Objective

Previously, Vigil demonstrated clinical benefit to prolong relapse free and overall survival in the BRCA wild-type (BRCA-wt), homologous recombination proficient (HRP) patient population. Here we provide long term follow up of 3 years in the HRP patient population enrolled in the Phase 2b VITAL study.

Methods

HRP patients treated with Vigil (n = 25) or placebo (n = 20) who were enrolled in the Phase 2b, double-blind, placebo-controlled (VITAL study, NCT02346747) were followed for safety, OS and RFS. OS and RFS from time of randomization (immediately prior to maintenance therapy) and from debulking tissue procurement time points were analyzed by Kaplan-Meier (KM) and restricted mean survival time (RMST) analysis.

Results

OS for Vigil treated patients at 3 years has not yet reached median OS time point (95% CI 41.6 months to not achieved) compared to 26.9 (95% CI 17.4 months to not achieved) in placebo treated patients (HR 0.417 p = 0.020). Three year RFS also showed benefit to Vigil (stratified HR 0.405, p = 0.011) and no long term toxicity to Vigil was observed. Three year OS for Vigil of 70% vs. 40% for placebo from time of randomization was observed (p = 0.019). RMST analysis was also significant for OS (45.7 vs. 32.8 months, p = 0.008) and RFS (p = 0.025).

Conclusion

In conclusion, results suggest durable activity of Vigil on RFS and OS and support further evaluation of Vigil in HRP ovarian cancer.

中文翻译：

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Gemogenovatucel-T (Vigil) 维持免疫治疗：同源重组熟练 (HRP) 卵巢癌的 3 年生存获益

客观的

此前，Vigil 在BRCA野生型 (BRCA-wt)、同源重组熟练 (HRP) 患者群体中证明了延长无复发和总生存期的临床益处。在这里，我们对参加 2b 期 VITAL 研究的 HRP 患者群体提供了 3 年的长期随访。

方法

 对参加 2b 期、双盲、安慰剂对照（VITAL 研究，NCT02346747）的接受 Vigil（n  = 25）或安慰剂（n = 20）治疗的 HRP 患者进行安全性、OS 和 RFS 跟踪。通过 Kaplan-Meier (KM) 和限制性平均存活时间 (RMST) 分析分析随机化时间（即在维持治疗之前）和减瘤组织采购时间点的 OS 和 RFS。

结果

Vigil 治疗患者的 3 年 OS 尚未达到中位 OS 时间点（95% CI 41.6 个月未达到），而安慰剂治疗患者的 OS 为 26.9（95% CI 17.4 个月未达到）（HR 0.417 p  = 0.020） . 三年 RFS 也显示出对 Vigil 的益处（分层 HR 0.405，p  = 0.011），并且没有观察到对 Vigil 的长期毒性。观察到从随机分组开始，Vigil 的三年 OS 为 70%，而安慰剂为 40% ( p  = 0.019)。RMST 分析对于 OS（45.7 与 32.8 个月，p  = 0.008）和 RFS（p  = 0.025）也很重要。

结论

总之，结果表明 Vigil 对 RFS 和 OS 的持久活性，并支持进一步评估 Vigil 在 HRP 卵巢癌中的作用。