Momelotinib in Myelofibrosis Patients With Thrombocytopenia:
Post Hoc Analysis From Three Randomized Phase 3 Trials

J 2023

Momelotinib in Myelofibrosis Patients With Thrombocytopenia: Post Hoc Analysis From Three Randomized Phase 3 Trials

KILADJIAN, Jean-Jacques, Alessandro M VANNUCCHI, Aaron T GERDS, Vikas GUPTA, Srdan VERSTOVSEK et. al.

Basic information

Original name

Momelotinib in Myelofibrosis Patients With Thrombocytopenia: Post Hoc Analysis From Three Randomized Phase 3 Trials

Authors

KILADJIAN, Jean-Jacques (guarantor), Alessandro M VANNUCCHI, Aaron T GERDS, Vikas GUPTA, Srdan VERSTOVSEK, Miklos EGYED, Uwe PLATZBECKER, Jiří MAYER (203 Czech Republic, belonging to the institution), Sebastian GROSICKI, Arpad ILLES, Tomasz WOZNY, Stephen T OH, Donal MCLORNAN, Ilya KIRGNER, Sung-Soo YOON, Claire N HARRISON, Barbara KLENCKE, Mei HUANG, Jun KAWASHIMA and Ruben MESA

Edition

HemaSphere, Philadelphia, Lippincott Williams & Wilkins, 2023, 2572-9241

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 6.600 in 2022

RIV identification code

RIV/00216224:14110/23:00132498

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1097/HS9.0000000000000963

UT WoS

001096083700001

Keywords in English

Momelotinib; Myelofibrosis Patients; Thrombocytopenia

Abstract

V originále

The oral activin A receptor type I, Janus kinase 1 (JAK1), and JAK2 inhibitor momelotinib demonstrated symptom, spleen, and anemia benefits in intermediate- and high-risk myelofibrosis (MF). Post hoc analyses herein evaluated the efficacy and safety of momelotinib in patients with MF and thrombocytopenia (platelet counts <100 x 109/L) from randomized phase 3 studies: MOMENTUM (momelotinib versus danazol; JAK inhibitor experienced); SIMPLIFY-1 (momelotinib versus ruxolitinib; JAK inhibitor naive); and SIMPLIFY-2 (momelotinib versus best available therapy; JAK inhibitor experienced); these studies were not statistically powered to assess differences in thrombocytopenic subgroups, and these analyses are descriptive. The treatment effect of momelotinib versus ruxolitinib on week 24 response rates (spleen volume reduction >= 35%/Total Symptom Score reduction >= 50%/transfusion independence) was numerically comparable or better in thrombocytopenic patients versus the overall JAK inhibitor naive population; rates were preserved with momelotinib in thrombocytopenic patients but attenuated with ruxolitinib (momelotinib: 27%/28%/67% overall versus 39%/35%/61% in thrombocytopenic group; ruxolitinib: 29%/42%/49% overall versus 0%/22%/39% in thrombocytopenic group, respectively). In contrast to ruxolitinib, momelotinib maintained high dose intensity throughout the treatment. In the JAK inhibitor experienced population, thrombocytopenic patients had the following: (1) numerically higher symptom and transfusion independence response rates with momelotinib than in control arms; and (2) preserved spleen, symptom, and transfusion independence response rates with momelotinib relative to the overall study populations. The safety profile of momelotinib in thrombocytopenic patients was also consistent with the overall study population. In summary, momelotinib represents a safe and effective treatment option for patients with MF and moderate-to-severe thrombocytopenia.

Citovat

KILADJIAN, Jean-Jacques, Alessandro M VANNUCCHI, Aaron T GERDS, Vikas GUPTA, Srdan VERSTOVSEK, Miklos EGYED, Uwe PLATZBECKER, Jiří MAYER, Sebastian GROSICKI, Arpad ILLES, Tomasz WOZNY, Stephen T OH, Donal MCLORNAN, Ilya KIRGNER, Sung-Soo YOON, Claire N HARRISON, Barbara KLENCKE, Mei HUANG, Jun KAWASHIMA and Ruben MESA. Momelotinib in Myelofibrosis Patients With Thrombocytopenia: Post Hoc Analysis From Three Randomized Phase 3 Trials. HemaSphere. Philadelphia: Lippincott Williams & Wilkins, 2023, vol. 7, No 11, p. 1-15. ISSN 2572-9241. Available from: https://dx.doi.org/10.1097/HS9.0000000000000963.

