Cancer-Focused EFFECTOR Therapeutics Shelves Development Of Lung Cancer Candidate After Disappointing Data
Cancer-Focused EFFECTOR Therapeutics Shelves Development Of Lung Cancer Candidate After Disappointing Data
Thursday, eFFECTOR Therapeutics Inc (NASDAQ:EFTR) released topline results from the primary analysis of the Phase 2 KICKSTART trial, which tested tomivosertib or placebo, each combined with Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab), as a frontline treatment for patients with non-small cell lung cancer with PD-L1 ≥50%.
週四，Effector Therapeutics Inc（納斯達克股票代碼：EFTR）公佈了2期KICKSTART試驗的初步分析結果，該試驗測試了tomivosertib或安慰劑，每種藥物均與默沙東公司（紐約證券交易所代碼：MRK）的Keytruda（pembrolizumab）聯合使用，作爲 PD-L1 ≥ 50% 的非小細胞肺癌患者的前線治療藥物。
Based on 36 events, the hazard ratio for progression-free survival (PFS, the study's primary endpoint) using a stratified Cox proportional hazards model was 0.62 in favor of tomivosertib.
基於36個事件，使用分層Cox比例風險模型的無進展存活率（PFS，該研究的主要終點）的危險比爲0.62，有利於tomivosertib。
The two-sided p-value for PFS, based on a stratified log-rank test, was 0.21, which did not meet the pre-specified threshold of p≤0.2.
根據分層對數等級檢驗，PFS 的雙面 p 值爲 0.21，未達到預先指定的閾值 p≤0.2。
The median PFS was 13.0 weeks in the tomivosertib plus pembrolizumab arm and 11.7 weeks in the placebo plus pembrolizumab arm, respectively. Overall survival results remain immature; however, no trend favoring tomivosertib was observed.
tomivosertib加pembrolizumab組的PFS中位數分別爲13.0周，安慰劑加pembrolizumab組的PFS中位數分別爲11.7周。總體存活結果仍不成熟；但是，沒有觀察到有利於tomivosertib的趨勢。
There were 67% Grade 3 or higher treatment-emergent adverse events in the tomivosertib plus pembrolizumab arm versus 37% in the placebo plus pembrolizumab arm.
tomivosertib加pembrolizumab組中出現了67％的3級或更高治療緊急不良事件，而安慰劑加pembrolizumab組的3級或更高治療不良事件爲37％。
"While there was evidence of modest tomivosertib activity in the trial, based on the totality of the data currently available, we do not see an obvious path forward to continue developing tomivosertib in frontline NSCLC," said Steve Worland, president and CEO of eFFECTOR.
Effector總裁兼首席執行官史蒂夫·沃蘭德表示：“儘管有證據表明試驗中tomivosertib的活性不大，但根據目前可用的全部數據，我們認爲在一線非小細胞肺癌中繼續開發tomivosertib沒有明顯的前進方向。”
The company said Zotatifin, with its novel mechanism distinct from tomivosertib, is a drug candidate poised to enter a randomized, potentially registrational trial in estrogen receptor-positive (ER+) breast cancer later this year.
該公司表示，佐他替芬的新機制與tomivosertib截然不同，是一種候選藥物，有望在今年晚些時候進入一項針對雌激素受體陽性（ER+）乳腺癌的隨機註冊試驗。
As a next step for the zotatifin program, the company expects to report additional data, including the recommended phase 2 dose (RP2D), for zotatifin combined with fulvestrant and abemaciclib in the second half of 2024.
作爲佐他替芬計劃的下一步，該公司預計將在2024年下半年報告更多數據，包括佐他替芬聯合富爾維司朗和阿貝馬西利布的推薦2期劑量（RP2D）。
In addition, as part of the strategy to leverage investigator-sponsored trials to conserve capital, the company said that a separate, investigator-sponsored trial of tomivosertib in acute myeloid leukemia (AML) will continue unchanged.
此外，作爲利用研究者贊助的試驗節省資金的戰略的一部分，該公司表示，另一項由研究者贊助的tomivosertib治療急性髓系白血病（AML）的試驗將繼續保持不變。
The mechanistic rationale to test tomivosertib in AML is entirely distinct from the rationale in NSCLC and relies on tomivosertib's potential to inhibit the production of survival proteins Mcl-1 and Bcl-2, which are required for leukemia cell survival.
在急性髓細胞白血病中測試tomivosertib的機理原理與非小細胞肺癌中的原理完全不同，它依賴於tomivosertib抑制白血病細胞存活所需的存活蛋白Mcl-1和Bcl-2生成的潛力。
The company anticipates that its cash, cash equivalents, and short-term investments of over $30 million will be sufficient to fund operations into the first quarter of 2025.
該公司預計，其超過3000萬美元的現金、現金等價物和短期投資將足以爲2025年第一季度的運營提供資金。
Price Action: EFTR shares are down 78.1% at $3.6 on the last check Thursday.
價格走勢：在週四的最後一次支票中，EFTR股價下跌78.1％，至3.6美元。