Company to present BDTX-1535 dose escalation data in NSCLC at the AACR-NCI-EORTC Conference in October 2023   CAMBRIDGE, Mass. and NEW YORK, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced the first patients dosed in mutation matched expansion cohorts of non-small cell lung cancer (NSCLC) in the ongoing Phase 1 clinical study evaluating BDTX-1535.

公司于2023年10月在美国马萨诸塞州剑桥市和纽约市2023年9月11日（GLOBE NEWSWIRE）-Black Diamond Therapeutics，Inc。在AACR-NCI-EORTC会议上向NSCLC提交BDTX-1535剂量递增数据（纳斯达克股票代码：BDTX），一家临床阶段精确肿瘤学公司，开发针对基因定义癌症患者致癌突变家族的治疗方法，今天宣布，在正在进行的评估BDTX-1535的1期临床研究中，首批接受突变匹配的非小细胞肺癌（NSCLC）扩增队列研究的患者。

BDTX-1535, a fourth-generation, brain-penetrant epidermal growth factor receptor (EGFR) MasterKey tyrosine kinase inhibitor (TKI), is under investigation for the treatment of NSCLC harboring intrinsic driver and/or acquired resistance (post-osimertinib) EGFR mutations and glioblastoma multiforme (GBM) with multiple EGFR alterations.

BDTX-1535是第四代脑渗透性表皮生长因子受体（EGFR）MasterKey酪氨酸激酶抑制剂（TKI），正在研究用于治疗具有内在驱动和/或获得性耐药（osimertinib后）EGFR突变的NSCLC。和多形性胶质母细胞瘤（GBM）具有多种EGFR改变。

The BDTX-1535 expansion cohort portion of the study will assess single-agent objective response rate (ORR) in a second- or third-line setting in NSCLC patients with EGFR intrinsic driver and/or acquired resistance mutations, who have received prior treatment with approved EGFR TKI. The dosing of the first patients in the expansion cohorts follows the Company’s initial data readout from the dose escalation portion of the BDTX-1535 Phase 1 clinical study, which demonstrated clinical proof of activity through radiographic responses in NSCLC patients harboring diverse types of EGFR mutations including intrinsic driver and post-osimertinib acquired resistance EGFR mutations.

该研究的BDTX-1535扩展队列部分将评估EGFR内在驱动和/或获得性耐药突变的NSCLC患者的二线或三线治疗中的单药客观缓解率（ORR），这些患者先前接受过批准的EGFR TKI。扩展队列中第一批患者的剂量遵循该公司从BDTX-1535第1阶段临床研究的剂量递增部分获得的初始数据读数，其通过在具有不同类型的EGFR的NSCLC患者中的放射照相反应证明了活性的临床证据突变包括内在驱动和osimertinib后获得性EGFR突变。

“The Phase 1 expansion cohorts will assess objective response rate and durability of response in NSCLC patients whose disease has progressed after prior EGFR inhibitor therapy, including prior osimertinib, and who have evidence.

“第一阶段扩展队列将评估先前EGFR抑制剂治疗（包括先前的osimertinib）后患有疾病进展且有证据的NSCLC患者的客观缓解率和缓解持久性。