Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study.
Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study.
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DOI：
10.1186/s12916-022-02692-8
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发表时间：
2023-01-08
期刊：
影响因子：
9.3
通讯作者：
Wang, Tingting
中科院分区：
文献类型：
--
作者：
Shi, Yuankai;Zhou, Jianying;Zhao, Yanqiu;Zhu, Bo;Zhang, Liangming;Li, Xingya;Fang, Jian;Shi, Jianhua;Zhuang, Zhixiang;Yang, Sheng;Wang, Donglin;Yu, Huiqing;Zhang, Longzhen;Zheng, Rongsheng;Greco, Michael;Wang, Tingting
Rezivertinib（BPI-7711）是一种新型的第三代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）。这项IIa期研究是I/IIa期研究（NCT 03386955）的一部分，旨在评价rezivertinib作为局部晚期或转移性/复发性EGFR突变非小细胞肺癌（NSCLC）患者一线治疗的疗效和安全性。患者接受180 mg rezivertinib口服一线治疗，每日一次，直至疾病进展、不可接受的毒性或撤回知情同意。主要终点是通过设盲独立中心审查（BICR）评估的客观缓解率（ORR）。次要终点包括疾病控制率（DCR）、缓解持续时间（DoR）、无进展生存期（PFS）、总生存期（OS）和安全性。从2019年6月12日至2019年10月17日，入组了43例患者。截至数据截止日期2021年12月23日，BICR评估的ORR为83.7%（95%CI：69.3-93.2%）。中位DoR为19.3（95% CI：15.8-25.0）个月。BICR评估的中位PFS为20.7（95% CI：13.8-24.8）个月，研究者评估的中位PFS为22.0（95% CI：16.8-26.3）个月。操作系统上的数据不成熟。共有40例（93.0%）患者至少发生1起治疗相关不良事件，其中4例（9.3%）为≥ 3级。Rezivertinib（BPI-7711）在一线治疗EGFR突变的局部晚期或转移/复发NSCLC患者中显示出良好的疗效和良好的安全性。ClinicalTrials.gov，NCT 03386955。在线版本包含补充材料，可通过10.1186/s12916-022-02692-8获得。
Rezivertinib (BPI-7711) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This phase IIa study was part of a phase I/IIa study (NCT03386955), aimed to evaluate the efficacy and safety of rezivertinib as the first-line treatment for patients with locally advanced or metastatic/recurrent EGFR mutated non-small cell lung cancer (NSCLC). Patients received the first-line treatment of 180 mg rezivertinib orally once daily until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the objective response rate (ORR) assessed by blinded independent central review (BICR). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. From Jun 12, 2019, to Oct 17, 2019, 43 patients were enrolled. At the data cutoff date on Dec 23, 2021, the ORR by BICR was 83.7% (95% CI: 69.3–93.2%). The median DoR was 19.3 (95% CI: 15.8–25.0) months. The median PFS by BICR was 20.7 (95% CI: 13.8–24.8) months and 22.0 (95% CI: 16.8–26.3) months by investigators. Data on OS was immature. Totally, 40 (93.0%) patients had at least one treatment-related adverse event while 4 (9.3%) of them were grade ≥ 3. Rezivertinib (BPI-7711) showed promising efficacy and a favorable safety profile for the treatment among the locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation in the first-line setting. ClinicalTrials.gov, NCT03386955. The online version contains supplementary material available at 10.1186/s12916-022-02692-8.
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作者：
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