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March 22, 2026

2026年3月22日

Amplia Therapeutics Limited

安普利亚治疗有限公司

(ASX: ATX)

（澳大利亚证券交易所代码：ATX）

, (“Amplia” or the “Company”), announces mature data from the ongoing ACCENT clinical trial in advanced pancreatic cancer in which the Company’s lead drug narmafotinib is combined with chemotherapy showing a median overall survival of 11.1 months, and five complete responses recorded to date.

（“Amplia”或“公司”）宣布了正在进行的ACCENT临床试验的成熟数据，该试验针对晚期胰腺癌，公司的主要药物narmafotinib与化疗联合使用，显示出11.1个月的中位总生存期，并且迄今为止已记录了五例完全缓解。

HIGHLIGHTS

亮点

Formal centralised and independent analysis of the clinical response data from the ACCENT trial has been undertaken and updated analysis provided to the Company

已对ACCENT试验的临床反应数据进行了正式的集中和独立分析，并向公司提供了更新的分析结果。

The data confirm that five (5) patients have achieved a complete response (CR) in the Phase 1b/2a trial of narmafotinib combined with chemotherapy resulting in an unprecedented rate of CRs of 7.8% (5/C4)

数据证实，在narmafotinib联合化疗的1b/2a期试验中，已有五名（5）患者达到了完全缓解（CR），完全缓解率（CRs）达到了前所未有的7.8%（5/64）。

A median Overall Survival of 11.1 months has also been determined which is a 2 month improvement compared to chemotherapy alone, with no additional toxicity burden

中位总生存期为11.1个月，与单独化疗相比延长了2个月，且没有增加额外的毒性负担。

The Company has been chosen to present trial data at the prestigious annual meeting of the American Association of Cancer Research (AACR) being held in April 202C in San Diego, CA, USA

公司已被选中在202C年4月于美国加利福尼亚州圣地亚哥举行的美国癌症研究协会（AACR）年度盛会上展示试验数据。

Expert central reading of the clinical data by a contracted independent laboratory has reclassified some of the response data, identifying an additional four (4) confirmed complete responses (CRs). This brings the total CR’s for all patients in the ACCENT trial receiving a 400 mg dose of narmafotinib to five (5), resulting in a CR rate of 7.8% (5/64) which is unprecedented in this indication.

由签约的独立实验室对临床数据进行专家集中解读后，重新分类了部分反应数据，确认了另外四例完全缓解（CR）。这使得ACCENT试验中所有接受400毫克剂量Narmafotinib治疗的患者的总CR数达到五例（5），完全缓解率达到7.8%（5/64），在该适应症中前所未有。

Notably, this does not include the pathological complete response (pCR) recorded in the ACCENT trial, announced in June 2025. A confirmed CR means that CT scans have confirmed the disappearance of measurable tumours and metastases for two months or more, without the appearance of new lesions..

值得注意的是，这并不包括2025年6月公布的ACCENT试验中记录的病理完全缓解（pCR）。确认的完全缓解意味着CT扫描已证实可测量的肿瘤和转移灶消失两个月或更久，且没有新病灶出现。

An additional confirmed partial response (PR) has also been identified, resulting in an updated Objective Response Rate (ORR) of 35.9% (23/64) for all patients in both stages of the 1b/2a ACCENT trial on a 400 mg dose of narmafotinib. As of 15 March 2026, four (4) patients remain on study, with one patient approaching 24 months on trial..

还确认了另一例部分缓解 (PR)，使得在 400 毫克剂量的 narmafotinib 下，1b/2a 期 ACCENT 试验两个阶段中所有患者的客观缓解率 (ORR) 更新为 35.9%（23/64）。截至 2026 年 3 月 15 日，仍有四名患者在继续参与研究，其中一名患者即将完成 24 个月的试验。

Up until the independent analysis, all clinical response data reported to the market has been based on analysis by the clinical investigator at each trial site. The Company has always planned for an independent data analysis to occur toward the conclusion of the trial, and with the anticipated completion in Ǫ3 2026 this analysis was recently initiated.

