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에이치엘비 "리보세라닙 1차지표 OS 목표치 미달" - 바이오스펙테이터

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에이치엘비 "리보세라닙 1차지표 OS 목표치 미달"

입력 2019-06-27 14:27 수정 2019-06-27 14:52

바이오스펙테이터 장종원 기자

통계적 유의성 분석결과 최종 목표치에 도달 못해.."FDA 허가 신청 쉽지 않을 것으로 판단"

에이치엘비 자회사 LSKBiopharma(LSKB)가 진행한 위암 글로벌 3상 시험 결과가 1차 유효성 평가지표인 전체생존기간(OS)의 목표치에 도달하지 못했다.

진양곤 에이치엘비 회장은 27일 기업설명회를 열어 "리보세라닙은 플라시보 대조군 대비 더 좋은 OS 중간값을 보였고, 이는 기존에 허가받은 약물대비 유사한 수준"이라면서 "하지만 통계적 유의성 분석 결과 1차 유효성 평가지표인 OS가 최종 목표치에 도달하지 못한 것으로 판단한다"고 말했다.

이어 "이번 임상 결과치로는 미국 식품의약국(FDA) 허가 신청이 쉽지 않을 것이라는 것이 내부적인 판단"이라고 덧붙였다.

다만 무진행 생존기간(PFS, Progression free survival)의 중간값은 대단히 유의미한 수준으로 나타났고 부작용도 경미한 수준으로 기존 연구사례와 크게 다르지 않았다고 진 회장은 설명했다.

진 회장은 "임상 결과치가 최종 확정되는대로 FDA와 방향성 논의하고 확정하는 작업을 진행할 것"이라면서 "LSKB는 ORR, DCR 등 추가 데이터와 생존환자를 분석해 9월말 유럽종양학회(ESMO)에서 공식 발표할 것"이라고 설명했다.

진 회장은 다만 "현재 판단으로는 리보세라닙의 다양한 적응증 확장, 콤보임상은 전혀 영향을 받지 않을 것으로 생각한다"면서 "현재 데이터를 볼때 리보세라닙의 2차 치료제 가능성도 높아졌다고 판단한다. 데이터를 기초로 다양한 파이프라인을 확장하는 전략적인 판단을 할 것이며 확정되는 대로 발표할 것"이라고 덧붙였다.

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