| Autor: |
Alexander, Drilon, Vivek, Subbiah, Oliver, Gautschi, Pascale, Tomasini, Filippo, de Braud, Benjamin J, Solomon, Daniel, Shao-Weng Tan, Guzmán, Alonso, Jürgen, Wolf, Keunchil, Park, Koichi, Goto, Victoria, Soldatenkova, Sylwia, Szymczak, Scott S, Barker, Tarun, Puri, Aimee, Bence Lin, Herbert, Loong, Benjamin, Besse |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 41(2) |
| ISSN: |
1527-7755 |
| Popis: |
Selpercatinib, a first-in-class, highly selective, and potent CNS-active RET kinase inhibitor, is currently approved for the treatment of patients withPatients were enrolled to LIBRETTO-001, a phase I/II, single-arm, open-label study of selpercatinib in patients withIn treatment-naive patients, the ORR was 84% (95% CI, 73 to 92); 6% achieved complete responses (CRs). The median DoR was 20.2 months (95% CI, 13.0 to could not be evaluated); 40% of responses were ongoing at the data cutoff (median follow-up of 20.3 months). The median PFS was 22.0 months; 35% of patients were alive and progression-free at the data cutoff (median follow-up of 21.9 months). In platinum-based chemotherapy pretreated patients, the ORR was 61% (95% CI, 55 to 67); 7% achieved CRs. The median DoR was 28.6 months (95% CI, 20.4 to could not be evaluated); 49% of responses were ongoing (median follow-up of 21.2 months). The median PFS was 24.9 months; 38% of patients were alive and progression-free (median follow-up of 24.7 months). Of 26 patients with measurable baseline CNS metastasis by the independent review committee, the intracranial ORR was 85% (95% CI, 65 to 96); 27% were CRs. In the full safety population (n = 796), the median treatment duration was 36.1 months. The safety profile of selpercatinib was consistent with previous reports.In a large cohort with extended follow-up, selpercatinib continued to demonstrate durable and robust responses, including intracranial activity, in previously treated and treatment-naive patients with |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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