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Therapy Name Iruplinalkib
Synonyms
Therapy Description

Iruplinalkib (WX-0593) inhibits ALK and ROS1, with additional activity against EGFR mutations, which may lead to decreased tumor growth (PMID: 35087031; Cancer Res 2018;78(13 Suppl):Abstract nr 4794).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Iruplinalkib WX0593|WX 0593|FL 006|FL-006|FL006|WX-0593 ALK Inhibitor 32 EGFR Inhibitor (Pan) 62 ROS1 Inhibitor 20 Iruplinalkib (WX-0593) inhibits ALK and ROS1, with additional activity against EGFR mutations, which may lead to decreased tumor growth (PMID: 35087031; Cancer Res 2018;78(13 Suppl):Abstract nr 4794).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 rearrange lung non-small cell carcinoma sensitive Iruplinalkib Phase I Actionable In a Phase I trial, Iruplinalkib (WX-0593) demonstrated safety and resulted in an objective response rate (ORR) of 56.6% (56/99; all partial responses) and a disease control rate (DCR) of 83.8% (83/99), and median duration of response and median progression-free survival were not reached in non-small cell lung cancer patients with an ALK or ROS1-rearrangement, with an ORR of 44.4% (4/9) and DCR of 66.7% (6/9) in patients with a ROS1 rearrangement (PMID: 35087031). 35087031
ALK rearrange lung non-small cell carcinoma sensitive Iruplinalkib Phase I Actionable In a Phase I trial, Iruplinalkib (WX-0593) demonstrated safety and resulted in an objective response rate (ORR) of 56.6% (56/99; all partial responses) and a disease control rate (DCR) of 83.8% (83/99), and median duration of response and median progression-free survival were not reached in non-small cell lung cancer patients with an ALK or ROS1-rearrangement, with an ORR of 58.2% (53/91; all partial responses) and DCR of 85.7% (78/91) in patients with an ALK rearrangement (PMID: 35087031; NCT03389815). 35087031
ALK rearrange lung non-small cell carcinoma sensitive Iruplinalkib Phase III Actionable In a Phase III trial (INSPIRE), Iruplinalkib (WX-0593) treatment in ALK-positive non-small cell lung cancer patients resulted in a significantly improved median progression free survival (mPFS) of 27.7 months, improved objective response rate (ORR) of 93.0% (133/143), and intracranial ORR of 90.9% (10/11) compared to a mPFS of 14.6 months (HR=0.34, p<0.0001), ORR of 89.3% (133/149), and intracranial ORR of 60.0% (9/15) with Xalkori (crizotinib) treatment (PMID: 38280448; NCT04632758). 38280448
ALK rearrange lung non-small cell carcinoma sensitive Iruplinalkib Phase II Actionable In a Phase II trial (INTELLECT), Iruplinalkib (WX-0593) treatment resulted in an IRC-assessed objective response rate (ORR) of 69.9% (102/146), investigator-assessed ORR of 63.0%, disease control rate of 94.5%, and median progression-free survival of 14.5 months in patients with ALK-positive, Crizotinib-resistant non-small cell lung cancer, and an intracranial ORR of 46% (41/90) and 64% (27/42) for patients with CNS metastases or measurable intracranial lesions, respectively (PMID: 36829154; NCT04641754). 36829154
EML4 - ALK ALK G1202R Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK G1202R in culture (PMID: 35421578). 35421578
EML4 - ALK Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) inhibited growth of transformed cells expressing EML4-ALK in culture (PMID: 35421578). 35421578
EML4 - ALK ALK I1171N Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK I1171N in culture (PMID: 35421578). 35421578
EML4 - ALK ALK L1152P Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK L1152P in culture (PMID: 35421578). 35421578
EML4 - ALK ALK F1174L Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK F1174L in culture (PMID: 35421578). 35421578
EML4 - ALK lung non-small cell carcinoma sensitive Iruplinalkib Preclinical - Pdx Actionable In a preclinical study, Iruplinalkib (WX-0593) inhibited tumor growth in a patient-derived xenograft (PDX) model of non-small cell lung cancer harboring EML4-ALK (PMID: 35421578). 35421578
EML4 - ALK lung non-small cell carcinoma sensitive Iruplinalkib Preclinical - Cell line xenograft Actionable In a preclinical study, Iruplinalkib (WX-0593) inhibited tumor growth in a non-small cell lung cancer cell line xenograft model harboring EML4-ALK (PMID: 37036582). 37036582
EML4 - ALK ALK F1174C Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK F1174C in culture (PMID: 35421578). 35421578
EML4 - ALK ALK I1171T Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK I1171T in culture (PMID: 35421578). 35421578
EML4 - ALK ALK F1174V Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK F1174V in culture (PMID: 35421578). 35421578
EML4 - ALK ALK C1156Y Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) inhibited growth of transformed cells expressing ALK C1156Y in the context of EML4-ALK in culture (PMID: 35421578). 35421578
EML4 - ALK ALK I1171S Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK I1171S in culture (PMID: 35421578). 35421578
EML4 - ALK ALK L1152R Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK L1152R in culture (PMID: 35421578). 35421578
EML4 - ALK ALK L1196M Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) inhibited growth of transformed cells expressing ALK L1196M in the context of EML4-ALK in culture (PMID: 35421578). 35421578
EML4 - ALK ALK V1180L Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK V1180L in culture (PMID: 35421578). 35421578
EML4 - ALK ALK T1151dup Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK T1151dup in culture (PMID: 35421578). 35421578
EML4 - ALK ALK G1269A Advanced Solid Tumor sensitive Iruplinalkib Preclinical - Cell culture Actionable In a preclinical study, Iruplinalkib (WX-0593) treatment inhibited viability of transformed cells expressing EML4-ALK with ALK G1269A in culture (PMID: 35421578). 35421578

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries


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