【佳學基因靶向藥物基因檢測】來自 I/IIa 期研究的評估 rezivertinib (BPI-7711) 一線治療具有 EGFR 突變的局部晚期或轉(zhuǎn)移性/反復性 NSCLC 患者療效和安全性的 IIa 期研究結(jié)果

基因檢測公司國內(nèi)排名時機窗口

開題評估腫瘤啟動預防及腫瘤檢測《腫瘤基因計劃》與預防策略的實施度《BMC Med》在?2023 Jan 8;21(1):11.發(fā)表了一篇題目為《Clinical Trial》腫瘤靶向藥物治療基因檢測臨床研究文章。該研究由Yuankai Shi,?Jianying Zhou,?Yanqiu Zhao,?Bo Zhu,?Liangming Zhang,?Xingya Li,?Jian Fang,?Jianhua Shi,?Zhixiang Zhuang,?Sheng Yang,?Donglin Wang,?Huiqing Yu,?Longzhen Zhang,?Rongsheng Zheng,?Michael Greco,?Tingting Wang等完成。促進了腫瘤的正確治療與個性化用藥的發(fā)展，進一步強調(diào)了基因信息檢測與分析的重要性。

腫瘤基因檢測及靶向藥物治療研究關(guān)鍵詞：

BPI-7711,表皮生長因子受體突變,非小細胞肺癌,瑞維替尼,第三代EGFR TKI。

腫瘤治療檢測基因臨床應用結(jié)果

靶向藥物研究立項的依據(jù)：Rezivertinib (BPI-7711) 是一種新型第三代表皮生長因子受體 (EGFR) 酪氨酸激酶抑制劑 (TKI)。這項 IIa 期研究是 I/IIa 期研究 (NCT03386955) 的一部分，旨在評估 rezivertinib 作為一線治療局部晚期或轉(zhuǎn)移性/反復性 EGFR 突變非小細胞肺癌患者的療效和安全性（ NSCLC）。佳學基因解碼的途徑：患者接受每日一次口服 180 mg rezivertinib 的一線治療，直至疾病進展、不可接受的毒性或撤回同意。主要終點是通過盲法獨立中央審查（BICR）評估的客觀緩解率（ORR）。次要終點包括疾病控制率 (DCR)、反應持續(xù)時間 (DoR)、無進展生存期 (PFS)、總生存期 (OS) 和安全性。靶向藥物研究的客觀數(shù)據(jù)：2019 年 6 月 12 日至 2019 年 10 月 17 日，43 名患者被錄取了。在 2021 年 12 月 23 日的數(shù)據(jù)截止日期，BICR 的 ORR 為 83.7%（95% CI：69.3-93.2%）。中位 DoR 為 19.3（95% CI：15.8-25.0）個月。 BICR 的中位 PFS 為 20.7（95% CI：13.8-24.8）個月，研究人員為 22.0（95% CI：16.8-26.3）個月。 OS 上的數(shù)據(jù)不成熟?？偣灿?40 名 (93.0%) 患者出現(xiàn)至少一次與治療相關(guān)的不良事件，其中 4 名 (9.3%) 為 ≥ 3 級。 EGFR 突變的局部晚期或轉(zhuǎn)移性/反復性 NSCLC 患者一線治療。試驗注冊：ClinicalTrials.gov，NCT03386955。關(guān)鍵詞：BPI-7711；表皮生長因子受體突變；非小細胞肺癌；瑞維替尼；第三代EGFR TKI。

腫瘤發(fā)生與革命國際數(shù)據(jù)庫描述：

Background:?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).Methods:?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.Results:?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.Conclusions:?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.Trial registration:?ClinicalTrials.gov,?NCT03386955.Keywords:?BPI-7711; EGFR mutation; NSCLC; Rezivertinib; Third-generation EGFR TKI.