NEW YORK--(BUSINESS WIRE)--AnHeart Therapeutics (“AnHeart”), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced positive interim results from its global pivotal Phase 2 clinical trial, TRUST-II. Interim data from the trial showed taletrectinib, AnHeart’s investigational next-generation ROS1 inhibitor, shrank tumors (confirmed objective response rate, cORR, as assessed by an independent review committee, IRC) in 92% of patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who had not previously been treated with a ROS1 tyrosine kinase inhibitor (TKI naïve).

纽约-（商业热线）-AnHeart Therapeutics（“AnHeart”）是一家为癌症患者开发新型精确疗法的全球临床阶段生物制药公司，今天宣布其全球关键的2期临床试验取得积极的中期成果，TRUST-II。来自该试验的中期数据显示，92%的晚期ROS1阳性非小细胞肺癌患者中，taletrectinib是一种心脏研究的下一代ROS1抑制剂，可缩小肿瘤（经独立审查委员会IRC评估的确诊客观缓解率cORR）肺癌（NSCLC）以前没有接受过ROS1酪氨酸激酶抑制剂（TKI-naïve）的治疗。

Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated). Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain..

Taletrectinib缩小了57%先前接受过ROS1 TKI（TKI预处理）治疗的患者的肿瘤。Taletrectinib在已扩散至大脑的疾病患者亚组中也显示出强大的颅内活性。。

Median progression-free survival (IRC-assessed) was not reached for TKI naïve patients and was 11.7 months for TKI pre-treated patients, respectively. Taletrectinib was generally well tolerated, and its safety profile was consistent with previous trials. The most common treatment emergent adverse events (TEAEs) were increased liver enzymes and gastrointestinal-related adverse events, the majority of which were Grade 1 or Grade 2.

TKI初治患者未达到中位无进展生存期（IRC评估），TKI预治疗患者分别为11.7个月。Taletrectinib一般耐受性良好，其安全性与以前的试验一致。最常见的治疗紧急不良事件（TEAE）是肝酶和胃肠相关不良事件增加，其中大多数是1级或2级。

Incidence of neurological TEAEs were low; the most common was dizziness (13%), most of which was Grade 1..

神经TEAE发生率低；最常见的是头晕（13%），其中大部分是1级。。

“While people with other types of lung cancer have seen great advances, there has been limited progress for people with ROS1-positive NSCLC, which presents significant treatment challenges,” said Maurice Pérol, M.D., TRUST-II trial investigator and Head of Thoracic Oncology at Léon Bérard Cancer Center, Lyon, France.

法国里昂LéonBérard癌症中心TRUST-II试验研究员兼胸部肿瘤学负责人MauricePérol博士说：“虽然其他类型肺癌患者取得了很大进展，但ROS1阳性非小细胞肺癌患者的进展有限，这对治疗提出了重大挑战。”。

“These interim TRUST-II data represent a significant step forward in the pursuit of better treatment options. Taletrectinib’s overall profile suggests it has the potential to be the medicine people with ROS1-positive NSCLC have been waiting for.”.

“这些临时TRUST-II数据代表了寻求更好治疗方案的重要一步，Taletrectinib的总体概况表明它有可能成为ROS1阳性NSCLC患者一直在等待的药物。”。

“We now have consistent results from two Phase 2 trials with taletrectinib. In both trials, taletrectinib shrank tumors in almost every ROS1 TKI naïve person and more than half of people previously treated with a ROS1 TKI, and the responses were durable. Taletrectinib was well tolerated, which is extremely important as we work to extend the time people with advanced ROS1-positive NSCLC live without their disease getting worse,” said Jerry Wang, PhD, Chief Executive Officer of AnHeart.

