SAN DIEGO, Oct. 17, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.®  (NASDAQ: MRTX), a commercial stage biotechnology company, today announced updated results from the KRYSTAL-7 Phase 2 study evaluating adagrasib combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation at the European Society of Medical Oncology Congress (ESMO) 2023.

圣地亚哥，2023年10月17日/PRNewswire/-Mirati Therapeutics，Inc.®（纳斯达克股票代码：MRTX），一家商业阶段生物技术公司，今天宣布了KRYSTAL-7第二阶段研究评估adagrasib联合pembrolizumab的最新结果。在欧洲医学肿瘤学会（ESMO）2023年会议上，患者用于治疗携带KRASG12C突变的一线NSCLC。

These data demonstrate a manageable safety profile and early signs of durability of adagrasib in combination with a checkpoint inhibitor in the first-line NSCLC setting..

这些数据表明，在一线NSCLC环境中，adagrasib联合检查点抑制剂具有可控的安全性和早期耐久性迹象。。

Summary of Clinical Results

临床结果总结

In patients with PD-L1 TPS ≥50%, adagrasib and pembrolizumab demonstrated an overall response rate (ORR) of 63% and disease control rate (DCR) of 84% and promising early signs of durability. The 63% confirmed response rate compares favorably to pembrolizumab monotherapy which has demonstrated an ORR of 39-45%.1,2.

在PD-L1TPS≥50%的患者中，adagrasib和pembrolizumab的总有效率（ORR）为63%，疾病控制率（DCR）为84%，并且具有良好的耐久性早期迹象。63%的确诊反应率优于pembrolizumab单药治疗，其ORR为39-45%.1,2。

A median progression free survival has not been reached at 10.1 months median follow up.

中位随访10.1个月未达到中位无进展生存期。

The safety profile of the adagrasib and pembrolizumab combination was consistent with either agent as monotherapy, with a low rate of treatment related adverse events (TRAEs) leading to discontinuation of both drugs in only 4% of patients.

adagrasib和pembrolizumab组合的安全性与任一药物作为单一疗法一致，治疗相关不良事件（TRAEs）发生率低，导致仅4%的患者停用两种药物。

Treatment related hepatic events occurred in <10% of patients and were predominantly low grade. No patients discontinued both adagrasib and pembrolizumab due to ALT/AST increase or hepatic-related TRAEs.

治疗相关的肝脏事件发生在<10%的患者中，并且主要是低级别的。由于ALT/AST增加或肝脏相关的TRAEs，没有患者停用adagrasib和pembrolizumab。

'Data presented to date indicate that adagrasib prescribed following or in combination with immunotherapy offers a tolerable safety regimen for first-line NSCLC patients with a KRASG12C mutation,' said Marina C. Garassino, M.D., professor of medicine, UChicago Medicine. 'Adagrasib is the only KRASG12C inhibitor to be feasibly combined concurrently or following immunotherapy with a well-managed hepatoxicity profile, and still exhibits positive efficacy signals.'.

医学博士Marina C.Garassino博士，UChicago medicine医学教授说：“迄今为止提供的数据表明，在免疫疗法之后或与免疫疗法联合使用的adagrasib为具有KRASG12C突变的一线NSCLC患者提供了可耐受的安全方案。”Adagrasib是唯一可以同时或在免疫治疗后与良好管理的肝毒性特征相结合的KRASG12C抑制剂，并且仍然表现出积极的疗效信号。

'We are pleased to see these significant findings, which further support the initiation of a global Phase 3 study evaluating the combination of adagrasib plus immunotherapy in the first-line setting for KRASG12C-mutated NSCLC with PD-L1 TPS ≥50% for the benefit of patients,' said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics.

“我们很高兴看到这些重要的发现，这进一步支持了一项全球3期研究的启动，该研究评估了在KRASG12C突变NSCLC的一线治疗中联合使用adagrasib加免疫治疗与PD-L1TPS≥50%的益处患者，“Mirati Therapeutics首席医官Alan Sandler博士说。

'Potential combinability with an immunotherapy, in addition to encouraging clinical activity in other tumor types and demonstrated central nervous system (CNS) penetration, reinforces our confidence in the differentiation of adagrasib from other potential treatment options and the benefit it offers to patients.'.

