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다케다, ‘닌라로’ 다발성골수종 1차 3상 '실패' - 바이오스펙테이터

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다케다, ‘닌라로’ 다발성골수종 1차 3상 '실패'

입력 2020-09-14 14:04 수정 2020-09-14 14:13

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‘새롭게 진단받은’ 다발성골수종 환자 대상..위약군 대비 닌라로 투약군에서 PFS 증가했지만 통계적 유의성 입증 실패

다케다(Takeda Pharmaceutical)가 다발성골수종 신규환자를 대상으로 한 ’닌라로(NINLARO, Ixazomib)' 3상에 실패했다. 닌라로 3제요법은 지난 2015년 치료경험이 있는 다발성골수종 환자를 대상으로 한 치료제로 미국 식품의약국(FDA)의 승인을 받았다. 이번에 신규 환자를 대상으로 한 1차 치료제로의 적응증 확대에 나섰으나 실패한 것이다.

다케다는 지난 9일 열린 SOHO(Society of Hematologic Oncology)에서 닌라로 3제 병용요법에 대한 TOURMALINE-MM2 임상 3상 결과를 발표했다. 임상결과, 닌라로는 무진행생존기간(Progression-Free Survival, PFS)의 1차 종결점(primary endpoint)을 충족하지 못했다.

이번 TOURMALINE-MM2 임상3상은 자가조혈모세포 이식이 불가능하고 새롭게 진단받은 다발성골수종 환자 701명을 대상으로 진행됐다(NCT01850524). 닌라로투약군 환자들은 레날리도마이드(lenalidomide)+덱사메타손(dexamethasone)+닌라로를 처방받았고, 위약군 환자들은 레날리도마이드+덱사메타손+위약(placebo)을 처방받았다.

그 결과 PFS 중간값은 닌라로투약군에서 35.3개월, 위약군에서 21.8개월이었다(Hazard Ratio[HR] 0.830; p=0.073). PFS 중간값은 위약군에 비해 닌라로투약군에서 13.5개월이 늘어났지만, 통계적 유의성을 인정받지 못해 1차 종결점에 도달하지 못했다.

주요 2차 종결점(secondary endpoint)인 완전관해(Complete Response, CR) 비율은 닌라로투약군에서 26%, 위약군에서 14%였다. 전체생존기간(Overall survival, OS)은 추적기간동안 두 그룹 모두 OS 중간값에 도달하지 못했다(HR 0.998). 종양진행기간(Time to Tumor Progression, TTP) 중간값은 닌라로투약군에서 45.8개월, 위약군에서 26.8개월이었다(HR 0.738).

닌라로는 프로테아좀(proteasome)저해제 기반의 경구용 항암제다. 골수종세포(myeloma cell)는 일반세포보다 프로테아좀에 의존적이기 때문에 프로테아좀의 저해로 골수종세포의 사멸을 유도할 수 있다고 알려져 있다.

티에리 파콘(Thierry Facon) TOURMALINE-MM2의 연구책임자는 “승인된 프로테아좀 저해제 기반 경구 치료제가 없기 때문에 닌라로에 대한 수요가 있다”며 “이번 임상결과가 앞으로의 다발성골수종 연구에 도움이 되길 바란다”고 말했다.

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