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제넨텍, 혈액암 ADC '폴리비' 병용요법 FDA 가속승인 - 바이오스펙테이터

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제넨텍, 혈액암 ADC '폴리비' 병용요법 FDA 가속승인

입력 2019-06-12 15:53 수정 2019-06-12 15:53

바이오스펙테이터 봉나은 기자

미만성 거대 B 세포 림프종(DLBCL) 대상 ‘폴리비+BR(벤다무스틴, 리툭산)’ 병용요법..GO29365 1b/2상서 완전반응(CR) 보인 환자 45%..기존 B세포 NHL 환자 ‘리툭산+화학항암제(BR)’ 병용요법 치료군(18%)보다 높은 수치

제넨텍(Genentech)의 항체-약물 접합체(Antibody-drug conjugate, ADC) 폴리비(Polivy, 성분명: polatuzumab vedotin-piiq)의 병용요법이 혈액암 치료제로 미국 식품의약국(FDA)으로부터 가속승인(Accelerated approval)을 받았다. 제넨텍은 지난해 11월말 새로 진단받은 급성 골수성 백혈병(AML) 환자를 대상으로 승인받은 벤클렉스타(Venclexta)와 저메틸화 작용제 병용요법에 이어, FDA의 승인을 받은 총 5개의 혈액암 치료제 파이프라인을 갖게 됐다.

FDA는 지난 10일 재발성/불응성 미만성 거대 B 세포 림프종(DLBCL) 성인 환자의 치료제로 폴리비와 벤다무스틴(bendamustine), 리툭산(Rituxan, 성분명: rituximab)을 병용하는 치료요법을 가속승인했다. FDA는 이번 승인에 대해 미만성 거대 B 세포 림프종 환자를 위한 첫 화학면역요법(chemoimmunotherapy)이라고도 밝혔다.

폴리비는 시애틀 제네틱스(Seattle Genetics)의 ADC 기술을 이용해 ‘항 CD79b 항체’와 튜불린 중합반응 저해제 ‘MMAE(Monomethyl auristatin E)’를 연결시킨 약물이다. CD79b는 B 세포 비호지킨 림프종(NHL)에서 특이적으로 높게 발현되는 단백질로 알려졌다. 이러한 CD79b에 결합하는 폴리비는 B 세포 사멸에 있어 종양 세포에서의 효과를 최대화하는 동안 정상 세포에 미치는 효과는 최소화시킬 수 있도록 고안됐다. 폴리비는 벤다무스틴, 리툭시맙과 1일 1회씩 90분간 투여되며, 21일씩 6사이클에 걸쳐 처방될 예정이다. 환자 1명이 4개월간 치료받을 경우 폴리비 치료비만 약 9만달러(약 1억620만원)가 들게된다.

FDA는 임상 기간동안 관찰된 완전반응률(CRR) 결과에 기반해 '가속승인'이라는 결정을 내렸다. 제넨텍은 최소 2개 이상의 치료 요법에 실패한 비호지킨 림프종 환자 중 가장 흔한 미만성 거대 B 세포 림프종 환자를 대상으로 GO29365 임상 1b/2상(NCT02257567)을 진행했다. 그 결과, 폴리비와 BR(벤다무스틴, 리툭산)을 처방받은 환자의 40%가 평가 기간동안 암이 관찰되지 않은 완전반응(CR)을 보였다. 반면, BR을 단독으로 투여받은 환자 중 완전반응을 보인 환자는 18%였다. 치료 후 객관적 반응을 보인 환자는 폴리비+BR 투여군에서 45%, BR 단독 투여군에서 18%였다. 또한 완전반응이나 부분반응을 보인 환자 중 반응지속기간(DOR)이 최소 6개월 이상인 환자는 폴리비+BR 투여군에서 64%, BR 단독 투여군에서 30%였으며, 반응지속기간이 최소 1년 이상인 환자는 폴리비+BR 투여군에서 48%, BR 단독 투여군에서 20%로 관찰됐다.

이상반응은 20% 이상의 환자에게서 관찰됐다. 폴리비+BR 투여군 및 BR 단독 투여군 중 5% 이상의 환자는 낮은 백혈구 세포 수, 혈소판 수치, 적혈구 세포 수, 무감각, 저림, 손발 통증, 설사, 열, 식욕부진, 폐렴 등을 보였다.

산드라 호닝(Sandra Horning) 제넨텍 의학총괄책임자(CMO) 겸 글로벌 제품개발 부문 대표는 “다양한 치료법에도 불응성이거나 재발성을 보이는 환자에게 주어지는 치료 옵션은 매우 제한적”이라며, “폴리비 병용요법이 특정 환자군을 위한 중요한 치료법"임을 강조했다.

한편, 제넨텍은 GO29365 임상 1b/2상에서 미만성 거대 B 세포 림프종 외 재발성/불응성 여포성 림프종(FL) 환자에게 폴리비를 적용한 결과도 관찰 중이다.

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