直到独立分析之前，所有向市场报告的临床反应数据都基于每个试验地点的临床研究者的分析。公司一直计划在试验接近尾声时进行独立的数据分析，并且随着预计在2026年第三季度完成，这一分析最近已经启动。

The expert and independent ‘central read’ laboratory has used the standardized and internationally recognized RECIST 1.1 criteria for measuring how a patient’s cancer responds to treatment. .

专家和独立的“中心读取”实验室使用了标准化和国际认可的RECIST 1.1标准来衡量患者癌症对治疗的反应。

Importantly, analysis of overall survival data (with a data cut-off of mid-March), indicates a median Overall Survival (mOS) of 11.1 months. This is an approximate two-month improvement when compared to clinical studies of the gemcitabine-Abraxane® chemotherapy alone, including the MPACT study

重要的是，对总生存期数据（数据截止至三月中旬）的分析显示，中位总生存期 (mOS) 为 11.1 个月。与单独使用吉西他滨-Abraxane® 化疗的临床研究（包括 MPACT 研究）相比，这大约提高了两个月。

1

1

, which established this standard-of-care for advanced pancreatic cancer and against which ACCENT is benchmarked.

，该标准确立了晚期胰腺癌的护理标准，ACCENT 也是以此为基准进行衡量的。

Combined, these data compare very favourably to published data for the gemcitabine-Abraxane chemotherapy alone from both the historical MPACT trial1 and the recent NAPOLI 3 trial

这些数据综合起来，与历史上的 MPACT 试验1和近期的 NAPOLI 3 试验中单独使用吉西他滨-白蛋白紫杉醇化疗的已公布数据相比，非常有利。

2

2

(see table). Particularly noteworthy is that the mOS data from the ACCENT trial is identical to that obtained for the combination chemotherapy regimen NALIRIFOX in NAPOLI 3, and which resulted in its subsequent approval by the US FDA.

（见表）。特别值得注意的是，ACCENT试验的mOS数据与NAPOLI 3中获得的NALIRIFOX联合化疗方案的数据相同，这也导致了其随后获得美国FDA的批准。

Narmafotinib continues to be well tolerated by patients with the adverse effect profile of the narmafotinib- chemotherapy combination similar to chemotherapy alone.

纳马呋替尼继续被患者良好耐受，纳马呋替尼联合化疗的不良反应特征与单独化疗相似。

The Company has been selected to present its trial data, along with additional ACCENT data derived from further analysis of the independently read data, at the annual meeting of the American Association of Cancer Research (AACR) meeting to be held April 17-22 in San Diego, California.

公司已被选中在4月17日至22日于加利福尼亚州圣地亚哥举行的美国癌症研究协会（AACR）年会上展示其试验数据，以及从独立阅读数据的进一步分析中得出的更多ACCENT数据。

Dr Chris Burns, CEO and Managing Director of Amplia

克里斯·伯恩斯博士，Amplia首席执行官兼董事总经理

, commented on the latest results:

，对最新结果发表评论：

“These latest data from the ACCENT trial clearly demonstrate the significant clinical benefit of narmafotinib. The unprecedented 7.8% rate of CR's in the first line setting provides new hope for patients with this very aggressive cancer and provides further strong support for the benefit that narmafotinib can bring when combined with other treatment modalities.

“ACCENT试验的这些最新数据清楚地表明了纳尔马福替尼显著的临床益处。在一线治疗中达到前所未有的7.8%的完全缓解率，为患有这种极具侵袭性癌症的患者提供了新的希望，并进一步强有力地支持了纳尔马福替尼与其他治疗方式结合时带来的益处。”

We look forward to presenting a detailed analysis of the ACCENT trial at the forthcoming AACR conference.” .

我们期待在即将到来的AACR会议上对ACCENT试验进行详细分析。

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This article includes content from Amplia Therapeutics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer .

本文包含来自Amplia Therapeutics的内容，该内容已获授权在Investing News Australia上发布。本文不构成金融产品建议。在根据此处提供的任何信息采取行动之前，您有责任进行适当的尽职调查。请参阅我们的完整免责声明。

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