EN
登录

抗肿瘤药物研发商Revolution Medicines泛RAS抑制剂治疗胰腺癌1b期结果积极,将进入3期临床

Positive Data in Pancreatic Cancer Pave Way for Pivotal Test of Revolution Medicines Drug

MedCity News 等信源发布 2024-07-16 05:45

可切换为仅中文


Pancreatic cancer remains one of the toughest cancers to treat, but Revolution Medicines has data from an early-stage study showing its experimental treatment helped patients live longer without their disease worsening. With these encouraging results, Revolution said Monday it is preparing to proceed to a pivotal clinical trial enrolling patients with advanced cases of the most common type of pancreatic cancer..

胰腺癌仍然是最难治疗的癌症之一,但Revolution Medicines的一项早期研究数据显示,其实验性治疗有助于患者延长寿命,而疾病不会恶化。有了这些令人鼓舞的结果,Revolution周一表示,它正在准备进行一项关键的临床试验,招募患有最常见类型胰腺癌晚期病例的患者。。

Revolution develops therapies that target the RAS family of proteins, validated but elusive targets for cancer drug research. Mutations to these proteins lead to the uncontrolled cell growth that happens in a variety of cancers. The most advanced program from Redwood City, California-based Revolution is RMC-6236.

Revolution开发了针对RAS蛋白家族的疗法,这是癌症药物研究的有效但难以捉摸的目标。这些蛋白质的突变导致各种癌症中发生的不受控制的细胞生长。总部位于加利福尼亚州红木市的Revolution最先进的项目是RMC-6236。

This small molecule is being evaluated in a Phase 1/1b study enrolling patients with advanced RAS mutation-driven solid tumors, including pancreatic cancer..

这种小分子正在1/1b期研究中进行评估,该研究招募了晚期RAS突变驱动的实体瘤(包括胰腺癌)患者。。

Chemotherapy is the primary treatment for pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer. Of the approximately 60,000 new PDAC cases annually, 92% are driven by RAS mutations, Revolution said in an investor presentation. The data reported Monday are from a group of 127 patients with PDAC who received RMC-6236 as a second line of therapy.

化疗是胰腺导管腺癌(PDAC)的主要治疗方法,PDAC是最常见的胰腺癌类型。Revolution在投资者介绍中表示,在每年约60000例新的PDAC病例中,92%是由RAS突变引起的。周一报道的数据来自127名接受RMC-6236作为第二线治疗的PDAC患者。

Revolution reported that treatment with its drug led to a median progression-free survival of 8.1 months in patients with KRAS G12 mutations. In patients with a broader range of RAS mutations, progression-free survival in this second-line setting was 7.6 months..

Revolution报道,用其药物治疗可使KRAS G12突变患者的中位无进展生存期为8.1个月。在RAS突变范围更广的患者中,这种二线治疗的无进展生存期为7.6个月。。

Revolution’s open label Phase 1/1b clinical trial did not have a chemotherapy arm so there is no head-to-head comparison with the standard of care. But the company said its review of publicly available results from clinical trials of chemotherapies for previously treated PDAC indicates that progression-free survival ranges from 2 months to 3.5 months.

Revolution的开放标签1/1b期临床试验没有化疗组,因此没有与标准护理进行头对头比较。但该公司表示,其对先前治疗的PDAC化疗临床试验公开结果的审查表明,无进展生存期为2个月至3.5个月。

Treatment-related adverse events reported in the Revolution study include rash; stomatitis, which is redness and swelling in the mouth and lips; reduced appetite; diarrhea; and lower platelet counts. No patients discontinued the drug..

革命研究报告的治疗相关不良事件包括皮疹;口腔炎,即口腔和嘴唇发红和肿胀;食欲下降;腹泻;并降低血小板计数。没有患者停药。。

Revolution said it plans to start a Phase 3 study in PDAC later this year. The clinical trial will compare a once-daily 300 mg dose to the physician’s choice of chemotherapy as a second-line treatment for PDAC. The main goals will be measuring progression-free survival and overall survival.

Revolution表示,计划今年晚些时候在PDAC开始一项3期研究。该临床试验将比较每日一次的300毫克剂量与医生选择的化疗作为PDAC的二线治疗。主要目标将是测量无进展生存期和总生存期。

Amgen won the first FDA approval of a KRAS inhibitor, the KRAS G12C-targeting drug Lumakras. Bristol Myers Squibb markets Krazati, a drug that blocks the same target. The approvals of both drugs cover non-small cell lung cancer. Revolution is also developing RMC-6236 for this type of cancer. Another RAS protein, SHP-2, is the target of a BMS drug whose rights were acquired from BridgeBio Pharma.

安进公司首次获得FDA对KRAS抑制剂的批准,即靶向KRAS G12C的药物Lumakras。百时美施贵宝(Bristol-Myers Squibb)销售Krazati,一种阻断同一目标的药物。这两种药物的批准都涵盖了非小细胞肺癌。Revolution也在为这种类型的癌症开发RMC-6236。另一种RAS蛋白SHP-2是BMS药物的靶标,其权利是从BridgeBio Pharma获得的。

Meanwhile, Frontier Medicines has reached Phase 1/2 clinical testing with FMC-376, a small molecule intended to treat solid tumors carrying the KRAS G12C mutation..

同时,前沿药物已经用FMC-376进行了1/2期临床试验,FMC-376是一种小分子,旨在治疗携带KRAS G12C突变的实体瘤。。

In a note sent to investors Monday, Leerink Partners analyst Jonathan Chang wrote that Revolution is expected to release a data update for its lead program in NSCLC in the second half of this year. While the field of RAS drug development is competitive, Chang said Revolution’s update is an important step forward for the company’s technology platform..

Leerink Partners分析师乔纳森·张(JonathanChang)在周一发给投资者的一份报告中写道,Revolution预计将在今年下半年发布其非小细胞肺癌领先项目的数据更新。虽然RAS药物开发领域竞争激烈,但常说,革命的更新是该公司技术平台向前迈出的重要一步。。

Last year, Revolution acquired EQRx in an all-stock transaction largely to get its hands on EQRx’s $1 billion in cash. In a Monday regulatory filing, Revolution said it projects having enough capital to support the company into 2027.

去年,Revolution在全股票交易中收购了EQRx,主要是为了获得EQRx的10亿美元现金。在周一提交的监管文件中,Revolution表示,预计到2027年,它将拥有足够的资金支持该公司。