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머크-에자이, ‘키트루다+렌비마’ 간암 1상 “ORR 36%" - 바이오스펙테이터

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머크-에자이, ‘키트루다+렌비마’ 간암 1상 “ORR 36%"

입력 2020-06-02 07:09 수정 2020-06-02 19:56

바이오스펙테이터 서윤석 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
[ASCO 2020] 절제불가능한 간암환자 대상 전체반응률(ORR) 36%, 반응지속기간(DOR) 12.6개월 "항암효과, 안정성 확인"

미국 머크(MSD)와 에자이(Eisai)는 간암을 대상으로 진행한 '키트루다(Keytruda, pembrolizumab)+렌비마(Lenvima, lenvatinib)' 임상 1상에서 전체반응률(ORR) 36%의 결과를 내놨다. 간암의 1차 치료제로 사용되는 '넥사바(Nexavar, sorafenib)'와 '렌비마'의 ORR은 각각 7%, 19%에 불과하다.

현재 절제불가능한 간암에 대한 1차 치료제로는 바이엘의 ‘넥사바’, 에자이의 ‘렌비마’가 사용되고 있다. 렌비마는 넥사바와 비교평가한 임상 3상에서 간암의 주요 평가지표인 전체생존률(OS)은 차이가 없었지만 무진행생존기간(progression-free survival, PFS)을 증가시킨 결과로 2018년 미국 식품의약국(FDA)에서 판매를 승인받았다.

미국 머크(MSD)와 에자이(Sisai)는 지난달 28일(현지시간) 치료받은적 없는 절제불가능한 간암(unresectable hepatocellular carcinoma, uHCC)을 대상으로 진행한 PD-1 항체 ‘키트루다’와 다중수용체 티로신 키나제 억제제 ‘렌비마’ 병용요법 임상 1상(Keynote-524/Study 116, NCT03006926)에서 의미있는 전체반응률(ORR)을 나타낸 결과를 미국 임상 종양학회(ASCO)에서 발표했다(Abstract # 4519).

머크는 기존에 치료받은적 없는 절제불가능한 간암환자 100명을 대상으로 렌비마를 1일1회, 키트루다를 3주에 1회 투여했다. 머크는 전체반응률(overall response rate, ORR)과 반응지속기간(duration of response, DOR)을 1차 종결점으로 설정해 ‘키트루다+렌비마’의 효과를 평가했다....

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