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한미-아테넥스 "오락솔·사이람자, 위암 1b상서 긍정적" - 바이오스펙테이터

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한미-아테넥스 "오락솔·사이람자, 위암 1b상서 긍정적"

입력 2018-12-13 11:23 수정 2018-12-13 11:23

바이오스펙테이터 장종원 기자

아테넥스 병용 1b상 중간결과 공개..250mg/㎡ 증량시 50% 부분반응

한미약품이 미국 아테넥스에 기술수출한 '오락솔'이 위암 치료제로서의 가능성을 보였다. 오락솔은 한미약품이 개발한 플랫폼기술 오라스커버리(ORASCOVERY)를 적용해 항암제 파클리탁셀 주사제를 경구용으로 전환한 신약후보물질이다.

아테넥스(Athenex)는 11일(현지시간)는 위암 환자를 대상으로 한 오락솔과 일라이 릴리의 항암제 사이람자(성분명 라무시루맙) 병용요법의 효능을 평가하는 1b상 중간 결과를 발표했다.

이번 중간 임상결과는 과거 항암화학요법에 실패한 위암 환자에게 오락솔을 200mg/㎡에서 250mg/㎡까지 증량해 효능과 안전성을 검증한 것이다.

오락솔 200mg/㎡을 투여받은 첫 번째 코호트의 경우 6명 중 2명(33.3%)이 부분반응(PR)을 보였고 1명(16.7%)은 종양이 더이상 자라지 않는 안정형병변(SD) 상태에 도달했다. 부작용은 참여자 1명에게서 4등급 호중구감소증이 보고됐으나 회복됐다.

오락솔을 250mg/㎡까지 증량한 두 번째 코호트에서는 6명 중 3명(50%)이 부분반응(PR)을 보였다. 이중 1명이 3등급 구토증상을 호소했으나 투약 중단후 회복됐다는게 회사측의 설명이다. 아테넥스는 현재 세 번째 코호트를 대상으로 오락솔을 300mg/㎡까지 증량하는 연구를 진행하고 있다.

이번 중간 결과 발표에 대해 Rudolf Kwan 아테넥스 CMO는 "오락솔의 강력한 항암효과가 재현됐다. 위암 환자의 2차치료제로써 오락솔과 라무시루맙의 우수한 효능과 안전성애 대한 긍정적인 결과가 기대된다"고 말했다.

현재 아테넥스는 전이성 유방암 환자 360명을 대상으로 오락솔(Oraxol) 임상 3상을 진행하고 있다. 아테넥스는 최근에는 전이성 유방암 및 지방육종 치료 주사제인 ‘Eribulin’(상품명 할라벤)’을 오라스커버리 기술을 통해 경구용으로 전환한 신약 후보물질 ‘Eribulin ORA’의 FDA 임상 승인도 받았다. 내년 1분기 1상 진입을 계획하고 있다.

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