Cancer-Focused ESSA Pharma Ends Prostate Cancer Trial Due to Insufficient Efficacy From Combination Therapy
Cancer-Focused ESSA Pharma Ends Prostate Cancer Trial Due to Insufficient Efficacy From Combination Therapy
A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study.On Thursday, ESSA Pharma Inc. (NASDAQ:EPIX) announced its plans to terminate the Phase 2 trial of masofaniten combined with enzalutamide versus enzalutamide single agent in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens.
週四，ESSA製藥公司（納斯達克股票代碼：EPIX）宣佈計劃終止馬索非尼特聯合恩扎魯他胺對比恩雜魯胺單一藥物的2期試驗，該試驗是針對轉移性去勢耐藥性前列腺癌（mcRPC）患者對第二代抗雄激素的轉移性去勢耐藥性前列腺癌（mcRPC）患者。
This decision was based on a protocol-specified interim review of the safety, PK, and efficacy data, which showed a much higher rate of PSA90 response in patients treated with Pfizer Inc's (NYSE:PFE) Xtandi (enzalutamide) monotherapy (which is the standard of care for this patient population) than expected based on historical data.
該決定基於協議中規定的對安全性、Pk和療效數據的中期審查，根據歷史數據，該審查顯示，接受輝瑞公司（紐約證券交易所代碼：PFE）Xtandi（恩扎魯胺）單一療法（該患者群體的護理標準）治療的患者的 PSA90 反應率遠高於預期。
In addition, there was no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent.
此外，與恩雜魯胺單劑相比，馬索非尼特加恩雜魯胺聯合使用沒有明顯的療效益處。
A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study.
一項徒勞性分析確定達到研究預先規定的主要終點的可能性很小。
The combination of masofaniten plus enzalutamide was well-tolerated with no new safety signals and a safety profile similar to that seen in Phase 1 studies.
masofaniten與恩雜魯胺的組合耐受性良好，沒有新的安全信號，其安全性與1期研究中的相似。
"We made the difficult decision to terminate this Phase 2 study following the interim analysis because we concluded that the emerging efficacy profile of masofaniten combined with enzalutamide would not likely meet the primary endpoint of the study, nor our internal requirements for a prostate cancer therapy candidate," said David Parkinson, President, and CEO.
總裁兼首席執行官戴維·帕金森表示：「在中期分析之後，我們做出了終止這項2期研究的艱難決定，因爲我們得出結論，masofaniten與恩雜魯胺聯合使用的新療效概況不太可能滿足該研究的主要終點，也不太可能滿足我們對前列腺癌候選療法的內部要求。」
As part of the effort to focus its resources, ESSA is also planning to terminate the other remaining company-sponsored and investigator-sponsored clinical studies evaluating masofaniten either as a monotherapy or in combination with other agents.
作爲集中資源的努力的一部分，ESSA還計劃終止其他由公司贊助和研究者贊助的評估masofaniten作爲單一療法或與其他藥物聯合使用的臨床研究。
As of September 30, 2024, the company had available cash reserves and short-term investments of $126.8 million and net working capital of $124.3 million.
截至2024年9月30日，該公司的可用現金儲備和短期投資爲1.268億美元，淨營運資金爲1.243億美元。
In September, ESSA Pharma announced the presentation of updated dose escalation data from its Phase 1/2 study of masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 European Society for Medical Oncology (ESMO) Congress.
9月，ESSA Pharma宣佈在2024年歐洲腫瘤內科學會（ESMO）大會上公佈了其馬索非尼特（前身爲 EPI-7386）與恩雜魯胺聯合使用的1/2期研究的最新劑量遞增數據。
Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 88% of patients (14 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA <0.2ng/mL.
在所有劑量組中，88％的患者（16人中有14人）在不到90天的時間內獲得了 PSA50，88％的患者（16人中有14人）獲得了 PSA90，69％的患者（16人中有11人）在不到90天的時間內獲得了 PSA90，63％的患者（16人中有10人）的PSA
Price Action: EPIX stock was down 69.80% at $1.57 during the premarket session at the last check on Friday.
價格走勢：在週五的最後一次盤前交易中，EPIX股價下跌69.80％，至1.57美元。
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譯文內容由第三人軟體翻譯。
