Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial

IF 4.5 2区 医学 Q1 ONCOLOGY
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Abstract

Background

In the initial analysis of a pivotal phase 2 single-arm study (NCT03861156), befotertinib (D-0316) showed clinical benefit with a manageable safety profile in pretreated patients with EGFR T790M mutated non-small cell lung cancer (NSCLC), including those with brain metastases.

Methods

Eligible patients received oral befotertinib of 50 mg (cohort A) or 75–100 mg (cohort B) once daily until disease progression, withdrawal of informed consent, or death. The primary endpoint for the initial analysis was objective response rate (ORR) assessed by an independent review committee. OS and safety were secondary endpoints. Herein, we present the final OS and safety data.

Results

A total of 176 patients in cohort A and 290 patients in cohort B were finally enrolled. At data cutoff (May 31, 2023), the median duration of follow-up was 47.9 months (95 % CI: 47.1–48.3) in cohort A and 36.7 months (35.9–37.9) in cohort B. The median OS was 23.9 months (95 % CI: 21.1–27.2) in cohort A and 31.5 months (26.8–35.3) in cohort B. The median OS for patients with and without brain metastasis in cohort A was 18.6 months (95 % CI: 14.9–26.3) and 26.4 months (95 % CI: 23.0–29.0), respectively. In cohort B, these data was 23.0 months (95 % CI: 18.6–29.1) and 35.5 months (95 % CI: 29.3–NE), respectively. The safety profile of befotertinib remained consistent with previous data. Grade 3 or higher treatment-emergent adverse events were 38.1 % in the cohort A and 50.3 % in the cohort B, and 22.2 % and 31.7 % were related to the study drug.

Conclusion

Befotertinib demonstrated a more profound OS benefit compared to other 3rd-generation EGFR TKI, despite that cross trial data comparison should be interpreted with caution. The safety profile was manageable and consistent with previously report data in pretreated patients with confirmed T790M mutation-positive NSCLC.

贝福替尼用于治疗表皮生长因子受体(EGFR)T790M突变的局部晚期或转移性NSCLC患者:2期试验的最终总生存期结果
背景在一项关键性2期单臂研究(NCT03861156)的初步分析中,贝福替尼(D-0316)对表皮生长因子受体(EGFR)T790M突变的非小细胞肺癌(NSCLC)患者(包括脑转移患者)的预处理显示出临床获益和可控的安全性。方法符合条件的患者每天一次口服50毫克(A组)或75-100毫克(B组)贝福替尼,直至疾病进展、撤销知情同意或死亡。初步分析的主要终点是由独立审查委员会评估的客观反应率(ORR)。OS和安全性是次要终点。结果 A组共有176名患者入组,B组共有290名患者入组。截至数据截止日(2023 年 5 月 31 日),A 组的中位随访时间为 47.9 个月(95 % CI:47.1-48.3),B 组为 36.7 个月(35.9-37.9)。在 A 组群中,有脑转移和无脑转移患者的中位 OS 分别为 18.6 个月(95 % CI:14.9-26.3)和 26.4 个月(95 % CI:23.0-29.0)。在队列 B 中,这些数据分别为 23.0 个月(95 % CI:18.6-29.1)和 35.5 个月(95 % CI:29.3-NE)。贝福替尼的安全性与之前的数据保持一致。A组和B组分别有38.1%和50.3%的患者出现3级或3级以上的治疗突发不良事件,其中22.2%和31.7%与研究药物有关。该药的安全性是可控的,与之前报告的T790M突变阳性NSCLC患者的预处理数据一致。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Lung Cancer
Lung Cancer 医学-呼吸系统
CiteScore
9.40
自引率
3.80%
发文量
407
审稿时长
25 days
期刊介绍: Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.
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