Revolution Medicines, Inc. a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for previously treated metastatic PDAC in patients with KRAS G12 mutations..

Revolution Medicines, Inc.是一家专注于开发针对RAS依赖型癌症患者的靶向疗法的晚期临床肿瘤学公司，今日宣布美国食品药品监督管理局（FDA）已授予daraxonrasib突破性疗法认定。Daraxonrasib是该公司的RAS(ON)多选择性抑制剂，用于治疗先前接受过治疗的携带KRAS G12突变的转移性胰腺导管腺癌（PDAC）患者。

The Breakthrough Therapy Designation is based on encouraging data from the Phase 1 RMC-6236-001 clinical trial evaluating daraxonrasib in patients with previously treated metastatic PDAC.

突破性疗法指定是基于一期RMC-6236-001临床试验的鼓舞人心的数据，该试验评估了daraxonrasib在先前治疗过的转移性胰腺导管腺癌（PDAC）患者中的应用。

“This Breakthrough Therapy Designation underscores the enormous need for new treatments for patients with pancreatic cancer and highlights the potentially important role the investigational drug, daraxonrasib, may have in helping patients living with this disease,” said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

“这项突破性疗法认定强调了胰腺癌患者对新疗法的巨大需求，并突显了在研药物daraxonrasib在帮助该疾病患者方面可能发挥的重要作用，”Revolution Medicines首席执行官兼董事长Mark A. Goldsmith医学博士表示。

“We look forward to substantially completing enrollment of the RASolute 302 study this year to enable an expected readout in 2026, and should the results support it, working closely with the FDA and other regulatory agencies around the world to bring daraxonrasib to patients as quickly as possible.”.

“我们期待在今年大幅完成RASolute 302研究的入组工作，以便在2026年获得预期数据，并在结果支持的情况下，与FDA及全球其他监管机构紧密合作，尽快将daraxonrasib带给患者。”

Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions and address significant unmet medical needs. The medicine needs to have shown encouraging preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines..

breakthrough therapy designation旨在加速潜在新药的研发和审评，这些药物用于治疗严重疾病并满足显著未被满足的医疗需求。该药物需展示出令人鼓舞的初步临床证据，证明其在临床上的重要终点上较现有药物有显著改善。

More than 90% of patients living with PDAC have tumors carrying a RAS cancer driver mutation with ~85% carrying a KRAS G12 mutation. Revolution Medicines is currently enrolling patients in RASolute 302, a global Phase 3 registrational study of daraxonrasib in patients with previously treated metastatic PDAC.

超过90%的胰腺导管腺癌（PDAC）患者携带RAS致癌驱动突变，其中约85%携带KRAS G12突变。Revolution Medicines目前正在招募患者参与RASolute 302研究，这是一项针对既往接受过治疗的转移性PDAC患者中使用daraxonrasib的全球III期注册研究。

The study design focuses on a core population of patients with PDAC harboring RAS mutations at position 12 (RAS G12X) and an expanded population that includes patients with tumors harboring RAS mutations at position G12 (RAS G12X), G13 (RAS G13X) or Q61 (RAS Q61X), or those without any identified targetable mutation.

研究设计聚焦于携带第12位RAS突变（RAS G12X）的PDAC患者的核心人群，以及包含携带第G12位（RAS G12X）、G13位（RAS G13X）或Q61位（RAS Q61X）RAS突变肿瘤的患者，或那些未发现任何可靶向突变的患者的扩展人群。

The dual primary endpoints for the study are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS and OS in the expanded population of patients. Additional information about RASolute 302 (NCT06625320) is available at clinicaltrials.gov..

该研究的双重主要终点是核心患者群体中的无进展生存期（PFS）和总生存期（OS）。关键的次要终点包括扩展患者群体中的无进展生存期（PFS）和总生存期（OS）。有关RASolute 302（NCT06625320）的更多信息，请访问clinicaltrials.gov。

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma

关于胰腺癌和胰腺导管腺癌

Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that in 2024, approximately 60,000 people will be diagnosed with pancreatic cancer1, and about 50,000 people will die from this aggressive disease..

胰腺癌是最致命的恶性肿瘤之一，通常在晚期才被诊断出来，对标准化疗具有耐药性，并且死亡率很高。在美国，最近的估计表明，2024年将有大约60,000人被诊断出患有胰腺癌，约50,000人将死于这种侵袭性疾病。

The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, accounts for approximately 92% of all pancreatic cancer cases2. Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage.

最常见的胰腺癌形式，胰腺导管腺癌 (PDAC) 及其变体，约占所有胰腺癌病例的 92%。由于缺乏早期症状和检测方法，大约 80% 的患者在晚期或转移阶段被诊断出患有 PDAC。

It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations3. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%4..

它是所有主要癌症中最常与RAS成瘾相关的，超过90%的患者肿瘤存在RAS突变。转移性PDAC仍然是美国癌症相关死亡的最常见原因之一，五年生存率约为3%。

About Daraxonrasib

关于达拉克松拉斯布

Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC)..

达拉克松尼（RMC-6236）是一种口服的、直接作用的RAS(ON)多选择性抑制剂，具有帮助应对由致癌RAS突变驱动的多种癌症的潜力。达拉克松尼通过阻断RAS(ON)与其下游效应因子的相互作用来抑制RAS信号传导。它通过靶向常见的主要致癌RAS突变G12X、G13X和Q61X，这些突变是包括胰腺导管腺癌（PDAC）、非小细胞肺癌（NSCLC）和结直肠癌（CRC）在内的主要癌症的常见驱动因素。

About Revolution Medicines, Inc.

关于Revolution Medicines公司

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development.

Revolution Medicines是一家处于后期临床阶段的肿瘤学公司，致力于为RAS成瘾型癌症患者开发新型靶向疗法。公司的研发管线包括旨在抑制多种RAS蛋白致癌变异体的RAS(ON)抑制剂。其RAS(ON)抑制剂daraxonrasib（RMC-6236），一种RAS(ON)多选择性抑制剂；elironrasib（RMC-6291），一种RAS(ON) G12C选择性抑制剂；以及zoldonrasib（RMC-9805），一种RAS(ON) G12D选择性抑制剂，目前均处于临床开发阶段。

The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn..

该公司预计，RMC-5127 是一种 RAS(ON) G12V 选择性抑制剂，将是其下一个进入临床开发的 RAS(ON) 抑制剂。公司研发管线中的其他开发机会聚焦于 RAS(ON) 突变选择性抑制剂，包括 RMC-0708（Q61H）和 RMC-8839（G13C）。欲了解更多信息，请访问 www.revmed.com 并在 LinkedIn 上关注我们。