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348 Warning: mysql_real_escape_string(): Access denied for user 'et1ssh96'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_query(): Access denied for user 'et1ssh96'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 531 스펙트럼 발표, 한미 '포지오티닙' 임상결과 "ORR 55%" - 바이오스펙테이터

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스펙트럼 발표, 한미 '포지오티닙' 임상결과 "ORR 55%"

입력 2018-09-27 06:34 수정 2018-09-27 12:13

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세계폐암학회(WCLC)서 발표.."EGFR exon20 코호트 ORR 55%, PFS 5.5개월, HER2 exon20 코호트 ORR 50%, PFS 5.1개월"

한미약품 포지오티닙이 비소세포폐암 임상2상에서 55%의 높은 반응률을 보인다는 중간분석 결과가 나왔다. 기존 TKI, PD-1/PD-L1 약물의 3~19% 반응률과 비교하면 고무적인 결과다. 포지오티닙은 한미약품이 2015년 미국 스펙트럼 파마슈티컬에 기술수출한 pan-HER 저해제다.

스펙트럼은 24일(현지시간) 캐나다 토론토에서 열린 ‘제19회 세계폐암학회(WCLC)’에서 이전에 치료 경험이 있는 전이성 EGFR 및 HER2 엑손(Exon) 20 변이 비소세포폐암 환자 대상 임상연구(NCT03066206)의 중간결과를 발표했다.

임상시험을 담당한 MD앤더슨 암센터의 존 헤이맥(John Heymach) 교수는 구두발표에서 “EGFR 코호트에서 객관적반응률(ORR) 55%, HER2 코호트는 ORR 50%에 달했다”며 “현재 Exon 20 변이에 대한 마땅한 치료법은 없다. 이런 상황에서 치료경험이 있는 환자에서 포지오티닙이 임상적 효능과 함께 통제 가능한 안전성 프로파일을 보인 것은 매우 고무적이다”고 말했다.

발표에 따르면 EGFR, HER2 exon20 변이는 다양한 암 유형에서 나타난다. 특히 EGFR 및 HER2 exon20 변이는 미국과 중국에서 매년 3.6%(7700명), 6.3%(41100명)의 환자가 발생한다.

그러나 기존 치료약물의 반응률은 저조하다. 헤이맥 교수는 “1, 2세대 티로신 카이네이즈 억제제(TKI) 약물의 반응률은 3% 또는 8%에 불과하다. HER2 exon20 변이 TKI 반응률은 11.9%로 약간 높은 편이다. EGFR exon20 삽입(763insFQEA) 환자의 PFS 중간값은 2개월에 불과하다”며 “현재까지 가장 고무적인 결과는 로슈의 캐싸일라(T-DM1) 투여로 환자 11명 중 6명에서 반응을 보였다는 데이터다. 비표적 치료법의 경우 도세탁셀은 9~13%, PD-1/PD-L1 요법은 3.6~19% 반응률을 보인다”고 설명했다....

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