Opdivo Approves Additional First-Line Treatment For Progressive, Metastatic Esophageal Cancer Without Ablation
상태바
Opdivo Approves Additional First-Line Treatment For Progressive, Metastatic Esophageal Cancer Without Ablation
  • 이경희 기자
  • 승인 2023.03.27 17:35
  • 댓글 0
이 기사를 공유합니다

Combination of Yervoy and chemotherapy...Improve overall survival and demonstrate safety

Opdivo(Nivolumab), an anti-PD-1 monoclonal antibody, was recently approved by the Ministry of Food and Drug Safety for PD-L1 expression positive(≥1%) and additional indications for two combination therapies such as △opdivo-Yervoy(ifilimub) △opdivo-chemotherapy in the first treatment of incurable progressive or metastatic esophage squamous cell carcinoma (ESCC).

The approval was based on multicenter, global, randomized, and open-label phase 3 clinical CheckMate-648 (ONO-4538-50/CA209648), which compared and evaluated the combination of opdivo-yervoy and opdivo-chemotherapy alone in patients with irreducible progressive, recurrent or metastatic esophageal squamous cell cancer.

Phase 3 clinical results showed statistically significant and clinically significant overall survival (OS) improvements in two combination therapies using Opdivo in the pre-specified interim analysis, and in all randomly assigned patients with PD-L1 expression rate of 1% or more compared to chemotherapy alone, and safety profiles.


댓글삭제
삭제한 댓글은 다시 복구할 수 없습니다.
그래도 삭제하시겠습니까?
댓글 0
댓글쓰기
계정을 선택하시면 로그인·계정인증을 통해
댓글을 남기실 수 있습니다.
주요기사
이슈포토