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머크, ‘키트루다 단독’ 대장암 3상 중간결과 ”PFS 개선” - 바이오스펙테이터

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머크, ‘키트루다 단독’ 대장암 3상 중간결과 ”PFS 개선”

입력 2020-04-06 08:14 수정 2020-04-06 13:53

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이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
1차 표준치료제와 비교 임상서 1차 종결점 중 하나인 PFS 유의미하게 개선..DMC, OS 확인 위한 '임상진행' 권고

미국 머크(MSD)의 PD-1 면역항암제 ‘키트루다(Keytruda)’가 MSI-H/dMMR 바이오마커를 가진 전이성 대장암(Colorectal Cancer, mCRC)에 대한 1차 표준치료제와의 직접비교(head-to-head) 임상에서 대조군 대비 무진행 생존기간(PFS)이 개선된 결과를 내놨다.

머크는 키트루다가 이번 임상을 통해 MSI-H/dMMR 대장암에 대한 '첫 단일요법' 치료제로 가능성을 보인 것이라 설명했다.

머크(MSD)는 2일(현지시간) 진행성 MSI-H(microsatellite instability-high)/dMMR(mismatch repair deficient) 전이성 대장암 환자를 대상으로 1차 표준치료제로 사용되는 화학요법과 ‘키트루다(Keytruda, pembrolizumab)’의 효과를 비교한 Keynote-177 임상 3상(NCT02563002)의 긍정적인 중간결과를 발표했다.

머크는 지난 2017년 미 식품의약국(FDA)으로부터 MSI-H/dMMR을 바이오 마커로 가지고 있는 모든 고형암 환자를 대상으로 한 치료제로 키트루다를 승인받았다. 키트루다는 MSI-H/dMMR 바이오 마커를 가진 고형암 환자 149명에서 전체반응률(overall response rate, ORR) 39.6%, 반응을 보인 환자의 78%는 6개월 이상의 약물 반응기간(durability of response, DOR)을 나타냈다....

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