Therapy Detail

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Olverembatinib		HQP 1351\|HQP-1351\|GZD824 dimesylate\|GZD824\|HQP1351	ABL1 Inhibitor 8 FGFR1 Inhibitor 28 FLT3 Inhibitor 69 KIT Inhibitor 57 PDGFR-alpha Inhibitor 10	Olverembatinib (HQP1351) is a third-generation BCR-ABL inhibitor and multikinase inhibitor that inhibits KIT, ABL1, FGFR1, FLT3, and PDGFRA (PMID: 32247263), which potentially induces apoptosis, and inhibits tumor cell growth, migration, and invasion (PMID: 31673329).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FGFR1 V561F	Advanced Solid Tumor	sensitive	Olverembatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Olverembatinib (HQP1351) treatment inhibited cell growth, Fgfr1 phosphorylation, and downstream pathway activation and induced cell cycle arrest and apoptosis in cells expressing FGFR1 V561F in culture and inhibited tumor growth in cell line xenograft models, with a tumor growth inhibition of 73.4% (PMID: 34114373).	34114373
FGFR1 V561M	Advanced Solid Tumor	sensitive	Olverembatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Olverembatinib (HQP1351) treatment inhibited cell growth and Fgfr1 phosphorylation and downstream pathway activation in cells expressing FGFR1 V561M in culture and inhibited tumor growth in cell line xenograft models, with a tumor growth inhibition of 49.8% (PMID: 34114373).	34114373
FLT3 exon 14 ins	acute myeloid leukemia	sensitive	Olverembatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Olverembatinib (HQP1351) reduced Flt3 and Stat5 phosphorylation, induced cell cycle arrest and apoptosis, and inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD in culture, and suppressed tumor growth, decreased Flt3 activation, and induced apoptosis in cell line xenograft models (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 F691I	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Olverembatinib (HQP1351) reduced Flt3 and Stat5 phosphorylation and inhibited growth of transformed cells expressing FLT3-ITD and FLT3 F691I in culture, and suppressed tumor growth, decreased Flt3 activation, and induced apoptosis in cell line xenograft models (PMID: 32247263).	32247263
KIT V560_L576del KIT V654A	gastrointestinal stromal tumor	sensitive	Olverembatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Olverembatinib (HQP1351) treatment inhibited Kit downstream signalling, resulted in cell cycle arrest and apoptosis in a Gleevec (imatinib)-resistant gastrointestinal stromal tumor (GIST) cell line harboring KIT V560_L576del and V654A in culture, and inhibited tumor growth in a cell line xenograft model (PMID: 31673329).	31673329
KIT V560_Y578del	gastrointestinal stromal tumor	sensitive	Olverembatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Olverembatinib (HQP1351) treatment inhibited Kit activity and proliferation of a gastrointestinal stromal tumor (GIST) cell line harboring KIT V560_Y578del in culture, and inhibited tumor growth in a cell line xenograft model (PMID: 31673329).	31673329
FLT3 exon 14 ins FLT3 E654D	acute myeloid leukemia	predicted - sensitive	Olverembatinib	Preclinical - Patient cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) reduced Flt3 and Stat5 activation and inhibited growth of patient-derived acute myeloid leukemia cells harboring FLT3-ITD and FLT3 E654D in culture (PMID: 32247263).	32247263
FGFR1 amp	Advanced Solid Tumor	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) treatment inhibited cell growth, Fgfr1 phosphorylation, and downstream pathway signaling in cell lines with FGFR1 amplification in culture (PMID: 34114373).	34114373
FGFR1 K656E	Advanced Solid Tumor	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of a cell line expressing FGFR1 K656E in culture (PMID: 34114373).	34114373
FGFR1 K656N	Advanced Solid Tumor	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of a cell line expressing FGFR1 K656N in culture (PMID: 34114373).	34114373
FGFR2 amp	Advanced Solid Tumor	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of FGFR2 amplified cell lines in culture (PMID: 34114373).	34114373
FLT3 D835H	hematologic cancer	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3 D835H demonstrated decreased proliferation in response to Olverembatinib (HQP1351) in culture, but were less sensitive to treatment than cells expressing other FLT3 kinase domain mutations (PMID: 32247263).	32247263
FLT3 D835V	hematologic cancer	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3 D835V demonstrated decreased proliferation in response to Olverembatinib (HQP1351) in culture, but were less sensitive to treatment than cells expressing other FLT3 kinase domain mutations (PMID: 32247263).	32247263
FLT3 D835Y	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3 D835Y in culture (PMID: 32247263).	32247263
FLT3 exon 14 ins	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD in culture (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 D835A	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD and FLT3 D835A in culture (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 D835G	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD and FLT3 D835G in culture (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 D835I	hematologic cancer	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 D835I demonstrated decreased proliferation in response to Olverembatinib (HQP1351) in culture, but were less sensitive to treatment than cells co-expressing FLT3-ITD with other FLT3 kinase domain mutations (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 D835N	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD and FLT3 D835N in culture (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 D835V	hematologic cancer	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 D835V demonstrated decreased proliferation in response to Olverembatinib (HQP1351) in culture, but were less sensitive to treatment than cells co-expressing FLT3-ITD with other FLT3 kinase domain mutations (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 D835Y	hematologic cancer	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 D835Y demonstrated decreased proliferation in response to Olverembatinib (HQP1351) in culture, but were less sensitive to treatment than cells co-expressing FLT3-ITD with other FLT3 kinase domain mutations (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 G697R	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD and FLT3 G697R in culture (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 N676D	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD and FLT3 N676D in culture (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 Y842H	hematologic cancer	sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD and FLT3 Y842H in culture (PMID: 32247263).	32247263
FLT3 R834Q	hematologic cancer	predicted - sensitive	Olverembatinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3 R834Q demonstrated decreased proliferation in response to Olverembatinib (HQP1351) in culture, but were less sensitive to treatment than cells expressing other FLT3 kinase domain mutations (PMID: 32247263).	32247263
FLT3 exon 14 ins FLT3 Y842R	hematologic cancer	sensitive	Olverembatinib	Preclinical	Actionable	In a preclinical study, Olverembatinib (HQP1351) inhibited growth of transformed cells expressing FLT3-ITD and FLT3 Y842R in culture (PMID: 32247263).	32247263

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries
NCT06817720	Phase II	Olverembatinib	Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase	Not yet recruiting	USA
NCT04260022	Phase I	Olverembatinib	Study of HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (HQP1351CU101)	Recruiting	USA
NCT06423911	Phase III	Bosutinib + Olverembatinib Olverembatinib	Study of Olverembatinib (HQP1351) in Patients With CP-CML (POLARIS-2)	Recruiting	USA

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