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AZ, '린파자 병용' 재발성 난소암 3상 "실패" - 바이오스펙테이터

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AZ, '린파자 병용' 재발성 난소암 3상 "실패"

입력 2020-03-16 07:09 수정 2020-03-16 07:09

바이오스펙테이터 봉나은 기자

‘린파자+리센틴’ 병용요법이 표준치료법인 백금기반 화학항암요법 대비 무진행 생존기간(PFS) 개선 못해 1차 종결점 충족 실패

아스트라제네카가 재발성 난소암 환자를 대상으로 ‘린파자’ 병용요법과 표준치료법을 비교한 임상3상에서 1차 종결점 충족에 실패했다.

아스트라제네카와 미국 머크(MSD)는 12일(현지시간) 백금 민감성(platinum-sensitive) 난소암 재발 환자 대상의 GY004 임상3상(NCT02446600)에서 린파자(Lynparza, 성분명: olaparib)와 리센틴(Recentin, 성분명: cediranib)을 병용한 치료요법이 표준치료법인 백금기반 화학항암요법 대비 무진행 생존기간(PFS) 지표를 개선하지 못해 1차 종결점 달성에 실패했다고 발표했다.

린파자는 아스트라제네카가 2017년 미국 머크와 공동개발 및 공동상용화에 대한 전략 계약을 맺어 개발한 약물로, 전세계에서 승인을 받은 첫 PARP(poly ADP ribose polymerase) 저해제다. 현재 전세계 73개국에서 백금 민감성 난소암 재발 환자의 유지치료제(maintenance therapy)로 판매되고 있다.

리센틴은 종양의 신생혈관 형성을 막아 종양 성장을 억제하도록 작용하는 경구용 VEGFR(vascular endothelial growth factor receptor) 저해제 후보물질이다. 아스트라제네카는 지난 2월 난소암 환자의 2차 치료제로 리센틴+화학항암제 병용요법에 대한 판매허가를 올해 하반기 또는 내년 중 신청할 계획이라고 밝혔다.

이번 GY004 임상은 BRCA 변이 유무에 따른 재발성 백금 민감성 난소암, 나팔관암(fallopian tube cancer), 원발성 복막암(primary peritoneal cancer) 환자 549명을 대상으로 진행된 가운데, 미국 국립보건원(NIH) 산하 국립암연구소(NCI)가 지원하고 NRG 온콜로지(NRG Oncology)가 이끌었다. 이 과정에서 아스트라제네카는 국립암연구소(NCI)와의 공동연구 개발 계약을 통해 GY004 임상에 린파자와 리센틴을 제공했다.

그 결과, 국립암연구소와 NRG 온콜로지는 임상에 참여한 전체 환자군(intent-to-treat, ITT)에서 린파자+리센틴 병용요법이 백금기반 화학항암요법 대비 통계적으로 유의미하게 PFS를 개선시키지 못해 1차 종결점을 충족하지 못한 결과를 확인했다.

국립암연구소와 NRG 온콜로지는 자세한 임상결과를 향후 관련 학회에서 발표할 예정이다.

José Baselga 아스트라제네카 종양학 R&D 부문 부사장은 “이번 결과가 실망스럽지만, 진행성 난소암 환자에게 린파자의 임상적 이점을 제공하기 위한 노력은 계속해서 이어갈 것”이라며, “향후 NRG 온콜로지와 긴밀히 협력해 진행중인 연구에 대한 전체 결과를 검토해 발표할 예정”이라고 말했다.

한편, 아스트라제네카는 진행성 난소암 환자에게 린파자+리센틴 병용요법을 적용하는 임상으로 CONCERTO 임상2상, GY005 임상2/3상(미국 NCI 지원), ICON9 임상3상(영국 UCL 지원)도 진행하고 있다.

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