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| Therapy Name | NVL-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, PMID: 39269178). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| NVL-655 | NVL655|NUV-655|NUV655 | ALK Inhibitor 32 | NVL-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 (PMID: 39269178). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| EML4 - ALK ALK G1202del | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK G1202del in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK G1202R | lung non-small cell carcinoma | predicted - sensitive | NVL-655 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, NVL-655 inhibited Alk signaling and growth in patient-derived non-small cell lung cancer cell lines harboring EML4-ALK and ALK G1202R in culture and decreased brain tumor growth and improved survival in a patient-derived intracranial xenograft model (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK T1151dup | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK T1151dup (reported as T1151insT) in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK S1206Y | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK S1206Y in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK L1196M | lung non-small cell carcinoma | sensitive | NVL-655 | Preclinical - Patient cell culture | Actionable | In a preclinical study, NVL-655 inhibited Alk signaling and growth in a patient-derived non-small cell lung cancer cell line harboring EML4-ALK and ALK L1196M in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK F1174C ALK G1202R | lung adenocarcinoma | sensitive | NVL-655 | Case Reports/Case Series | Actionable | In a Phase I trial (ALKOVE-1), NVL-655 treatment resulted in a partial response with treatment ongoing for at least 9 months in a patient with metastatic lung adenocarcinoma harboring EML4-ALK with ALK G1202R and F1174C in cis (PMID: 39269178; NCT05384626). | 39269178 |
| EML4 - ALK ALK D1203N | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 moderately inhibited viability of cells expressing EML4-ALK and ALK D1203N in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK | lung non-small cell carcinoma | sensitive | NVL-655 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, NVL-655 inhibited growth of a patient-derived non-small cell lung cancer cell line harboring EML4-ALK in culture and inhibited growth of a cell line xenograft model (PMID: 39269178). | 39269178 |
| ALK fusion | lung non-small cell carcinoma | predicted - sensitive | NVL-655 | Phase I | Actionable | In a Phase I trial (ALKOVE-1), NVL-655 treatment demonstrated activity in patients with ALK-positive non-small cell lung cancer (including patients with ALK fusion with or without secondary ALK mutations), resulting in a response rate of 38% (39/103), a median duration of response (DOR) of 9.2 months, DOR greater than 6 months in 79% of patients, and a response rate of 39% (15/38) at the RP2D dose of 150mg (Ann Oncol (2024) 35 (suppl_2): S802-S803; NCT05384626). | detail... |
| ALK act mut | neuroblastoma | predicted - sensitive | NVL-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 ALK L1198F ALK G1202R | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK, ALK G1202R, and ALK L1198F in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK I1171T | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 moderately inhibited viability of cells expressing EML4-ALK and ALK I1171T in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK I1171N ALK L1198F | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 moderately inhibited viability of cells expressing EML4-ALK, ALK I1171N, and ALK L1198F in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK L1198F | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK L1198F in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK L1196M | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 moderately inhibited viability of cells expressing EML4-ALK and ALK L1196M in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK G1269A | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 moderately inhibited viability of cells expressing EML4-ALK and ALK G1269A in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK G1202R ALK G1269A | lung adenocarcinoma | predicted - sensitive | NVL-655 | Case Reports/Case Series | Actionable | In a Phase I trial (ALKOVE-1), NVL-655 treatment resulted in a partial response with treatment ongoing for at least 5 months in a patient with metastatic lung adenocarcinoma harboring EML4-ALK, ALK G1202R, and ALK G1269A (PMID: 39269178; NCT05384626). | 39269178 |
| EML4 - ALK ALK T1151M ALK G1202R | lung non-small cell carcinoma | sensitive | NVL-655 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, NVL-655 inhibited Alk signaling and viability of a patient-derived non-small cell lung cancer cell line expressing EML4-ALK, ALK G1202R, and ALK T1151M in culture and induced tumor regression in a patient-derived xenograft (PDX) model (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK I1171N ALK D1203N | Advanced Solid Tumor | resistant | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 did not inhibit viability of cells expressing EML4-ALK, ALK I1171N, and ALK D1203N (PMID: 39269178). | 39269178 |
