세계적 의학저널 란셋, 에페글레나타이드 심혈관계 안전성 주목-NSP통신

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세계적 의학저널 란셋, ‘에페글레나타이드’ 심혈관계 안전성 주목

NSP통신, 이준석 기자, 2021-10-18 13:31 KRD7 R0

#한미약품 #란셋 #에페글레나타이드 #심혈관계

(서울=NSP통신) 이준석 기자 = 한미약품이 개발해 미국 제약바이오 기업 스펙트럼에 라이선스 아웃한 폐암 혁신신약 ‘포지오티닙’의 연구자 임상 결과가 ‘글로벌 논문 피인용 지수’(Impact Factor) 44.54인 세계적 권위의 국제 학술지에 실렸다.

미국임상종양학회(ASCO)가 발간하는 SCIE급 국제학술지인 Journal of Clinical Oncology(이하 JCO)는 지난 9월 22일 임상 연구자이며 교신저자인 미국 텍사스 MD 앤더슨 암센터의 존 헤이맥(John V. Heymach)교수 그룹 주도로 진행한 포지오티닙의 임상 2상 내용을 등재했다.

이 연구는 포지오티닙 16mg 1일 1회 용법(QD)으로 28일 주기 치료를 받은 HER2 변이 비소세포폐암 환자 30명을 분석했다. 환자 연령 중앙값은 60세였으며, 90%가 백금항암화학요법, 80%가 PD-(L)1 억제제를 투여받았다.

G03-8236672469

연구에 따르면 포지오티닙은 HER2 Exon 20 변이에서 긍정적 항종양 활성화를 보였으며, 무진행생존기간 중간값(mPFS)은 5.5개월, 반응지속기간의 중간값(mDOR)은 5개월이었다. 포지오티닙의 안전성은 기존에 허가받은 2세대 pan-HER2 억제제와 유사한 수준으로, 피부발진, 설사, 손발톱주위염증 등 부작용은 전반적으로 관리 가능한 수준이었다.

한미약품 관계자는 ＂의학적 수요가 매우 높지만 현재까지 사용할 수 있는 치료제가 제한돼 있는 분야에서 포지오티닙의 혁신적 잠재력을 인정받아 권위있는 국제 학술지에 등재된 것 ＂이라고 평가했다.

포지오티닙은 올해 3월 미국 FDA로부터 패스트트랙 개발 약물로 지정됐으며, 한미약품 파트너사인 스펙트럼은 올해 말 FDA에 시판허가 신청서를 제출할 계획이다.

스펙트럼 조 터전 사장은 ＂포지오티닙의 긍정적 코호트2 데이터를 기반으로 시판허가 신청을 적극적으로 준비하고 있으며, 이는 스펙트럼의 중요한 이정표가 될 것 ＂이라 말했다.

한미약품 권세창 사장은 ＂파트너사와 긴밀한 협업을 통해 올해중 FDA 시판허가를 신청하고, 내년에 승인받아 상용화 하는 계획에 차질이 없도록 최선을 다하겠다 ＂고 말했다.