先聲藥業(02096.HK)合作伙伴宣佈獲美國FDA批准短效CDK4/6抑制劑Cosela(trilaciclib)
格隆匯2月15日丨先聲藥業(02096.HK)公佈，公司合作伙伴G1 Therapeutics,Inc.(納斯達克股票代碼：GTHX)，一家腫瘤治療公司，宣佈美國食品藥品監督管理局("FDA")已批准注射用COSELA™(trilaciclib)，以降低擴散期小細胞肺癌成人患者因鉑類╱依託泊苷方案或拓撲替康方案化學治療導致的骨髓抑制的發生率。COSELA是旨在化療期間主動幫助保護骨髓細胞(骨髓保護)的首創及唯一療法。
COSELA™(trilaciclib)是一種CDK4/6激酶抑制劑，可幫助降低擴散期小細胞肺癌成人患者因鉑類╱依託泊苷方案或拓撲替康方案化療導致的骨髓抑制的發生率。與化療相反，COSELA™(trilaciclib)通過獨特的作用機制為骨髓抑制提供首創療法，該作用機制事先可保護骨髓免受化療損害。於臨牀試驗中，在小細胞肺癌治療方案中加入Trilaciclib有助於減少部分患者的骨髓抑制及提升臨牀療效。
在聖安東尼奧乳腺癌研討會(SABCS)，G1 Therapeutics, Inc.報吿了Trilaciclib在轉移性三陰性乳腺癌(metastatic triple-negative breast cancer, mTNBC)臨牀中的最終草案。與單獨接受吉西他濱╱鉑類方案治療的患者相比，在化療方案中加入Trilaciclib可顯著延長mTNBC患者的總生存期。患者被隨機分配為僅接受吉西他濱╱鉑類方案(第1組)或吉西他濱╱鉑類方案加Trilaciclib(第2和3組)的兩種給藥方案之一。Trilaciclib和化療合用組(第2和3組)患者的中位生存期為19.8個月(HR=0.37,p<0.0001)，單獨接受化療患者組中位生存期為12.6個月。G1Therapeutics,Inc.正在計劃於2021年上半年啟動Trilaciclib在mTNBC中的關鍵性研究。
此前披露，公司與G1 Therapeutics, Inc.簽訂了一份許可及合作協議，根據該協議，公司被授予獨家使用G1 Therapeutics, Inc.的若干知識產權在大中華區開發和商業化Trilaciclib(口服劑型除外)。公司與G1Therapeutics,Inc.合作的創新藥注射用Trilaciclib於2021年1月18日獲得中國國家藥品監督管理局藥品評審中心簽發的藥物臨牀試驗批准通知書。
據悉，G1 Therapeutics, Inc.是一家商業階段的生物製藥公司，專注於發現、開發和交付旨在改善癌症患者生活的下一代療法，包括其首款商用產品COSELA™，一種旨在改善接受化學治療的患者的預後的首創療法。
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