Transgene announces that its randomized Phase II study to evaluate TG 4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumors has not met the primary objective of the study (improvement in progression-free survival).

Transgene宣布，其评估TG 4001联合avelumab与单独avelumab治疗复发或转移性HPV16阳性宫颈和肛门生殖器肿瘤患者的随机II期研究尚未达到该研究的主要目标（改善无进展生存期）。

The pre-planned subgroup analysis showed a positive efficacy trend in favor of the TG 4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. These patients account for approximately half of the patients enrolled in the study.

预先计划的亚组分析显示，宫颈癌患者中含有TG 4001的方案有积极的疗效趋势，这需要通过其他分析（包括PD-L1状态）进一步证实。这些患者约占参与研究的患者的一半。

The treatment has been well tolerated. Adverse events are consistent with previous observations. .

治疗耐受性良好。不良事件与之前的观察结果一致。。

Transgene is currently evaluating the full study results in detail to determine the best way forward for this program and will communicate further once this is completed.

Transgene目前正在详细评估完整的研究结果，以确定该计划的最佳前进方向，并将在完成后进一步沟通。

TG 4001 was evaluated in a multi-center, open label, randomized Phase II trial (NCT03260023) designed to compare the efficacy of the combination of TG 4001 and avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital cancers who have disease progression after a maximum of one line of systemic treatment, or who are not eligible for first-line chemotherapy.

TG 4001在一项多中心，开放标签，随机II期试验（NCT03260023）中进行了评估，该试验旨在比较TG 4001和avelumab联合治疗与单独使用avelumab治疗复发或转移性HPV16阳性宫颈癌和肛门生殖器癌患者的疗效，这些患者在最多一行全身治疗后疾病进展，或者不符合一线化疗条件。

The overall trial enrolled 100 patients..

整个试验招募了100名患者。。

Condition: Cervical Cancer

病情：宫颈癌

Type: drug

类型：药物