Efficacy and Safety Analysis of Selpercatinib in Patients with RET Fusion-Positive Non-Small Cell Lung Cancer-Results from the Japanese Subset of a Global Phase 1/2 Study
PURPOSE: Selpercatinib is a highly selective, potent, rearranged during transfection(RET)inhibitor. A global, multicenter, open-label, phase 1/2 study of selpercatinib(LIBRETTO-001, NCT03157128)has been ongoing since 2017. We evaluated the data of Japanese patients with RET fusion-positive non-small cell lung cancer(NSCLC)using 30 March 2020 cut-off data.
METHODS: Phase 2 of LIBRETTO-001 started after confirming the safety of the recommended phase 2 dose(160 mg bid, orally, 28-day cycles)in Japanese. The primary endpoint was the independently assessed objective response rate(RECIST v1.1).
RESULTS: Japanese NSCLC patients, including 44 patients in cohort 1 who had previously received platinum-based(or other)chemotherapy, programmed cell death-1/programmed death-ligand 1 immunotherapy, or both, and four previously untreated patients in cohort 2, were analyzed. The objective response rate was 55.3%(95% confidence interval: 38.3, 71.4; one confirmed complete response, 20 confirmed partial responses)in 38 evaluable patients in cohort 1 who could be followed for ≥2 post-baseline scans. The only evaluable patient in cohort 2 had no response. The most frequent treatment- emergent adverse events were increased alanine aminotransferase, increased aspartate aminotransferase, and diarrhea.
CONCLUSIONS: Selpercatinib appeared to be effective in Japanese patients with RET fusion-positive NSCLC, and the safety profile was not substantially different from published results.
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:49 |
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| Enthalten in: |
Gan to kagaku ryoho. Cancer & chemotherapy - 49(2022), 6 vom: 25. Juni, Seite 669-675 |
| Sprache: |
Japanisch |
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| Beteiligte Personen: |
Nishio, Makoto [VerfasserIn] |
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| Themen: |
CEGM9YBNGD |
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| Anmerkungen: |
Date Completed 11.07.2022 Date Revised 11.07.2022 published: Print Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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NLM343199602 |
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| 245 | 1 | 0 | |a Efficacy and Safety Analysis of Selpercatinib in Patients with RET Fusion-Positive Non-Small Cell Lung Cancer-Results from the Japanese Subset of a Global Phase 1/2 Study |
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| 520 | |a PURPOSE: Selpercatinib is a highly selective, potent, rearranged during transfection(RET)inhibitor. A global, multicenter, open-label, phase 1/2 study of selpercatinib(LIBRETTO-001, NCT03157128)has been ongoing since 2017. We evaluated the data of Japanese patients with RET fusion-positive non-small cell lung cancer(NSCLC)using 30 March 2020 cut-off data | ||
| 520 | |a METHODS: Phase 2 of LIBRETTO-001 started after confirming the safety of the recommended phase 2 dose(160 mg bid, orally, 28-day cycles)in Japanese. The primary endpoint was the independently assessed objective response rate(RECIST v1.1) | ||
| 520 | |a RESULTS: Japanese NSCLC patients, including 44 patients in cohort 1 who had previously received platinum-based(or other)chemotherapy, programmed cell death-1/programmed death-ligand 1 immunotherapy, or both, and four previously untreated patients in cohort 2, were analyzed. The objective response rate was 55.3%(95% confidence interval: 38.3, 71.4; one confirmed complete response, 20 confirmed partial responses)in 38 evaluable patients in cohort 1 who could be followed for ≥2 post-baseline scans. The only evaluable patient in cohort 2 had no response. The most frequent treatment- emergent adverse events were increased alanine aminotransferase, increased aspartate aminotransferase, and diarrhea | ||
| 520 | |a CONCLUSIONS: Selpercatinib appeared to be effective in Japanese patients with RET fusion-positive NSCLC, and the safety profile was not substantially different from published results | ||
| 650 | 4 | |a Clinical Trial, Phase I | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
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