背景:胃癌是全球第五大常见癌症和第四大癌症死亡原因,然而,晚期疾病的预后仍然很差。
方法:这是一个随机的,双盲,2期试验(ClinicalTrials.gov:NCT04908813)。局部晚期/转移性HER2阳性胃/胃食管交界处癌且先前未接受系统性抗肿瘤治疗的患者随机分为1:1:1至25mg/kgHLX22(一种新型抗HER2抗体)+HLX02(曲妥珠单抗生物仿制药)+奥沙利铂和卡培他滨(XELOX)(A组),15mg/kgHLX22+HLX02+XELOX(B组),或安慰剂+HLX02+XELOX(C组),为期3周。主要终点是由独立放射学审查委员会(IRRC)评估的无进展生存期(PFS)和客观缓解率(ORR)。
结果:在2021年11月29日至2022年6月6日之间,筛选了82例患者;53例随机分为A组(n=18),B(n=17),和C(n=18)。中位随访14.3个月,添加HLX22后,IRRC评估的中位PFS延长(A与C,15.1vs.8.2个月,风险比[HR]0.5[95%置信区间(CI)0.17-1.27];B与C,未达到vs.8.2个月,HR0.1[95%CI0.04-0.52])。确认的ORR在组间具有可比性(A与Bvs.C,77.8%vs.82.4%vs.88.9%)。治疗相关的不良事件(TRAEs)观察到18(100%),16(94.1%),和17名(94.4%)患者,分别。C组中的一名(5.6%)患者报告5级TRAE。
结论:在HER2阳性胃癌一线治疗中,在HLX02和XELOX中添加HLX22可延长PFS并增强抗肿瘤反应,具有可管理的安全性。
背景:上海亨利乌斯生物技术,Inc.
BACKGROUND: Gastric cancer is the fifth most common cancer and the fourth most common cause of cancer death worldwide, yet the prognosis of advanced disease remains poor.
METHODS: This was a randomized, double-blinded, phase 2 trial (ClinicalTrials.gov: NCT04908813). Patients with locally advanced/metastatic HER2-positive gastric/gastroesophageal junction cancer and no prior systemic antitumor therapy were randomized 1:1:1 to 25 mg/kg
HLX22 (a novel anti-HER2 antibody) + HLX02 (trastuzumab biosimilar) + oxaliplatin and capecitabine (XELOX) (group A), 15 mg/kg
HLX22 + HLX02 + XELOX (group B), or placebo + HLX02 + XELOX (group C) in 3-week cycles. Primary endpoints were progression-free survival (PFS) and objective response rate (ORR) assessed by independent radiological review committee (IRRC).
RESULTS: Between November 29, 2021, and June 6, 2022, 82 patients were screened; 53 were randomized to group A (n = 18), B (n = 17), and C (n = 18). With 14.3 months of median follow-up, IRRC-assessed median PFS was prolonged with the addition of
HLX22 (A vs. C, 15.1 vs. 8.2 months, hazard ratio [HR] 0.5 [95% confidence interval (CI) 0.17-1.27]; B vs. C, not reached vs. 8.2 months, HR 0.1 [95% CI 0.04-0.52]). Confirmed ORR was comparable among groups (A vs. B vs. C, 77.8% vs. 82.4% vs. 88.9%). Treatment-related adverse events (TRAEs) were observed in 18 (100%), 16 (94.1%), and 17 (94.4%) patients, respectively. One (5.6%) patient in group C reported a grade 5 TRAE.
CONCLUSIONS: Adding
HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric cancer, with manageable safety.
BACKGROUND: Shanghai Henlius Biotech, Inc.