“我们现在在使用taletrectinib的两项2期临床试验中得到了一致的结果，在这两项试验中，taletrectinib几乎在每个ROS1 TKI初治患者和超过一半以前用ROS1 TKI治疗的患者中缩小了肿瘤，并且反应持久，taletrectinib耐受性良好，这是非常重要的，因为我们努力延长晚期ROS1阳性非小细胞肺癌患者的生活时间AnHeart首席执行官Jerry Wang博士说：。

“We anticipate reporting final data from TRUST-II next year, and look forward to making continued progress in our efforts to positively impact the lives of people living with lung cancer.”.

“我们预计明年将报告TRUST-II的最终数据，并期待我们在积极影响肺癌患者生活的努力方面取得持续进展。”。

Results will be presented at the European Society of Medical Oncology Congress 2023 by Maurice Pérol, M.D., TRUST-II trial investigator and Head of Thoracic Oncology at Léon Bérard Cancer Center, Lyon, France on October 23, 2023 (abstract #1373P).

结果将于2023年10月23日在法国里昂LéonBérard癌症中心的TRUST-II试验研究员和胸部肿瘤学负责人MauricePérol在2023年欧洲医学肿瘤学会大会上发表（摘要＃1373P）。

Taletrectinib has been granted Breakthrough Therapy Designations for the treatment of advanced or metastatic ROS1-positive NSCLC by both the U.S. Food and Drug Administration and the China National Medical Products Administration (NMPA).

Taletrectinib已被美国食品药品监督管理局和中国国家医药产品管理局（NMPA）授予突破性治疗指定，用于治疗晚期或转移性ROS1阳性NSCLC。

About the TRUST-II Trial

关于TRUST-II试验

TRUST-II (NCT04919811) is a global pivotal, multicenter, single-arm, open-label, Phase 2 clinical trial evaluating taletrectinib as a monotherapy in approximately 154 patients with ROS1-positive NSCLC and other solid tumors. Patients received 600 mg of taletrectinib once-a-day. Cohorts 1 and 2 of the trial are intended to be registrational and are evaluating taletrectinib in ROS1-positive NSCLC patients who have either not previously been treated with a ROS1 TKI (TKI naïve, n=53), or who have previously been treated with one approved ROS1 TKI (crizotinib or entrectinib, n=46), respectively.

TRUST-II（NCT04919811）是一项全球性关键，多中心，单臂，开放标签的2期临床试验，评估了约154例ROS1阳性NSCLC和其他实体瘤患者中taletrectinib作为单一疗法的疗效。患者每天一次接受600mg taletrectinib。该试验的第1组和第2组旨在进行登记，并正在评估ROS1阳性NSCLC患者中的taletrectinib，这些患者之前未接受过ROS1 TKI治疗（TKI-naïve，n=53），或曾接受过治疗一个批准的ROS1 TKI（crizotinib或entrectinib，n=46）。

Cohorts 3 and 4 are exploratory and are evaluating taletrectinib in ROS1-positive NSCLC patients who have previously been treated with two or more ROS1 TKIs (n=35), or patients with ROS1-positive NSCLC or other ROS1-positive solid tumors who are ineligible for Cohorts 1 to 3 (n=20), respectively. Patients are being enrolled at sites in the United States, Canada, Europe and Asia..

第3组和第4组是探索性的，正在评估先前接受过两种或两种以上ROS1 TKI（n=35）治疗的ROS1阳性NSCLC患者，或ROS1阳性NSCLC或其他ROS1阳性实体瘤患者中的taletrectinib对于队列1至3（n=20）分别是不合格的。患者正在美国，加拿大，欧洲和亚洲的地点注册。。

Interim efficacy data for Cohorts 1 and 2 were reported from 46 patients who had approximately six months of follow-up at the data cut-off date of July 12, 2023.

