Medical Oncologist Department, Thoracic Tumor Unit, Vall d'Hebron University Hospital, Barcelona.
Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Ann Oncol. 2018 Jan 1;29(suppl_1):i20-i27. doi: 10.1093/annonc/mdx704.
Osimertinib was the first third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) to receive FDA and EMA approval for metastatic EGFR-mutant non-small-cell lung cancer (NSCLC) patients that have acquired the EGFR T790M resistance mutation. Clinical trials have demonstrated the efficacy of osimertinib in this patient population and clinical trials of other third-generation EGFR TKI are currently under way. Additional challenges in this patient population, such as the upfront efficacy of osimertinib, validation of T790M in liquid biopsies as a dynamic predictive marker of efficacy, along with combination with immune checkpoint inhibitors are being explored, representing an extraordinary time of development for EGFR-mutant NSCLC.
奥希替尼是首个获得美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准用于治疗携带 EGFR T790M 耐药突变的转移性 EGFR 突变型非小细胞肺癌（NSCLC）患者的第三代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）。临床试验已经证明了奥希替尼在这一患者群体中的疗效，其他第三代 EGFR TKI 的临床试验也正在进行中。在这一患者群体中还存在其他挑战，例如奥希替尼的一线疗效、液体活检中 T790M 作为疗效的动态预测标志物的验证，以及与免疫检查点抑制剂联合使用等，这些都在探索之中，代表着 EGFR 突变型 NSCLC 开发的非凡时期。
