Primary endpoint of Overall Response Rate at Week 18 met, demonstrating clinical equivalence in patients with advanced non-squamous non-small cell lung cancer

第18周的总缓解率主要终点达到，证明在晚期非鳞状非小细胞肺癌患者中具有临床等效性。

SINGAPORE

新加坡

,

，

March 24, 2026

2026年3月24日

/PRNewswire/ -- Prestige Biopharma today announced positive topline results from its Phase 3 SAMSON-II study evaluating HD204, a proposed biosimilar to Avastin

/PRNewswire/ -- Prestige Biopharma 今天宣布了其 III 期 SAMSON-II 研究的积极顶线结果，该研究评估了 HD204（一种拟议的 Avastin 生物类似药）

®

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(bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).

成人晚期非鳞状非小细胞肺癌（NSCLC）患者中的（贝伐珠单抗）。

SAMSON-II is a randomized, double blind, parallel group, multicenter Phase 3 study conducted in 625 patients across 91 centers in 15 countries. Patients were randomized in a 1:1 ratio to receive HD204 or Avastin in combination with standard chemotherapy.

SAMSON-II 是一项随机、双盲、平行组、多中心的三期研究，在15个国家的91个中心共纳入625名患者。患者以1:1的比例随机接受HD204或阿瓦斯汀联合标准化疗。

The study met its primary endpoint of overall response rate (ORR) at Week 18, demonstrating clinical equivalence between HD204 and Avastin within the prespecified equivalence margin. ORR at Week 18 was 48.7% in the HD204 arm compared with 46.5% in the Avastin arm. The risk ratio was 1.047 (95% confidence interval [CI]: 0.86–1.27), and the risk difference was 0.022 (95% CI: −0.07–0.11), with both estimates falling within the predefined equivalence range..

该研究在第18周达到了其总体缓解率（ORR）的主要终点，证明了HD204与阿瓦斯汀在预设的等效范围内具有临床等效性。HD204组在第18周的ORR为48.7%，而阿瓦斯汀组为46.5%。风险比为1.047（95%置信区间[CI]：0.86–1.27），风险差异为0.022（95% CI：−0.07–0.11），两项指标均落在预设的等效范围内。

Secondary efficacy endpoints were supportive of the primary analysis. Comparable overall response rates were observed at Week 12, and time-to-event outcomes demonstrated similar progression-free survival (PFS) and overall survival (OS) between treatment groups, with no statistically significant differences identified..

次要疗效终点支持主要分析。在第12周观察到相似的总体缓解率，时间至事件结局显示治疗组之间的无进展生存期（PFS）和总生存期（OS）相似，未发现统计学上的显著差异。

HD204 demonstrated a safety and tolerability profile consistent with the established safety experience of bevacizumab. Treatment-related adverse events were reported in 33.9% of patients receiving HD204 and 34.4% of patients receiving Avastin, while treatment-related serious adverse events occurred in 5.2% and 8.3% of patients, respectively.

HD204 表现出与贝伐单抗已知的安全性经验相符的安全性和耐受性特征。在接受 HD204 的患者中，33.9% 报告了治疗相关的不良事件，而在接受 Avastin 的患者中，这一比例为 34.4%；同时，分别有 5.2% 和 8.3% 的患者发生了治疗相关的严重不良事件。

No new or unexpected safety signals were identified..

未发现新的或意外的安全信号。

The clinical outcomes observed in SAMSON-II were consistent with the high degree of analytical and clinical pharmacokinetic (PK) similarity demonstrated between HD204 and Avastin. SAMSON-II results strengthen the collective global experience showing that sensitive analytical characterization and comparative clinical PK studies can reliably predict equivalent clinical performance in biosimilar development.

SAMSON-II 中观察到的临床结果与 HD204 和 Avastin 之间展示的高度分析和临床药代动力学 (PK) 相似性一致。SAMSON-II 的结果加强了全球经验的累积，表明在生物类似药开发中，敏感的分析特性和比较性临床 PK 研究可以可靠地预测等效的临床表现。

Prestige Biopharma is advancing regulatory pathways for HD204 based on the strong analytical and clinical PK programs, while sharing the SAMSON-II findings to further contribute to the global scientific experience in biosimilar evaluation..

Prestige Biopharma 正在基于强大的分析和临床药代动力学项目推进 HD204 的监管路径，同时分享 SAMSON-II 的研究结果，以进一步为全球生物类似药评估的科学经验做出贡献。

'These results illustrate the increasing precision with which biosimilarity can be established through advanced analytical and clinical PK studies,' said Dr. Lisa Park, Chief Executive Officer of Prestige Biopharma. 'Our experience with HD204 supports the view that well-designed development programs can reliably anticipate clinical performance, enabling more focused and efficient biosimilar development.

“这些结果表明，通过先进的分析和临床药代动力学研究，可以越来越精确地确定生物相似性，”Prestige Biopharma首席执行官Lisa Park博士表示。“我们在HD204方面的经验支持了这一观点，即精心设计的开发计划能够可靠地预测临床表现，从而实现更加集中和高效的生物类似药开发。”

By reducing unnecessary clinical burden, such advances can accelerate patient access to high-quality biologic medicines and support more sustainable healthcare systems worldwide.'.

通过减少不必要的临床负担，这些进展可以加速患者获得高质量的生物药物，并支持全球更可持续的医疗保健系统。

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