What's Going On With Mid-Cap Cancer-Focused Verastem Oncology Stock On Friday?
What's Going On With Mid-Cap Cancer-Focused Verastem Oncology Stock On Friday?
Thursday, Verastem Oncology (NASDAQ:VSTM) announced the initial interim safety and efficacy results from the ongoing RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the first-line in patients with metastatic pancreatic cancer.
周四，Verastem Oncology（纳斯达克股票代码：VSTM）公布了正在进行的RAMP 205 1/2期试验的初步中期安全性和有效性结果，该试验评估了阿伏托美替尼与吉西他滨和NAB-紫杉醇联合用于治疗转移性胰腺癌患者的一线。
The initial interim results will be presented at the upcoming American Society of Clinical Oncology Annual Meeting.
初步的中期结果将在即将举行的美国临床肿瘤学会年会上公布。
As of May 14, patients receiving the combination of avutometinib and defactinib with gemcitabine and Nab-paclitaxel in dose level 1 cohort achieved a confirmed overall response rate (ORR) of 83% (5/6).
截至5月14日，在剂量等级1的队列中接受阿伏托替尼和德法替尼联合使用吉西他滨和NAB-紫杉醇的患者的确诊总体缓解率（ORR）为83％（5/6）。
Of the 26 patients in all cohorts who have had the opportunity to have their first scan while on treatment, 21 have experienced a reduction of the change in target lesion sum of diameters.
在所有队列中有机会在治疗期间进行首次扫描的26名患者中，有21名患者的目标病变直径总和的变化有所减少。
One dose-limiting toxicity, febrile neutropenia (low white blood cell count), was observed in the dose level 1 cohort. The cohort was cleared after additional patients were evaluated.
在剂量等级 1 的队列中观察到一种剂量限制性毒性，即发热性中性粒细胞减少（低白细胞数）。在对更多患者进行评估后，该队列被清除。
In the additional dose cohorts enrolled more recently (-1, 1a, and 2a), follow-up is ongoing, and most patients remained on treatment at the data cutoff.
在最近加入的额外剂量群组（-1、1a和2a）中，随访仍在进行中，大多数患者在数据截止时仍在接受治疗。
Verastem Oncology has established clinical collaborations with Amgen Inc (NASDAQ:AMGN) and Bristol-Myers Squibb Co (NYSE:BMY) Mirati to evaluate Lumakras (sotorasib) in combination with avutometinib and defactinib and Krazati (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the Phase 1b/2 RAMP 203 and RAMP 204 trials, respectively.
Verastem Oncology已与安进公司（纳斯达克股票代码：AMGN）和百时美施贵宝公司（纽约证券交易所代码：BMY）Mirati建立了临床合作，评估Lumakras（sotorasib）与阿伏托美替尼联合使用阿伏托美替尼在KRAS G12C突变体非小细胞肺癌中的组合以及KRAS G12C突变体非小细胞肺癌中的Krazati（阿达格拉辛）联合阿伏托美替尼分别是 1b/2 期 RAMP 203 和 RAMP 204 试验。
Friday, Verastem Oncology initiated the rolling submission of a New Drug Application (NDA) to the FDA seeking accelerated approval of the combination of avutometinib and defactinib for adult patients with recurrent KRAS mutant (KRAS mt) low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy.
周五，Verastem Oncology开始向美国食品药品管理局滚动提交新药申请（NDA），寻求加快批准阿伏托美替尼和德法替尼的联合用药，用于复发性KRAS突变体（KRAS mt）低度浆液性卵巢癌（LGSOC）的成年患者，他们之前至少接受过一次全身治疗。
FDA has accepted Verastem's plan to submit the clinical module in the second half of 2024 to complete the NDA application.
美国食品药品管理局已经接受了Verastem的计划，即在2024年下半年提交临床模块以完成保密协议的申请。
The company plans to request a priority review of the NDA. Currently, there are no FDA-approved treatments specifically for recurrent LGSOC.
该公司计划要求对保密协议进行优先审查。目前，没有经美国食品药品管理局批准的专门针对复发性LGSOC的治疗方法。
The company is currently enrolling patients and activating sites for RAMP 301, an international confirmatory Phase 3 trial, evaluating the avutometinib and defactinib combination versus standard of care chemotherapy or hormonal therapy for KRAS mt and KRAS wt recurrent LGSOC.
该公司目前正在招募患者并激活RAMP 301，这是一项国际确认性3期试验，旨在评估复发性LGSOC时阿伏托美替尼和德非替尼组合对KRAS mt和KRAS的标准护理化疗或激素疗法的对比。
Price Action: VSTM shares are down 59% at $4.99 during the premarket session at last check Friday after it surged as high as $19.74.
价格走势：VSTM股价在周五最后一次盘前交易时段下跌59％，至4.99美元，此前股价飙升至19.74美元。
Photo by Aunt Spray via Shutterstock
由 Aunt Spray 通过 Shutterstock 拍摄的照片
译文内容由第三方软件翻译。