Therapy Detail
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| Therapy Name | NUV-655 |
| Synonyms | |
| Therapy Description |
NUV-655 is a brain-penetrant inhibitor of ALK, with activity against ALK fusions and mutations, which may result in decreased cell growth and tumor regression (Cancer Res 2021;81(13_Suppl):Abstract nr 1468). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| NUV-655 | NVL-655|NUV655|NVL655 | ALK Inhibitor 32 | NUV-655 is a brain-penetrant inhibitor of ALK, with activity against ALK fusions and mutations, which may result in decreased cell growth and tumor regression (Cancer Res 2021;81(13_Suppl):Abstract nr 1468). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| EML4 - ALK ALK G1202R | Advanced Solid Tumor | predicted - sensitive | NUV-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NUV-655 treatment resulted in decreased cell growth in a cell line expressing EML4-ALK fusion and ALK G1202R in culture (Cancer Res 2021;81(13_Suppl):Abstract nr 1468). | detail... |
| EML4 - ALK ALK G1202R ALK G1269A | Advanced Solid Tumor | predicted - sensitive | NUV-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NUV-655 treatment resulted in decreased cell growth in a cell line expressing EML4-ALK fusion and ALK mutations, G1202R and G1269A, in culture (Cancer Res 2021;81(13_Suppl):Abstract nr 1468). | detail... |
| EML4 - ALK ALK L1196M ALK G1202R | lung non-small cell carcinoma | predicted - sensitive | NUV-655 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, NUV-655 demonstrated activity in a patient-derived non-small cell lung cancer cell line harboring EML4-ALK with ALK G1202R and ALK L1196M in culture and induced tumor regression in a patient-derived xenograft (PDX) model (Eur J Cancer 2022 Vol 174, Supp 1:S78-S79). | detail... |
| ALK amp | neuroblastoma | predicted - sensitive | NUV-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NUV-655 inhibited proliferation of neuroblastoma cell lines with ALK amplification in culture (Cancer Res (2022) 82 (12_Supplement): 3337). | detail... |
| EML4 - ALK ALK L1196M ALK G1202R | Advanced Solid Tumor | sensitive | NUV-655 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, NUV-655 treatment resulted in decreased growth in cells expressing both EML4-ALK and ALK G1202R and L1196M in culture and resulted in tumor regression in cell-line xenograft models (Cancer Res 2021;81(13_Suppl):Abstract nr 1468). | detail... |
| EML4 - ALK ALK G1202R | lung non-small cell carcinoma | predicted - sensitive | NUV-655 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, NUV-655 demonstrated activity in a patient-derived non-small cell lung cancer cell line harboring EML4-ALK with ALK G1202R in culture and induced tumor regression in a patient-derived xenograft (PDX) model (Eur J Cancer 2022 Vol 174, Supp 1:S78-S79). | detail... |
| ALK act mut | neuroblastoma | predicted - sensitive | NUV-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NUV-655 inhibited proliferation of neuroblastoma cell lines harboring activating mutations in ALK in culture (Cancer Res (2022) 82 (12_Supplement): 3337). | detail... |
| EML4 - ALK | Advanced Solid Tumor | predicted - sensitive | NUV-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NUV-655 treatment resulted in decreased cell growth in a cell line expressing EML4-ALK fusion in culture (Cancer Res 2021;81(13_Suppl):Abstract nr 1468). | detail... |
| EML4 - ALK ALK T1151M ALK G1202R | lung non-small cell carcinoma | predicted - sensitive | NUV-655 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, NUV-655 demonstrated activity in a patient-derived non-small cell lung cancer cell line harboring EML4-ALK with ALK G1202R and ALK T1151M in culture and induced tumor regression in a patient-derived xenograft (PDX) model (Eur J Cancer 2022 Vol 174, Supp 1:S78-S79). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05384626 | Phase Ib/II | NUV-655 | A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) | Recruiting | USA | GBR | FRA | ESP | CAN | AUS | 1 |
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