Selpercatinib在RET融合阳性非小细胞肺癌患者LIBRETTO-001 I/II期试验

SCI天天读 · 公众号 · · 2025-03-18 20:00

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SCI

18 March 2025

Selpercatinib in RET Fusion–Positive Non–Small Cell Lung Cancer: Final Safety and Efficacy, Including Overall Survival, From the LIBRETTO-001 Phase I/II Trial

_{(Journal of Clinical Oncology, IF: 42.1)}

Oliver Gautschi; Keunchil Park; Benjamin J. Solomon; Pascale Tomasini; Herbert H. Loong; Filippo De Braud; Koichi Goto; Patrick Peterson; Scott Barker; Katherine Liming; Geoffrey R. Oxnard; Bente Frimodt-Moller; and Alexander Drilon
CORRESPONDEDNCE TO: [email protected].

Abstract 摘要

LIBRETTO-001 (ClinicalTrials.gov identifier: NCT03157128) is a registrational phase I/II, single-arm, open-label trial of selpercatinib in RET-dependent cancers. With 19 months of additional follow-up, we report the final efficacy and safety results of selpercatinib in patients with RET fusion–positive non–small cell lung cancer (NSCLC) who had previously received platinum-based chemotherapy (N = 247) or were treatment-naive (N = 69). The objective response rate (ORR) was 62% for pretreated patients and 83% for treatment-naive patients. Duration of response (DoR) was 31.6 months for pretreated and 20.3 months for treatment-naive patients (median follow-up approximately 38 months). Median progression-free survival (PFS) was 26.2 months for pretreated and 22.0 months for treatment-naive patients (median follow-up approximately 40 months). Median overall survival was 47.6 months in pretreated patients and was not reached in the treatment-naive group (median follow-up approximately 43 months). At the 3-year landmark estimate, 57% of pretreated and 66% of treatment-naive patients were alive. Among 26 patients with measurable CNS metastases at baseline, the CNS-ORR was 85% with a CNS-DoR of 9.4 months and CNS-PFS of 11.0 months. The safety profile of Selpercatinib was consistent with previous reports. With substantial additional follow-up, Selpercatinib continued to show durable responses and intracranial activity, with a manageable safety profile in patients with RET fusion–positive NSCLC.

LIBRETTO-001（ClinicalTrials.gov编号：NCT03157128）是一项注册性 I/II 期单臂开放标签临床试验，评估Selpercatinib在RET依赖性癌症中的疗效。经过19个月的额外随访，我们报告了Selpercatinib在之前接受过铂类化疗（N=247）或未曾接受过治疗（N=69）的RET融合阳性非小细胞肺癌（NSCLC）患者中的最终疗效和安全性结果。对于接受过治疗的患者，客观缓解率（ORR）为62%，而未曾接受过治疗的患者为83%。治疗持续时间（DoR）在接受过治疗的患者中为31.6个月，在未曾接受过治疗的患者中为20.3个月（中位随访约38个月）。中位无进展生存期（PFS）在接受过治疗的患者中为26.2个月，在未曾接受过治疗的患者中为22.0个月（中位随访约40个月）。接受过治疗的患者的中位总生存期为47.6个月，未曾接受过治疗的患者的总生存期尚未达到（中位随访约43个月）。在3年标志性估算中，57%接受过治疗的患者以及66%未曾接受过治疗的患者仍然存活。在基线时存在可检测的中枢神经系统（CNS）转移的26名患者中，CNS-ORR为85%，CNS-DoR为9.4个月，CNS-PFS为11.0个月。Selpercatinib的安全性与先前的报告一致。经过大幅延长的随访，Selpercatinib继续显示出持久的疗效和颅内活性，并在RET融合阳性非小细胞肺癌患者中具有可管理的安全性。

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Selpercatinib在RET融合阳性非小细胞肺癌患者LIBRETTO-001 I/II期试验

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