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Therapy Name	Momelotinib
Synonyms
Therapy Description	Momelotinib (CYT387) is an ATP-competitive and selective inhibitor of JAK1 and JAK2, which inhibits cell proliferation and promotes apoptosis (PMID: 19295546, PMID: 31733040, PMID: 32394008).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Momelotinib		CYT387\|CYT-387\|GS-0387	JAK1 Inhibitor - ATP competitive 5 JAK2 Inhibitor - ATP competitive 15	Momelotinib (CYT387) is an ATP-competitive and selective inhibitor of JAK1 and JAK2, which inhibits cell proliferation and promotes apoptosis (PMID: 19295546, PMID: 31733040, PMID: 32394008).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FLT3 exon 14 ins	acute myeloid leukemia	sensitive	Momelotinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Momelotinib (CYT387) inhibited proliferation of acute myeloid leukemia cell lines and patient-derived cells harboring FLT3-ITD mutations in culture, and resulted in prolonged survival and reduced leukemic burden in cell line xenograft models (PMID: 34768286).	34768286
CSF3R S783fs	chronic neutrophilic leukemia	predicted - resistant	Momelotinib	Preclinical - Patient cell culture	Actionable	In a preclinical study, cells derived from a patient with chronic neutrophilic leukemia harboring CSF3R S783fs did not respond to treatment with Momelotinib (CYT387) in culture (PMID: 23656643).	23656643
JAK3 V718L	esophagus adenocarcinoma	sensitive	Momelotinib	Preclinical - Patient cell culture	Actionable	In a preclinical study, Momelotinib (CYT387) inhibited viability of cells derived from the brain metastases of a patient with esophagus adenocarcinoma harboring JAK3 V718L in culture (PMID: 38985431).	38985431
FLT3 exon 14 ins	hematologic cancer	sensitive	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, Momelotinib (CYT387) decreased phosphorylation of Flt3 and Stat5 and inhibited proliferation of transformed cells expressing a FLT3-ITD mutation in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 D835Y	hematologic cancer	sensitive	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, Momelotinib (CYT387) decreased phosphorylation of Flt3 and Stat5 and inhibited proliferation of transformed cells expressing FLT3-ITD and FLT3 D835Y in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 D839G	hematologic cancer	sensitive	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, Momelotinib (CYT387) decreased phosphorylation of Flt3 and Stat5 and inhibited proliferation of transformed cells expressing FLT3-ITD and FLT3 D839G in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 F691L	hematologic cancer	resistant	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 F691L demonstrated resistance to Momelotinib (CYT387) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 F691L FLT3 D835Y	hematologic cancer	resistant	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD with FLT3 F691L and D835Y demonstrated resistance to Momelotinib (CYT387) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 Y842H	hematologic cancer	sensitive	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, Momelotinib (CYT387) decreased phosphorylation of Flt3 and Stat5 and inhibited proliferation of transformed cells expressing FLT3-ITD and FLT3 Y842H in culture (PMID: 34768286).	34768286
JAK2 L583_A586delinsS	hematologic cancer	resistant	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing JAK2 L583_A586delinsS demonstrated resistance to inhibition of cell proliferation by Momelotinib (CYT387) in culture (PMID: 31697804).	31697804
JAK2 V617F	hematologic cancer	sensitive	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, Momelotinib (CYT387) inhibited proliferation of transformed cells expressing JAK2 V617F in culture (PMID: 34768286).	34768286
JAK2 V617F JAK2 E985K	hematologic cancer	resistant	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, cells expressing the JAK2 V617F and JAK2 E985K double mutation demonstrated resistance to Momelotinib in culture (PMID: 21926964).	21926964
JAK2 V617F JAK2 G935R	hematologic cancer	resistant	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, cells expressing the JAK2 V617F and JAK2 G935R double mutation demonstrated resistance to Momelotinib in culture (PMID: 21926964).	21926964
JAK2 V617F JAK2 M929I	hematologic cancer	predicted - sensitive	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, cells expressing the JAK2 V617F and JAK2 M929I double mutation were sensitive to treatment with Momelotinib in culture, demonstrating growth inhibition (PMID: 21926964).	21926964
JAK2 V617F JAK2 Y931C	hematologic cancer	resistant	Momelotinib	Preclinical - Cell culture	Actionable	In a preclinical study, cells expressing the JAK2 V617F and JAK2 Y931C double mutation demonstrated resistance to Momelotinib in culture (PMID: 21926964).	21926964
JAK2 R867Q	hematologic cancer	decreased response	Momelotinib	Preclinical	Actionable	In a preclinical study, immune cells expressing JAK2 R867Q demonstrated decreased response to Momelotinib (CYT387) in culture (PMID: 24398328).	24398328
JAK2 V617F JAK2 I960V	hematologic cancer	resistant	Momelotinib	Preclinical	Actionable	In a preclinical study, immune cells expressing the JAK2 V617F and JAK2 I960V double mutation demonstrated resistance to Momelotinib in culture (PMID: 21926964).	21926964
JAK2 V617F JAK2 R938L	hematologic cancer	resistant	Momelotinib	Preclinical	Actionable	In a preclinical study, immune cells expressing the JAK2 V617F and JAK2 R938L double mutation demonstrated resistance to Momelotinib (CYT387) in culture (PMID: 21926964).	21926964

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02251821	Phase II	Fludarabine Tacrolimus Mycophenolate mofetil Busulfan Pacritinib Momelotinib Melphalan Methotrexate Ruxolitinib Cyclophosphamide	JAK-2 Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis	Active, not recruiting	USA	0
NCT03441113	Phase II	Momelotinib	Extended Access of Momelotinib in Adults With Myelofibrosis	Active, not recruiting	USA \| ROU \| POL \| NLD \| ITA \| ISR \| HUN \| GBR \| FRA \| ESP \| DNK \| DEU \| CAN \| BGR \| BEL \| AUT \| AUS	3
NCT04173494	Phase III	Danazol Momelotinib	A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Patients (MOMENTUM)	Completed	USA \| SWE \| ROU \| POL \| NZL \| ITA \| ISR \| HUN \| GBR \| FRA \| ESP \| DNK \| DEU \| CZE \| CAN \| BGR \| BEL \| AUT \| AUS	3
NCT02101021	Phase II	Gemcitabine + Nab-paclitaxel Momelotinib	Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma	Terminated	USA	0
NCT02244489	Phase I	Capecitabine Oxaliplatin Momelotinib	Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma	Terminated	USA	0
NCT02258607	Phase I	Momelotinib Momelotinib + Trametinib	Efficacy and Safety of Momelotinib and Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase	Terminated	USA	0

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