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.
essa pharma公司（納斯達克：EPIX）週四宣佈計劃終止合併依諾肟與依諾肟單藥治療轉移性去勢抵抗性前列腺癌（mCRPC）未接受第二代抗雄激素患者的2期臨床試驗。
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.
該決定是基於對安進（enzalutamide）單藥治療（這是該患者群體的標準護理）的PSA90反應率比歷史數據預期更高的安進（enzalutamide）單藥治療的患者的安全性、藥代動力學和療效數據進行的方案規定的中期審查。
In addition, there was no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent.
此外，與依諾肟單藥相比，依諾肟與依諾肟聯合應用的療效優勢並不明顯。
A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study.
療效性分析確定了實現研究預定義主要終點的可能性較低。
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.
依諾肟與依諾肟聯合應用在安全性上耐受良好，沒有出現新的安全信號，並且安全性概要與1期研究中看到的類似。
"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.
「我們根據中期分析做出了終止這個2期研究的艱難決定，因爲我們認爲依諾肟與依諾肟聯合應用的新療效概貌可能不會達到研究的主要終點，也不符合我們對前列腺癌治療候選藥的內部要求，」 David Parkinson，總裁兼首席執行官如是說。
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.
作爲專注資源的一部分，ESSA還計劃終止其他剩餘的公司贊助和調查員贊助的臨床研究，評估馬索法替單獨或與其他藥物聯合使用的情況。
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，該公司可用現金儲備和短期投資分別爲12680萬元人民幣，淨營運資本爲12430萬元人民幣。
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.
ESSA Pharma在2024年歐洲醫學腫瘤學會（ESMO）大會上宣佈更新劑量遞增數據，這是masofaniten（前身爲EPI-7386）與enzalutamide聯合治療1/2期研究的成果。
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中的14）達到了PSA50，88%的患者（16中的14）達到了PSA90，69%的患者（16中的11）在不到90天的時間內達到了PSA90，63%的患者（16中的10）達到了PSA
Price Action: EPIX stock was down 69.80% at $1.57 during the premarket session at the last check on Friday.
股價表現: EPIX股票在上週五預市交易時下跌69.80%，報1.57美元。
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