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.
週四，Verastem Oncology（納斯達克股票代碼：VSTM）公佈了正在進行的RAMP 205 1/2期試驗的初步中期安全性和有效性結果，該試驗評估了阿伏託美替尼與吉西他濱和NAB-紫杉醇聯合用於治療轉移性胰腺癌患者的一線。
The initial interim results will be presented at the upcoming American Society of Clinical Oncology Annual Meeting.
初步的中期結果將在即將舉行的美國臨床腫瘤學會年會上公佈。
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，在劑量等級1的隊列中接受阿伏託替尼和德法替尼聯合使用吉西他濱和NAB-紫杉醇的患者的確診總體緩解率（ORR）爲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.
在所有隊列中有機會在治療期間進行首次掃描的26名患者中，有21名患者的目標病變直徑總和的變化有所減少。
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.
在劑量等級 1 的隊列中觀察到一種劑量限制性毒性，即發熱性中性粒細胞減少（低白細胞數）。在對更多患者進行評估後，該隊列被清除。
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.
在最近加入的額外劑量群組（-1、1a和2a）中，隨訪仍在進行中，大多數患者在數據截止時仍在接受治療。
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已與安進公司（納斯達克股票代碼：AMGN）和百時美施貴寶公司（紐約證券交易所代碼：BMY）Mirati建立了臨床合作，評估Lumakras（sotorasib）與阿伏託美替尼聯合使用阿伏託美替尼在KRAS G12C突變體非小細胞肺癌中的組合以及KRAS G12C突變體非小細胞肺癌中的Krazati（阿達格拉辛）聯合阿伏託美替尼分別是 1b/2 期 RAMP 203 和 RAMP 204 試驗。
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.
週五，Verastem Oncology開始向美國食品藥品管理局滾動提交新藥申請（NDA），尋求加快批准阿伏託美替尼和德法替尼的聯合用藥，用於複發性KRAS突變體（KRAS mt）低度漿液性卵巢癌（LGSOC）的成年患者，他們之前至少接受過一次全身治療。
FDA has accepted Verastem's plan to submit the clinical module in the second half of 2024 to complete the NDA application.
美國食品藥品管理局已經接受了Verastem的計劃，即在2024年下半年提交臨床模塊以完成保密協議的申請。
The company plans to request a priority review of the NDA. Currently, there are no FDA-approved treatments specifically for recurrent LGSOC.
該公司計劃要求對保密協議進行優先審查。目前，沒有經美國食品藥品管理局批准的專門針對複發性LGSOC的治療方法。
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.
該公司目前正在招募患者並激活RAMP 301，這是一項國際確認性3期試驗，旨在評估複發性LGSOC時阿伏託美替尼和德非替尼組合對KRAS mt和KRAS的標準護理化療或激素療法的對比。
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.
價格走勢：VSTM股價在週五最後一次盤前交易時段下跌59％，至4.99美元，此前股價飆升至19.74美元。
Photo by Aunt Spray via Shutterstock
由 Aunt Spray 通過 Shutterstock 拍攝的照片
譯文內容由第三人軟體翻譯。