@article{2348899,
   author = {Kiladjian, JeanandJacques and Vannucchi, Alessandro M and Gerds, Aaron T and Gupta, Vikas and Verstovsek, Srdan and Egyed, Miklos and Platzbecker, Uwe and Mayer, Jiří and Grosicki, Sebastian and Illes, Arpad and Wozny, Tomasz and Oh, Stephen T and McLornan, Donal and Kirgner, Ilya and Yoon, SungandSoo and Harrison, Claire N and Klencke, Barbara and Huang, Mei and Kawashima, Jun and Mesa, Ruben},
   article_location = {Philadelphia},
   article_number = {11},
   doi = {http://dx.doi.org/10.1097/HS9.0000000000000963},
   keywords = {Momelotinib; Myelofibrosis Patients; Thrombocytopenia},
   language = {eng},
   issn = {2572-9241},
   journal = {HemaSphere},
   title = {Momelotinib in Myelofibrosis Patients With Thrombocytopenia: Post Hoc Analysis From Three Randomized Phase 3 Trials},
   url = {https://journals.lww.com/hemasphere/fulltext/2023/11000/momelotinib_in_myelofibrosis_patients_with.6.aspx},
   volume = {7},
   year = {2023}
}

TY  - JOUR
ID  - 2348899
AU  - Kiladjian, Jean-Jacques - Vannucchi, Alessandro M - Gerds, Aaron T - Gupta, Vikas - Verstovsek, Srdan - Egyed, Miklos - Platzbecker, Uwe - Mayer, Jiří - Grosicki, Sebastian - Illes, Arpad - Wozny, Tomasz - Oh, Stephen T - McLornan, Donal - Kirgner, Ilya - Yoon, Sung-Soo - Harrison, Claire N - Klencke, Barbara - Huang, Mei - Kawashima, Jun - Mesa, Ruben
PY  - 2023
TI  - Momelotinib in Myelofibrosis Patients With Thrombocytopenia: Post Hoc Analysis From Three Randomized Phase 3 Trials
JF  - HemaSphere
VL  - 7
IS  - 11
SP  - 1-15
EP  - 1-15
PB  - Lippincott Williams & Wilkins
SN  - 25729241
KW  - Momelotinib
KW  - Myelofibrosis Patients
KW  - Thrombocytopenia
UR  - https://journals.lww.com/hemasphere/fulltext/2023/11000/momelotinib_in_myelofibrosis_patients_with.6.aspx
N2  - The oral activin A receptor type I, Janus kinase 1 (JAK1), and JAK2 inhibitor momelotinib demonstrated symptom, spleen, and anemia benefits in intermediate- and high-risk myelofibrosis (MF). Post hoc analyses herein evaluated the efficacy and safety of momelotinib in patients with MF and thrombocytopenia (platelet counts <100 x 109/L) from randomized phase 3 studies: MOMENTUM (momelotinib versus danazol; JAK inhibitor experienced); SIMPLIFY-1 (momelotinib versus ruxolitinib; JAK inhibitor naive); and SIMPLIFY-2 (momelotinib versus best available therapy; JAK inhibitor experienced); these studies were not statistically powered to assess differences in thrombocytopenic subgroups, and these analyses are descriptive. The treatment effect of momelotinib versus ruxolitinib on week 24 response rates (spleen volume reduction >= 35%/Total Symptom Score reduction >= 50%/transfusion independence) was numerically comparable or better in thrombocytopenic patients versus the overall JAK inhibitor naive population; rates were preserved with momelotinib in thrombocytopenic patients but attenuated with ruxolitinib (momelotinib: 27%/28%/67% overall versus 39%/35%/61% in thrombocytopenic group; ruxolitinib: 29%/42%/49% overall versus 0%/22%/39% in thrombocytopenic group, respectively). In contrast to ruxolitinib, momelotinib maintained high dose intensity throughout the treatment. In the JAK inhibitor experienced population, thrombocytopenic patients had the following: (1) numerically higher symptom and transfusion independence response rates with momelotinib than in control arms; and (2) preserved spleen, symptom, and transfusion independence response rates with momelotinib relative to the overall study populations. The safety profile of momelotinib in thrombocytopenic patients was also consistent with the overall study population. In summary, momelotinib represents a safe and effective treatment option for patients with MF and moderate-to-severe thrombocytopenia.
ER  -

KILADJIAN, Jean-Jacques, Alessandro M VANNUCCHI, Aaron T GERDS, Vikas GUPTA, Srdan VERSTOVSEK, Miklos EGYED, Uwe PLATZBECKER, Jiří MAYER, Sebastian GROSICKI, Arpad ILLES, Tomasz WOZNY, Stephen T OH, Donal MCLORNAN, Ilya KIRGNER, Sung-Soo YOON, Claire N HARRISON, Barbara KLENCKE, Mei HUANG, Jun KAWASHIMA and Ruben MESA. Momelotinib in Myelofibrosis Patients With Thrombocytopenia: Post Hoc Analysis From Three Randomized Phase 3 Trials. \textit{HemaSphere}. Philadelphia: Lippincott Williams \&{} Wilkins, 2023, vol.~7, No~11, p.~1-15. ISSN~2572-9241. Available from: https://dx.doi.org/10.1097/HS9.0000000000000963.

Detailed Information on Publication Record