What's Going On With Cancer-Focused Tempest Therapeutics Stock On Thursday?
What's Going On With Cancer-Focused Tempest Therapeutics Stock On Thursday?
Shares of Tempest Therapeutics Inc (NASDAQ:TPST) are trading lower on Thursday, with a session volume of 21 million as per data from Benzinga Pro.
Tempest Therapeutics股票（納斯達克股票代碼：TPST）週四交易下跌，交易量爲2100萬股，數據來自Benzinga Pro。
The company announced new data from the ongoing Phase 1b/2 clinical study on amezalpat2 (TPST-1120).
該公司宣佈了有關amezalpat2（TPST-1120）進行中的1b/2期臨床研究的新數據。
The drug candidate delivered a six-month improvement in median overall survival advantage when combined with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
與單獨使用atezolizumab和bevacizumab相比，在無法手術切除或轉移的肝細胞癌（HCC，最常見的原發性肝癌類型）的一線治療中，該藥物候選組合物與atezolizumab和bevacizumab相結合，可使中位總體生存優勢提高六個月。
At the cutoff date of February 14, 2024, the new data from 40 patients randomized to the amezalpat arm and 30 patients randomized to the control arm show:
截至2024年2月14日，amezalpat組隨機分配的40名患者和對照組隨機分配的30名患者的新數據顯示：
- 21-month median OS for the amezalpat arm versus 15 months for the control arm, a six-month survival advantage.
- 20/40 patients remain in survival follow-up in the amezalpat arm, compared to 9/30 patients in the control arm.
- 0.65 hazard ratio for OS, revealing a stable HR since the top-line analysis 10 months earlier when the HR was 0.59.
- A manageable safety profile is consistent with Phase 1 data.
- amezalpat組的中位OS爲21個月，對照組爲15個月，優勢爲六個月。
- amezalpat組中有20/40名患者進行生存隨訪，對照組中有9/30名患者進行生存隨訪。
- OS的危險度比爲0.65，比頭條分析時10個月前的0.59相對穩定。
- 可管理的安全性與1期數據一致。
The earlier top-line data analysis, dated April 20, 2023, had a median follow-up of 9.2 and 9.9 months for the amezalpat and control arms, respectively and showed:
早期頭條數據分析於2023年4月20日，amezalpat組和對照組的中位隨訪時間分別爲9.2個月和9.9個月，並顯示：
- A confirmed objective response rate of 30% for the amezalpat arm versus 13.3% for the control arm.
- Biomarker subpopulation findings were consistent with the mechanism of action of amezalpat. Patients with b-catenin activating mutations (21% in this study (n=7)) showed a cORR of 43% and a disease control rate (DCR) of 100% in the amezalpat arm.
- The amezalpat arm was consistently active across both PD-L1 positive and PD-L1 negative tumors, with a cORR of 27% in the amezalpat arm compared to 7% for the control arm in PD-L1 negative tumors.
- amezalpat組的經確認的客觀反應率爲30％，對照組爲13.3％。
- 生物標誌物亞人群發現與amezalpat的作用機制一致。該研究中具有β-catenin激活突變（佔全部研究的21％（n = 7））的患者，在amezalpat組中的完全緩解率爲43％，疾病控制率爲100％。
- 無論PD-L1陽性還是PD-L1陰性腫瘤，amezalpat組都保持了一致的活性，在PD-L1陰性腫瘤中，amezalpat組的客觀緩解率爲27％，而對照組爲7％。
Amezalpat remains well tolerated, with safety data comparable between the two arms.
Amezalpat仍然耐受良好，兩組之間的安全數據相當。
HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030. Every year, more than 900,000 people worldwide are diagnosed with HCC.
HCC是一種具有不斷上升的死亡率的侵襲性腫瘤，並且預計將成爲2030年第三大癌症死亡原因。每年有超過900,000人被診斷患有HCC。
Price Action: TPST shares are down 16.5% at $2.38 before spiking as high as $4.82 during the premarket session at last check Thursday.
價格走勢：截至週四最後一次查詢，TPST股價下跌16.5％，報2.38美元，並在盤前交易中最高飆升至4.82美元。
Image by PDPics from Pixabay
來自Pixabay的PDPics圖片