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머크, ‘키트루다’ 단독요법 TNBC 적응증 추가 실패 - 바이오스펙테이터

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머크, ‘키트루다’ 단독요법 TNBC 적응증 추가 실패

입력 2019-05-23 06:40 수정 2019-05-23 11:11

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삼중음성유방암(TNBC) 대상 키트루다 단독요법 임상3상에서 1차 종결점 미충족..화학요법보다 전체생존기간(OS) 개선 실패

머크(Merck)는 PD-1 항체 '키트루다(Keytruda)'의 전이성 삼중음성유방암(mTNBC, metastatic Triple-negative Breast Cancer) 적응증 추가를 위한 임상3상(KEYNOTE-119, NCT02555657)에서 종결점을 충족하지 못했다고 지난 20일(현지 시간) 밝혔다.

에스트로겐 수용체(ER, Estrogen receptor), 프로게스테론 수용체(PR, Progesterone receptor), HER2(Human Epidermal growth factor Receptor 2)는 유방암 치료의 표적으로 사용한다. 대표적인 유방암 화학항암제 타목시펜(Tamoxifen)은 대사산물인 아피목시펜(Afimoxifene), 엔독시펜(Endoxifen)이 ER의 활성을 억제해 치료 효과를 보인다. HER2 항체 트라스투주맙(Trastuzumab)은 종양의 증식에 관여하는 HER2를 억제해 치료 효과를 낸다.

전체 유방암 환자의 약 10~20%를 차지하는 TNBC는 ER, PR, HER2를 발현하지 않기에, 기존 치료제로는 항암 효능이 떨어진다. TNBC 환자의 약 40%가 PD-L1 양성을 보이는 것이 알려지면서, PD-1/PD-L1 면역항암제를 이용해 TNBC 치료를 시도하고 있다.

머크는 2차, 3차 치료가 필요한 mTNBC 환자를 대상으로 키트루다 단독요법 효능을 파악하기 위한 KEYNOTE-119 연구를 진행했으며, 키트루다 투여 그룹을 화학항암제 투여 그룹과 비교했다. 화학항암제 투여 그룹은 임상시험에 참여한 의사의 선택에 따라 카페시타빈(Capecitabine), 에리불린(Eribulin), 젬시타빈(Gemcitabine), 비노렐빈(Vinorelbine) 중 한 가지를 처방받았다.

임상 결과, 키트루다는 화학항암제와 비교해 1차 종결점인 전체생존기간(OS, Overall Survival)을 개선하지 못한 것으로 나타났다. 키트루다의 새로운 부작용은 발견되지 않았으며, 머크는 자세한 결과를 의학 학회에서 발표할 예정이다.

로이 베인스(Roy Baynes) 머크 수석부사장은 “TNBC는 공격적인 암으로, 최초 표준치료 이후에 진행한 경우 치료하기 어렵다”며, “단독요법의 결과는 실망스럽지만, TNBC 치료를 위해 키트루다 연구를 계속할 것”이라고 밝혔다.

현재 머크는 키트루다의 TNBC 적응증 추가를 위해 화학항암제와 병용하는 3개의 임상3상(KEYNOTE-355, KEYNOTE-242, KEYNOTE-522)을 진행하고 있다.

한편, 로슈(Roche)의 자회사 제넨텍(Genentech)은 지난 3월 PD-L1 항체 티쎈트릭(Tecentriq), 화학항암제 아브락산(Abraxane) 병용요법을 미국 식품의약국(FDA)으로부터 신속승인(Accelerated approval)받았다. FDA의 신속승인으로 티쎈트릭은 면역항암제 중 첫번째 TNBC 치료제가 됐다.

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