“与免疫疗法的潜在可组合性，除了鼓励其他肿瘤类型的临床活动并证明中枢神经系统（CNS）渗透外，增强了我们对adagrasib与其他潜在治疗方案的区别及其为患者提供的益处的信心。”。

Mirati plans to initiate a Phase 3 clinical study to evaluate adagrasib in combination with pembrolizumab in the first line setting for KRASG12C-mutated NSCLC with PD-L1 TPS ≥50%. Initial patient enrollment is expected by year-end 2023.

Mirati计划启动一项3期临床研究，以评估adagrasib联合pembrolizumab治疗KRASG12C突变NSCLC的一线治疗，PD-L1TPS≥50%。预计到2023年底患者首次入组。

About Mirati Therapeutics, Inc.®Mirati Therapeutics, Inc. is a commercial stage research and development biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer.

关于Mirati Therapeutics，Inc.®MiratiTherapeutics，Inc。是一家商业阶段研发生物技术公司，其使命是发现，设计和提供突破性疗法，以改变癌症患者及其亲人的生活。该公司不懈地致力于提出解决包括肺癌在内的高度未满足需求领域的治疗方法，并推进针对癌症遗传和免疫驱动因素的新型治疗方法。

Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.For more information about Mirati, visit us at Mirati.com or follow us on Twitter, LinkedIn and Facebook.  .

Mirati的愿景是为患者统一，旨在解开超越癌症的生命承诺背后的科学。有关Mirati的更多信息，请访问Mirati.com或在Twitter，LinkedIn和Facebook上关注我们。  .

Forward Looking StatementsThis press release includes forward-looking statements regarding Mirati's business, financial guidance and the therapeutic and commercial potential of KRAZATI® (adagrasib), MRTX1719 (MTA-cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and MRTX1133 (selective KRASG12D inhibitor), Mirati's technologies and Mirati's other products in development.

前瞻性声明本新闻稿包括有关Mirati业务，财务指导以及KRAZATI®（adagrasib），MRTX1719（MTA合作PRMT5抑制剂），MRTX0902（SOS1抑制剂）和MRTX1133（选择性KRASG12D抑制剂）的治疗和商业潜力的前瞻性声明。），Mirati的技术和Mirati正在开发的其他产品。

Any statement describing Mirati's goals, expectations, intentions or beliefs, financial or other projections, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines..

任何描述Mirati的目标，期望，意图或信念，财务或其他预测的声明都是前瞻性声明，应被视为风险声明。这些陈述受到某些风险和不确定性的影响，包括在发现，开发和商业化可用作人类治疗药物的药物过程中固有的风险和不确定性，以及努力在这些药物周围建立业务。。

Mirati's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Mirati's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Mirati.

Mirati的前瞻性陈述还涉及假设，如果它们从未实现或证明正确，可能会导致其结果与此类前瞻性陈述所表达或暗示的结果大不相同。虽然Mirati的前瞻性陈述反映了其管理层的善意判断，但这些陈述仅基于Mirati目前已知的事实和因素。

As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Mirati's programs are described in additional detail in Mirati's annual report on Form 10-K, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission and available at the SEC's Internet site (www.sec.gov).

因此，警告您不要依赖这些前瞻性陈述。有关Mirati计划的这些和其他风险在Mirati的10-K表格年度报告和最新表格10-Q中有更详细的描述，这些表格已提交给证券交易委员会并可在SEC的互联网网站上查阅（www.SEC.gov）。

These forward-looking statements are made as of the date of this press release, and Mirati assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law..

这些前瞻性声明截至本新闻稿发布之日，Mirati不承担更新前瞻性声明或更新实际结果可能与前瞻性声明中预测结果不同的原因的义务，除非法律要求。。

Mirati ContactsInvestor Relations: [email protected]Media Relations: [email protected]

Mirati ContactsInvestor关系：[电子邮件保护]媒体关系：[电子邮件保护]

References

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Reck M, et al. N Engl J Med 2016;375:1823–1833

Reck M，et al.N Engl J Med 2016；375:1823–1833

SOURCE Mirati Therapeutics, Inc.

来源Mirati Therapeutics，Inc。