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Why Is Repare Therapeutics Stock Trading Lower On Friday?

Why Is Repare Therapeutics Stock Trading Lower On Friday?

为什么Repare Therapeutics的股票在周五交易下跌?
Benzinga ·  12/13 11:09

On Thursday, Repare Therapeutics Inc (NASDAQ:RPTX) revealed data from its MYTHIC Phase 1 gynecologic expansion trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) for endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers.

周四,Repare Therapeutics Inc (纳斯达克:RPTX) 公开了其MYTHIC 1期妇科扩展试验的数据,该试验评估了lunresertib和camonsertib(Lunre+Camo)联合用于内膜癌和对铂金耐药的卵巢癌(PROC)患者的疗效,这些患者携带lunre敏感性生物标志物。

As of the data cut-off date of November 14, 51 evaluable patients were enrolled in the gynecologic cancer expansion cohort of the MYTHIC trial.

截至11月14日的数据截止日期,共有51名可评价患者参与了MYTHIC试验的妇科癌症扩展队列。

Across all tumor types treated at the optimized RP2D (n=67), Lunre+Camo therapy showed a favorable and differentiated tolerability profile compared to current and emerging therapies.

在优化RP2D(n=67)治疗的所有肿瘤类型中,Lunre+Camo治疗显示出与当前及新兴疗法相比,有良好且差异化的耐受性特征。

The most common adverse event was anemia (26.9%, Grade 3).

最常见的不良事件是贫血(26.9%,3级)。

Key Cohort Clinical Findings

关键队列临床发现

Key efficacy outcomes from 27 evaluable patients with endometrial cancer show:

来自27名可评价的内膜癌患者的关键疗效结果显示:

  • Overall response rate was 25.9% (confirmed ORR in 5 out of 7 patients).
  • Clinical benefit was observed in 48.1% of patients, with responses frequently occurring after 12 weeks or more.
  • At the 24-week landmark analysis, nearly half of patients experienced durable clinical benefit (24-week PFS [PFS24w] = 43%.
  • 总体反应率为25.9%(7名患者中确认的ORR为5名)。
  • 临床获益在48.1%的患者中观察到,反应通常发生在12周或更长时间之后。
  • 在24周的里程碑分析中,近一半的患者经历了持久的临床益处(24周无进展生存期[PFS24w] = 43%)。

Key efficacy outcomes in 24 evaluable Platinum-Resistant Ovarian Cancer patients show:

24例可评估的铂金耐药卵巢癌患者的关键疗效结果显示:

  • Overall response rate was 37.5% (confirmed ORR in 4 out of 9 patients).
  • Clinical benefit was observed in 79% of patients.
  • PFS at the 24-week landmark analysis was PFS24w = 45%.
  • 总体反应率为37.5%(在9名患者中确认的ORR为4名)。
  • 79%的患者观察到了临床益处。
  • 在24周的里程碑分析中,无进展生存期为PFS24w = 45%。

Repare has consulted with the FDA and the European Medicines Agency, who have guided the company's registrational development plans for Lunre+Camo in gynecologic tumors.

Repare已咨询FDA和欧洲药品管理局,他们指导公司Lunre+Camo在妇科肿瘤方面的注册开发计划。

Repare plans to provide the final Phase 3 trial protocols for regulatory clearance imminently and intends to start the first Phase 3 Lunre+Camo trial in endometrial cancer in the second half of 2025.

Repare计划尽快提供最终的第三阶段试验方案以获得监管批准,并打算在2025年下半年开始第一项针对子宫内膜癌的第三阶段Lunre+Camo试验。

Additionally, the company expects to initiate a small contribution of components trial in up to 40 patients with endometrial cancer in the first quarter of 2025.

此外,公司预计将在2025年第一季度启动一项对多达40名子宫内膜癌患者的小型元件试验。

Price Action: RPTX stock is down 52.4% at $1.89 at last check Friday.

价格走势:RPTX股票在上周五最后一次检查时下跌52.4%,股价为1.89美元。

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Photo via Shutterstock.

图片来自shutterstock。

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