AML-187: The STIMULUS Clinical Trial Program: Evaluating Combination Therapy with MBG453 in Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS) or Acute Myeloid Leukemia

Zeidan, Amer M.; Esteve, Jordi; Kim, Hee-Je; Miyazaki, Yasushi; Platzbecker, Uwe; Schuh, Andre C.; Westermann, Joerg; Malek, Kamel; Scott, Jeffrey W.; Niolat, Julie; Peyrard, Séverine; Kiertsman, Flavia; Stegert, Mario; Fenaux, Pierre

doi:10.1016/s2152-2650(20)30727-8

Cited by 5 publications

(5 citation statements)

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“…The preliminary data from the NCT03066648 trial (MBG453 + HMAs) showed an ORR of 58% in MDS and 38% in newly diagnosed AML patients for the MBG453 + DAC arm and 70% in MDS and 27% in AML patients for the MBG453 + AZA arm, respectively. The most common 3/4 AEs were thrombocytopenia, anemia and neutropenia; in the MBG453 + DAC group, four ir-AEs were reported (ALT increase, arthritis, hepatitis and hypothyroidism), compared to none in the MBG453 + AZA cohort [72,73].…”

Section: The Tim-3/galectin9 Axismentioning

confidence: 95%

Immunotherapy of Acute Myeloid Leukemia: A Work in Progress

Molica,

Perrone,

Rossi

2023

Preprint

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In the last years, molecularly targeted agents and immune based treatments (ITs) have deeply changed the landscape of anti-cancer therapy. Indeed, ITs proved to be very effective in metastatic solid tumors, where outcomes were extremely poor with standard approaches. Such a scenario has been only partially reproduced in hematologic malignancies. In acute myeloid leukemia (AML), as innovative drugs are eagerly awaited in relapsed/refractory setting, different ITs have been explored, but the results are still unsatisfactory. In this work, we will discuss the most important clinical studies to date adopting ITs in AML, providing the bases to understand how this approach, although still in its infancy, may represent a promising therapeutic tool for the next future treatment of AML patients.

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Section: The Tim-3/galectin9 Axismentioning

confidence: 95%

Immunotherapy of Acute Myeloid Leukemia: A Work in Progress

Molica,

Perrone,

Rossi

2023

Preprint

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“…The preliminary data regarding the combination of MBG453 + HMAs (NCT03066648 trial) show ORR values of 58% in MDS and 38% in newly diagnosed AML patients in the MBG453 + DAC arm, and 70% in MDS and 27% in AML patients in the MBG453 + AZA arm, respectively. The most common AEs were thrombocytopenia, anemia and neutropenia; in the MBG453 + DAC group, four ir-AEs were reported (ALT increase, arthritis, hepatitis and hypothyroidism), while none were seen in the MBG453 + AZA cohort [81,82].…”

Section: The Tim-3/galectin9 Signalingmentioning

confidence: 96%

Immunotherapy with Monoclonal Antibodies for Acute Myeloid Leukemia: A Work in Progress

Molica,

Perrone,

Andriola

et al. 2023

Cancers

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In the last few years, molecularly targeted agents and immune-based treatments (ITs) have significantly changed the landscape of anti-cancer therapy. Indeed, ITs have been proven to be very effective when used against metastatic solid tumors, for which outcomes are extremely poor when using standard approaches. Such a scenario has only been partially reproduced in hematologic malignancies. In the context of acute myeloid leukemia (AML), as innovative drugs are eagerly awaited in the relapsed/refractory setting, different ITs have been explored, but the results are still unsatisfactory. In this work, we will discuss the most important clinical studies to date that adopt ITs in AML, providing the basis to understand how this approach, although still in its infancy, may represent a promising therapeutic tool for the future treatment of AML patients.

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“…The interim data from the NCT03066648 trial (MBG453 + HMAs) reported an ORR of 58% in MDS and 38% in newly diagnosed AML patients for the MBG453 + DAC arm and 70% in MDS and 27% in AML patients for the MBG453 + AZA arm, respectively. The commonest grade 3/4 AEs were thrombocytopenia, anemia and neutropenia (febrile or not); in the MBG453 + DAC group, four immune-related events were reported (ALT increase, arthritis, hepatitis and hypothyroidism), compared to none in the MBG453 + AZA cohort [ 156 , 157 ].…”

Section: Checkpoint Inhibitors In Aml Therapymentioning

confidence: 99%

Checkpoint Inhibitors in Acute Myeloid Leukemia

Damiani

Tiribelli

2023

Biomedicines

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The prognosis of acute myeloid leukemia (AML) remains unsatisfactory. Among the reasons for the poor response to therapy and high incidence of relapse, there is tumor cell immune escape, as AML blasts can negatively influence various components of the immune system, mostly weakening T-cells. Since leukemic cells can dysregulate immune checkpoints (ICs), receptor-based signal transductors that lead to the negative regulation of T-cells and, eventually, to immune surveillance escape, the inhibition of ICs is a promising therapeutic strategy and has led to the development of so-called immune checkpoint inhibitors (ICIs). ICIs, in combination with conventional chemotherapy, hypomethylating agents or targeted therapies, are being increasingly tested in cases of AML, but the results reported are often conflicting. Here, we review the main issues concerning the immune system in AML, the main pathways leading to immune escape and the results obtained from clinical trials of ICIs, alone or in combination, in newly diagnosed or relapsed/refractory AML.

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AML-187: The STIMULUS Clinical Trial Program: Evaluating Combination Therapy with MBG453 in Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS) or Acute Myeloid Leukemia

Cited by 5 publications

References 0 publications

Immunotherapy of Acute Myeloid Leukemia: A Work in Progress

Immunotherapy of Acute Myeloid Leukemia: A Work in Progress

Immunotherapy with Monoclonal Antibodies for Acute Myeloid Leukemia: A Work in Progress

Checkpoint Inhibitors in Acute Myeloid Leukemia

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