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172P Trastuzumab deruxtecan (T-DXd) in Chinese patients (pts) with previously treated HER2-positive locally advanced/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary efficacy and safety from the phase II single-arm DESTINY-Gastric06 (DG06) trial

医学 曲妥珠单抗 胃食管交界处 肿瘤科 内科学 癌症 腺癌 胃腺癌 乳腺癌
作者
Lin Shen,Pei Chen,Jun Lü,Yueping Wan,Yang Zheng,Fayin Ye,Jingcheng Yang,Y. Liu,Hongming Pan,Hui Chen,Meili Sun,Qiang Fan,Yuan Yang,Ken Chen,Ziyong Sun,He Tian,Xianjiang Ye,Zhi Peng
出处
期刊:Annals of Oncology [Elsevier BV]
卷期号:34: S1542-S1543 被引量:1
标识
DOI:10.1016/j.annonc.2023.10.307
摘要

For pts with HER2-positive advanced/recurrent GC/GEJA in China, treatment options are limited. T-DXd is a HER2-directed antibody-drug conjugate; T-DXd 6.4 mg/kg is approved in the US, EU, Japan, South Korea and Singapore for treatment of locally advanced/metastatic GC/GEJA in adults who received a prior trastuzumab-based regimen. In DESTINY-Gastric01 (DG01), T-DXd showed significant improvements in response rates and overall survival (OS) versus standard therapies in pts from Japan/South Korea with HER2-positive advanced GC/GEJA. In this open-label, single-arm, phase 2 trial (NCT04989816), Chinese pts with HER2-positive (immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+ by central laboratory) advanced GC/GEJA who had received ≥2 prior treatment regimens, including a fluoropyrimidine and a platinum agent, received T-DXd 6.4 mg/kg intravenous infusion once every 3 weeks. Primary endpoint was confirmed objective response rate (ORR) by independent central review (ICR) per RECIST v1.1. Secondary endpoints included investigator-assessed (INV) confirmed ORR, INV duration of response (DOR), INV progression-free survival (PFS), and OS. Safety and tolerability were assessed. At data cutoff (Jun 16, 2023), 95 pts were enrolled (intent-to-treat [ITT]); 73 pts were confirmed HER2-positive (IHC 3+ or IHC 2+/ISH+; full analysis set [FAS]) by central laboratory. In the FAS, 65.8% of pts were <65 years of age, 72.6% were IHC 3+ and primary tumor location in 30.1% of pts was GEJ. Efficacy and safety data are shown in table. This primary analysis of T-DXd in Chinese pts with HER2-positive advanced GC/GEJA demonstrated clinically meaningful and durable objective responses, with a manageable safety profile, and is consistent with results from DG01.Table: 172PFASN=73Median prior lines of therapy, n (range)2 (2–6)Median duration of follow-up, months (Q1, Q3)8.0 (6.0, 13.2)ICR confirmed ORR, n (%)21 (28.8)INV confirmed ORR, n (%)26 (35.6)Median DOR, months (95% confidence interval [CI])7.9 (4.6, 8.8)Median PFS, months (95% CI)5.7 (4.0, 6.8)Median OS, months (95% CI)10.2 (7.5, 14.3)ITTN=95Median T-DXd duration, months (range)3.4 (0.4,14.5)Grade (G) ≥3 adverse events (AE), n (%)70 (73.7)Discontinued treatment due to AEs, n (%)12 (12.6)Discontinued treatment due to COVID-19-associated AEs, n (%)5 (5.3)Adjudicated drug-related interstitial lung disease/pneumonitis, n (%)3 (3.2)G12 (2.1)G21 (1.1)G3–G50 Open table in a new tab
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