregister.eu) - P1/2; N=165; Ongoing; Sponsor: NERVIANO MEDICAL SCIENCES SRL

Clinical • New P1/2 trial • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML (clinicaltrials.gov) - P1/2; N=140; Recruiting; Sponsor: Nerviano Medical Sciences

Clinical • New P1/2 trial • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • FLT3

A Phase I/II Study of NMS-03592088, a FLT3, KIT and CSF1R Inhibitor, in Patients with Relapsed or Refractory AML or CMML (ASH 2019) - "In a FLT3-ITD model of disseminated AML, efficacy observed following single agent treatment with NMS-03592088 was further significantly increased when administered in combination with cytarabine, with excellent tolerability. Exploratory endpoints are included to evaluate the potential effects of treatment with NMS-03592088 on circulating levels of CSF1 in plasma, the potential correlation of cellular CSF1R expression levels with clinical outcome in both AML and CMML, and the mutational status of a panel of leukemia-related genes, not limited to FLT3. The Phase I part started in Italy in March, 2019 and is currently ongoing."

Clinical • P1/2 data • CSF1R • FLT3