在2023年7月12日的数据截止日期，对46名患者进行了大约6个月的随访，报告了第1组和第2组的中期疗效数据。

In ROS1 TKI naïve patients (n=25), 16% of whom had also previously received chemotherapy:

在ROS1 TKI初治患者（n=25）中，其中16%以前也接受过化疗：

92.0% of patients’ tumors shrank in response to taletrectinib treatment (cORR as assessed by IRC)

92.0%的患者肿瘤在接受taletrectinib治疗后萎缩（IRC评估为cORR）

Median duration of response and median progression-free survival were not reached

中位持续时间和中位无进展生存期未达到

At 12 months, 89.5% of patients who responded to taletrectinib treatment were still responding

在12个月时，89.5%对taletrectinib治疗有反应的患者仍然有反应

Taletrectinib shrank brain tumors in 80.0% of people whose cancer had spread to the brain (n=5; intracranial cORR as assessed by IRC)

Taletrectinib缩小了80.0%癌症扩散到大脑的人的脑肿瘤（n=5；IRC评估的颅内cORR）

In patients previously treated with one ROS1 TKI (n=21), 52% of whom had also previously received chemotherapy:

在先前接受过一种ROS1 TKI治疗的患者中（n=21），其中52%以前也接受过化疗：

57.1% of patients’ tumors shrank in response to taletrectinib treatment (cORR as assessed by IRC)

57.1%的患者肿瘤在接受taletrectinib治疗后萎缩（IRC评估为cORR）

Median duration of response was not reached

中位持续时间没有达到

At 12 months, 81.5% of patients who responded to taletrectinib were still responding

在12个月时，81.5%对taletrectinib有反应的患者仍然有反应

Median progression-free survival was 11.7 months

中位无进展生存期为11.7个月

Taletrectinib shrank brain tumors in 62.5% of people whose cancer had spread to the brain (n=8; intracranial cORR as assessed by IRC)

Taletrectinib缩小了62.5%癌症扩散到大脑的人的脑肿瘤（n=8；IRC评估的颅内cORR）

Interim safety data from TRUST-II (n=107) showed the majority of TEAEs were Grade 1 or Grade 2. The most common TEAEs were increased liver enzymes (increased alanine aminotransferase: 64%; increased aspartate aminotransferase: 63%), diarrhea (43%), and nausea (43%), the majority of which were Grade 1 or Grade 2.

TRUST-II（n=107）的临时安全性数据显示，大多数TEAE为1级或2级。最常见的TEAE是肝酶增加（丙氨酸转氨酶增加：64%；天冬氨酸转氨酶增加：63%），腹泻（43%）和恶心（43%），其中大部分是1级或2级。

Incidence of neurological TEAEs were low; the most common was dizziness (13%), most of which was Grade 1. Dose reductions and treatment discontinuations due to TEAEs were 34% and 2%, respectively. There were no treatment-related deaths..

神经TEAE发生率低；最常见的是头晕（13%），其中大部分是1级。由TEAE引起的剂量减少和治疗中断分别为34%和2%。没有与治疗有关的死亡。。

More detailed results from today’s presentation can be found on AnHeart’s website at https://www.anhearttherapeutics.com/publications/.

今天的演示文稿的更详细结果可以在AnHeart的网站上找到https://www.anhearttherapeutics.com/publications/.

For additional information about TRUST-II visit https://www.trust2study.com/.

有关TRUST-II访问的更多信息https://www.trust2study.com/.

About Taletrectinib

Taletrectinib

Taletrectinib is an oral, potent, brain penetrant, selective, next-generation potential best-in-class ROS1 inhibitor being evaluated for the treatment of ROS1-positive NSCLC.

Taletrectinib是一种口服，有效，脑渗透，选择性，下一代潜在的一流ROS1抑制剂，正在评估用于治疗ROS1阳性NSCLC。

AnHeart previously reported data from the Phase 2 TRUST-I trial (NCT04395677) evaluating taletrectinib in ROS1-positive NSCLC patients in China, which showed a cORR of 92.5% in ROS1 TKI naïve patients (n=67) and 52.6% in crizotinib pre-treated patients (n=38), respectively, as assessed by IRC. The majority of TEAEs were Grade 1 or Grade 2.