| ALK del exon2-17 | sarcoma | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of a soft tissue sarcoma cell line harboring a deletion of ALK exons 2-17 in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK T1151M ALK G1202R | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK, ALK G1202R, and ALK T1151M in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK G1202R ALK G1269A | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK, ALK G1202R, and ALK G1269A in culture and induced tumor regression in a transplant model (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK L1196Q | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK L1196Q in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK S1206F | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK S1206F in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK G1202R | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK G1202R in culture and inhibited tumor growth in a transplant model (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK C1156Y | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK C1156Y in culture (PMID: 39269178). | 39269178 |
| ALK F1174L | neuroblastoma | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of neuroblastoma cell lines harboring ALK F1174L in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK E1210K | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK E1210K in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK V1180L | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK V1180L in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK L1196M ALK G1202R | lung non-small cell carcinoma | sensitive | NVL-655 | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, NVL-655 inhibited Alk signaling and viability of a patient-derived non-small cell lung cancer cell line harboring EML4-ALK, ALK G1202R, and ALK L1196M in culture and induced tumor regression in a patient-derived xenograft (PDX) model and a cell line xenograft model (PMID: 39269178). | 39269178 |
| ALK amp | neuroblastoma | predicted - sensitive | NVL-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 | NVL-655 | Preclinical | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK, ALK G1202R, and ALK L1196M in culture and induced tumor regression in a transplant model and decreased brain tumor volume and increased survival in an intracranial transplant model (PMID: 39269178). | 39269178 |
| EML4 - ALK | lung adenocarcinoma | sensitive | NVL-655 | Case Reports/Case Series | Actionable | In a Phase I trial (ALKOVE-1), NVL-655 treatment resulted in a complete response in the central nervous system metastases and an overall partial response with treatment ongoing for at least 9 months in a patient with metastatic lung adenocarcinoma harboring EML4-ALK (PMID: 39269178; NCT05384626). | 39269178 |
| EML4 - ALK ALK T1151M | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK and ALK T1151M in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK I1171S | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 moderately inhibited viability of cells expressing EML4-ALK and ALK I1171S in culture (PMID: 39269178). | 39269178 |
| ALK fusion ALK G1202R | lung non-small cell carcinoma | predicted - sensitive | NVL-655 | Phase I | Actionable | In a Phase I trial (ALKOVE-1), NVL-655 treatment demonstrated activity in patients with ALK-positive non-small cell lung cancer (including patients with ALK fusion with or without secondary ALK mutations), with a response rate of 76% (22/29), a median duration of response (DOR) of 14.4 mo, DOR greater than 6 months in 88% of patients, and a response rate of 83% (10/12) at the RP2D dose of 150mg in patients harboring an ALK fusion with ALK G1202R (Ann Oncol (2024) 35 (suppl_2): S802-S803; NCT05384626). | detail... |
| EML4 - ALK ALK F1174L ALK G1202R | Advanced Solid Tumor | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of cells expressing EML4-ALK, ALK G1202R, and ALK F1174L in culture (PMID: 39269178). | 39269178 |
| ALK del exon2-3 ALK amp | neuroblastoma | sensitive | NVL-655 | Preclinical - Cell culture | Actionable | In a preclinical study, NVL-655 inhibited viability of an ALK-amplified neuroblastoma cell line harboring a deletion of ALK exons 2-3 in culture (PMID: 39269178). | 39269178 |
| EML4 - ALK ALK I1171N | Advanced Solid Tumor | predicted - sensitive | NVL-655 | Preclinical | Actionable | In a preclinical study, NVL-655 moderately inhibited viability cells expressing EML4-ALK and ALK I1171N in culture and inhibited tumor growth in a transplant model (PMID: 39269178). | 39269178 |
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- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
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- Click on any column header arrows to sort by that column
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05384626 | Phase Ib/II | NVL-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 | NLD | ITA | GBR | FRA | ESP | DEU | CHE | CAN | BEL | AUS | 4 |
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