Phase III Clinical Trial of Trastuzumab Deruxtecan as First-Line Therapy for HER2-Expressing, pMMR Advanced or Recurrent Endometrial Cancer Initiated in China

On November 5, the CDE website showed that AstraZeneca registered a Trastuzumab Deruxtecan project.（DS8201a）FrontlineTreatment of HER2-expressing, mismatch repair-proficient (pMMR) primary advanced or recurrentEndometrial CancerPhase III study.

Screenshot source: CDE official website

This is an international multicenter study, with the target number of participants in China.81 people, International Target Enrollment480 people。

The primary objective of this study is to evaluate progression-free survival assessed by BICR.（PFS）, proving Trastuzumab Deruxtecan（T-DXd）First-line monotherapy compared with SoC for HER2-expressing (IHC 3+/IHC 2+), pMMR, primary advanced(Stage III/IV)Or the effectiveness in subjects with recurrent EC.

Trastuzumab deruxtecan is a key ADC drug from Daiichi Sankyo and AstraZeneca. Since its initial approval in 2019, the drug has been approved for marketing in multiple countries and regions, including the United States, Japan, the European Union, and China. Its indications cover HER2-positive breast cancer, HER2-low breast cancer, HER2-positive gastric cancer, HER2-mutant non-small cell lung cancer, and HER2-positive solid tumors.

This study is Trastuzumab DeruxtecanFirst Launch for Endometrial CancerPhase III Study.

Efficacy and Safety Study DESTINY-PanTumor02 of T-DXd in HER2-Expressing Solid Tumors Presented at 2023 ASCO (DP-02) Mid-term results.

DP-02 Study in HER2-expressing (IHC 3+/IHC 2+) patients with locally advanced or metastatic solid tumors who have progressed after ≥1 prior lines of systemic therapy (Tx) or have no available treatment options.

The results showed that, in all 267 patients, the ORR was 37.1%, and the median DOR(mDOR) For 11.8 months;In patients with IHC 3+ expression, the ORR was 61.3%, and the mDOR was 22.1 months.。

Among them, in 40 patients with endometrial cancer,ORR was 57.5%; Among 13 endometrial cancer patients with IHC 3+ expression,ORR reached 84.6%, the data performance is excellent.

Screenshot source: Insight database

T-DXd demonstrated encouraging ORR, particularly in patients with IHC 3+ expression, showing durable clinical benefits and manageable safety. These interim results suggest that T-DXd is a potential new therapeutic option for patients with HER2-expressing solid tumors.

Source: Corporate Logo

Disclaimer:This article is for information sharing only, and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If necessary, please consult and contact正规医疗机构.

Editor：vvy

PR Article Coordination: WeChat insightxb

SubmissionWeChat: insightxb; Email: insight@dxy.cn

Diversified functions, traceable data……

Insight Database Web Version Awaits Your Experience

Click to read the original text,ImmediatelyUnlock！