AnHeart先前报道了来自中国ROS1阳性NSCLC患者的评估taletrectinib的2期TRUST-I试验（NCT04395677）的数据，其显示ROS1 TKI初治患者（n=67）的cORR为92.5%，crizotinib为52.6%预处理的患者（n=38），分别由IRC评估。大多数TEAE是1级或2级。

A pooled analysis of TRUST-I and Phase 1 trials with taletrectinib showed median progression-free survival of 33.2 months and 11.8 months in ROS1 TKI naïve and crizotinib pre-treated patients, respectively..

使用taletrectinib的TRUST-I和1期临床试验的汇总分析显示，ROS1 TKI初治和crizotinib预处理患者的中位无进展生存期分别为33.2个月和11.8个月。。

About ROS1-positive NSCLC

关于ROS1阳性NSCLC

More than one million people are anticipated to be diagnosed with NSCLC, the most common form of lung cancer, in the United States, Europe, China and Japan in 2023. It is estimated that approximately 1-2% of people with NSCLC in western countries and approximately 3% in China are ROS1-positive, meaning more than 22,000 people will be diagnosed with ROS1-positive NSCLC in these regions in 2023.

预计到2023年，美国，欧洲，中国和日本将有超过100万人被诊断为最常见的肺癌形式NSCLC。据估计，西方国家约有1-2%的NSCLC患者和中国约3%的患者为ROS1阳性，这意味着2023年这些地区将有超过22000人被诊断为ROS1阳性的NSCLC。

There are two FDA approved first-generation TKIs for people with newly diagnosed advanced or metastatic ROS1-positive NSCLC and no FDA approved therapies for people whose ROS1-positive NSCLC has progressed following treatment with these medicines. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment..

对于新诊断的晚期或转移性ROS1阳性非小细胞肺癌患者，有两种FDA批准的第一代TKIs，对于使用这些药物治疗后ROS1阳性非小细胞肺癌进展的患者，没有FDA批准的治疗方法。新诊断为转移性ROS1阳性NSCLC的患者中，高达35%的患者肿瘤已扩散至脑部（脑转移瘤），初始治疗后癌症进展的患者增加高达55%。。

About AnHeart Therapeutics

关于无心脏疗法

AnHeart Therapeutics (“AnHeart”) is a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer. Our lead investigational therapy, taletrectinib, is a next-generation ROS1-inhibitor currently in pivotal Phase 2 trials for ROS1-positive non-small cell lung cancer (NSCLC).

AnHeart Therapeutics（“AnHeart”）是一家为癌症患者开发新型精确疗法的全球临床阶段生物制药公司。我们的主要研究疗法taletrectinib是下一代ROS1抑制剂，目前正处于ROS1阳性非小细胞肺癌（NSCLC）的关键2期临床试验中。

Taletrectinib has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration and the China National Medical Products Administration. AnHeart’s second investigational therapy, safusidenib, is a mIDH1-inhibitor being evaluated in a Phase 2 trial for IDH1-mutant glioma..

Taletrectinib已被美国食品药品监督管理局和中国国家医疗产品管理局授予突破性治疗名称。AnHeart的第二个研究性治疗safusidenib是一项mIDH1抑制剂，正在IDH1突变型胶质瘤的2期临床试验中进行评估。。

Our mission is to improve the lives of people with cancer. We are supported by leading life sciences investors and have built an organization with deep oncology drug discovery and development expertise, with offices in New York and Shanghai. For more information, visit https://www.anhearttherapeutics.com/ or follow us on LinkedIn at https://www.linkedin.com/company/anheart-therapeutics-official/..

我们的使命是改善癌症患者的生活。我们得到了领先的生命科学投资者的支持，并建立了一个拥有深度肿瘤药物发现和开发专业知识的组织，并在纽约和上海设有办事处。欲了解更多信息，请访问https://www.anhearttherapeutics.com/或者跟随我们在LinkedInhttps://www.linkedin.com/company/anheart-therapeutics-official/..