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What's Going On With Cardiff Oncology Stock On Tuesday?

What's Going On With Cardiff Oncology Stock On Tuesday?

周二,Cardiff Oncology 股票发生了什么?
Benzinga ·  2024/12/10 07:16

On Tuesday, Cardiff Oncology, Inc. (NASDAQ:CRDF) revealed initial data from the CRDF-004 Phase 2 trial, which evaluates onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).

在周二,Cardiff Oncology, Inc. (纳斯达克:CRDF) 公布了来自 CRDF-004 II 期试验的初步数据,该试验评估了 onvansertib 联合标准治疗 (SoC) 在一线 RAS 突变的转移性结直肠癌 (mCRC) 患者中的效果。

The CRDF-004 phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation.

CRDF-004 II 期试验目前正在招募有记录的 KRAS 或 NRAS 突变的 mCRC 患者。

Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Patients are being randomized in a 1:1:1 ratio to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.

onvansertib 加入了由 FOLFIRI 加上贝伐单抗或 FOLFOX 加上贝伐单抗组成的 SoC。患者被随机分配到 20mg 的 onvansertib 加 SoC、30mg 的 onvansertib 加 SoC 或仅 SoC 的比例为 1:1:1。

Efficacy and safety data are for all evaluable patients as of November 26.

截至 11 月 26 日的有效患者的疗效和安全性数据。

An objective response rate of 57% was observed in all onvansertib patients, with 50% in the 20mg dose of onvansertib + SoC arm and 64% in the 30mg dose of onvansertib + SoC arm, compared to 33% in the SoC alone arm.

在所有接受 onvansertib 的患者中观察到 57% 的客观反应率,其中 20mg onvansertib + SoC 组为 50%,30mg onvansertib + SoC 组为 64%,而仅 SoC 组为 33%。

Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses observed in patients receiving the 30mg dose of onvansertib combined with the SoC compared to the control arms and 20mg dose of onvansertib arms.

蜘蛛图显示了每个患者肿瘤大小从基线到现在的变化,表明接受 30mg onvansertib 联合 SoC 的患者比对照组和 20mg onvansertib 组观察到了更深入的反应。

Onvansertib, in combination with chemo/bevacizumab, was well-tolerated, and no major or unexpected toxicities were observed.

onvansertib 与化疗/贝伐单抗联合使用耐受良好,没有观察到严重或意外的毒性。

Additional clinical data from the CRDF-004 trial is expected in 1H 2025.

预计将于 2025 年上半年获得来自 CRDF-004 试验的额外临床数据。

"We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial," said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology.

“我们对在我们的随机一线RAS突变mCRC CRDF-004试验中,前30例可评估患者观察到的onvansertib加标准治疗的强效应信号和良好的安全性表现感到非常鼓舞,”卡迪夫肿瘤学的首席医疗官Fairooz Kabbinavar博士表示。

"Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses."

“我们的数据表明,在接受30毫克onvansertib与标准治疗联合治疗的患者中,客观反应率为64%,显著高于仅接受标准治疗的对照组的33%客观反应率。此外,从蜘蛛图中可以看出,接受30毫克onvansertib的患者与接受20毫克剂量的患者相比,肿瘤反应更为明显,而两种剂量的安全性谱都相似。”

Price Action: CRDF stock was trading 52% higher to $3.71 at the last check on Tuesday.

价格动态:在周二的最后检查中,CRDF股票交易价格上涨52%至3.71美元。

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