Therapy Detail
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| Therapy Name | Zidesamtinib |
| Synonyms | |
| Therapy Description |
Zidesamtinib (NUV-520) is a brain-penetrant small molecule inhibitor of ROS1, which potentially inhibits ROS1 kinase activity, decreases tumor cell viability, and reduces tumor growth (PMID: 40299789). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Zidesamtinib | NVL-520|NUV 520|NUV520|NVL 520|NVL520|SIM18031A|NUV-520 | ROS1 Inhibitor 23 | Zidesamtinib (NUV-520) is a brain-penetrant small molecule inhibitor of ROS1, which potentially inhibits ROS1 kinase activity, decreases tumor cell viability, and reduces tumor growth (PMID: 40299789). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ROS1 fusion | lung non-small cell carcinoma | predicted - sensitive | Zidesamtinib | Phase I | Actionable | In a Phase I trial (ARROS-1), Zidesamtinib (NUV-520) treatment demonstrated safety and activity in patients with non-small cell lung cancer harboring a ROS1 fusion, resulting in a response rate of 38% (28/73), including a complete response in 2 patients with a duration of response of at least 16.6 mo and 23.5 mo, and median DOR was not reached (Ann Oncol (2024) 35 (Suppl_2): S804-S805; NCT05118789). | detail... |
| ROS1 D2113N | Advanced Solid Tumor | sensitive | Zidesamtinib | Preclinical - Cell culture | Actionable | In a preclinical study, Zidesamtinib (NUV-520) inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). | 37587872 |
| ROS1 D2113G | Advanced Solid Tumor | sensitive | Zidesamtinib | Preclinical - Cell culture | Actionable | In a preclinical study, Zidesamtinib (NUV-520) inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). | 37587872 |
| ROS1 fusion ROS1 G2032R | lung non-small cell carcinoma | predicted - sensitive | Zidesamtinib | Phase I | Actionable | In a Phase I trial (ARROS-1), Zidesamtinib (NUV-520) treatment demonstrated safety and activity in patients with non-small cell lung cancer harboring a ROS1 fusion, including a response rate of 65% (11/17) with a median duration of response of 15.8 months in repotrectinib-naive patients and a response rate of 38% (3/8) in repotrectinib-pretreated patients harboring a ROS1 fusion and ROS1 G2032R (Ann Oncol (2024) 35 (Suppl_2): S804-S805; NCT05118789). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05118789 | Phase Ib/II | Zidesamtinib | A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) | Recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 4 |
| NCT06797362 | Expanded access | Zidesamtinib | Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC (NVL-520-EAP) | Available | USA | NLD | ITA | GBR | FRA | ESP | CAN | AUS | 2 |
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