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%.
周四，Effector Therapeutics Inc（纳斯达克股票代码：EFTR）公布了2期KICKSTART试验的初步分析结果，该试验测试了tomivosertib或安慰剂，每种药物均与默沙东公司（纽约证券交易所代码：MRK）的Keytruda（pembrolizumab）联合使用，作为 PD-L1 ≥ 50% 的非小细胞肺癌患者的前线治疗药物。
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.
基于36个事件，使用分层Cox比例风险模型的无进展存活率（PFS，该研究的主要终点）的危险比为0.62，有利于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.
根据分层对数等级检验，PFS 的双面 p 值为 0.21，未达到预先指定的阈值 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组的PFS中位数分别为13.0周，安慰剂加pembrolizumab组的PFS中位数分别为11.7周。总体存活结果仍不成熟；但是，没有观察到有利于tomivosertib的趋势。
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组中出现了67％的3级或更高治疗紧急不良事件，而安慰剂加pembrolizumab组的3级或更高治疗不良事件为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总裁兼首席执行官史蒂夫·沃兰德表示：“尽管有证据表明试验中tomivosertib的活性不大，但根据目前可用的全部数据，我们认为在一线非小细胞肺癌中继续开发tomivosertib没有明显的前进方向。”
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.
该公司表示，佐他替芬的新机制与tomivosertib截然不同，是一种候选药物，有望在今年晚些时候进入一项针对雌激素受体阳性（ER+）乳腺癌的随机注册试验。
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.
作为佐他替芬计划的下一步，该公司预计将在2024年下半年报告更多数据，包括佐他替芬联合富尔维司朗和阿贝马西利布的推荐2期剂量（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，作为利用研究者赞助的试验节省资金的战略的一部分，该公司表示，另一项由研究者赞助的tomivosertib治疗急性髓系白血病（AML）的试验将继续保持不变。
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.
在急性髓细胞白血病中测试tomivosertib的机理原理与非小细胞肺癌中的原理完全不同，它依赖于tomivosertib抑制白血病细胞存活所需的存活蛋白Mcl-1和Bcl-2生成的潜力。
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.
该公司预计，其超过3000万美元的现金、现金等价物和短期投资将足以为2025年第一季度的运营提供资金。
Price Action: EFTR shares are down 78.1% at $3.6 on the last check Thursday.
价格走势：在周四的最后一次支票中，EFTR股价下跌78.1％，至3.6美元。
译文内容由第三方软件翻译。