메드팩토 항암신약 백토서팁, 면역항암제와 병용임상 2상 승인

(서울=연합뉴스) 계승현 기자 = 메드팩토[235980]는 항암신약 '백토서팁'(Vactosertib, TEW-7197)과 다국적제약사 MSD의 면역항암제 '키트루다'(성분명 펨브롤리주맙)를 비(非)소세포폐암 1차 치료 환자에 병용 투여하는 임상 2상 계획을 식품의약품안전처로부터 승인받았다고 7일 밝혔다.

메드팩토 로고

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이번 임상은 약 2년간 삼성서울병원 등 5개 의료기관에서 환자 55명을 대상으로 약물 병용투여의 유효성과 안전성을 평가하는 방식으로 이뤄진다. 병용 투여란 항암제의 치료 효과를 높이기 위해 2가지 이상의 약물을 함께 사용하는 것을 말한다.

메드팩토 관계자는 "이번 임상은 1차 치료 시험으로, 기존에 치료를 받은 적 없는 환자를 대상으로 하기 때문에 안정적인 데이터와 높은 객관적 반응률(ORR)이 기대된다"고 말했다.

1차 치료제란 환자가 병을 진단받은 후 가장 처음으로 사용하는 의약품을 말한다. 1차 치료 임상 환자들의 경우 약에 대한 내성과 부작용 경험이 없기 때문에 높은 치료 효과가 기대된다고 회사 측은 설명했다.

현재 1차 치료제로 쓰이는 키트루다는 단독 사용 시 암세포 표면 단백질인 'PD-L1' 발현율 50% 이상인 환자군에서 치료 효과를 보인다. 그러나 발현율 50% 미만인 환자군에서는 기존 화학요법 효과를 뛰어넘지 못하고 있다.

반면 키트루다와 백토서팁 병용 임상은 PD-L1 발현율 1% 이상의 환자를 대상으로 하고 있어, 반응률이 낮았던 환자군에 새로운 치료 옵션이 될 것으로 회사 측은 기대하고 있다.

key@yna.co.kr

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