復宏漢霖-Ｂ(02696.HK)公佈HLX04最新臨牀研究數據
格隆匯 9 月 20日丨復宏漢霖-Ｂ(02696.HK)宣佈，近日，公司於第23屆全國臨牀腫瘤學大會暨2020年CSCO學術年會上以口頭報告形式發佈了HLX04(重組抗VEGF人源化單克隆抗體注射液)("HLX04")的最新臨牀研究數據。
一項比較HLX04或貝伐珠單抗聯合奧沙利鉑和氟尿嘧啶類為基礎的化療(XELOX或mFOLFOX6)方案一線治療轉移性結直腸癌(mCRC)的3期臨牀試驗
(A)試驗設計
HLX04-mCRC03是一項多中心、隨機、雙盲、平行對照的3期臨牀試驗(臨牀試驗號：NCT03511963)，旨在比較HLX04或原研貝伐珠單抗聯合化療方案(XELOX方案或mFOLFOX6方案)一線治療轉移性結直腸癌的療效、安全性和免疫原性。納入的患者按照1:1的比例隨機分為兩組，分別靜脈注射HLX04或原研貝伐珠單抗(聯合XELOX時每三週注射一次，劑量為7.5mg/kg，聯合mFOLFOX6時每兩週注射一次，劑量為5mg/kg)。主要療效終點為36周的無進展生存率(PFSR36w)。
(B)試驗結果
1)有效性
a)主要終點
本試驗入組了675例病患(HLX04組，N=338；原研組，N=337)。在全分析集(FAS)中，HLX04組和原研組的PFSR36wk分別為46.4%和50.7%。兩組率差為-4.2%(90%置信區間：-10.6%，2.1%)，落於預先設定的等效界值(-11%，15%)範圍之內，證明HLX04和原研貝伐珠單抗的療效相似性。
b)次要終點
兩治療組的次要療效終點如總生存期(OS)、無進展生存期(PFS)、客觀緩解率(ORR)、至緩解時間(TTR)、緩解持續時間(DoR)等，均無統計學差異(p>0.05)。
2)安全性及免疫原性
HLX04和原研貝伐珠單抗的安全性和免疫原性特徵相似。
(C)結論
3期臨牀試驗結果顯示，HLX04與原研貝伐珠單抗在一線治療轉移性結直腸癌患者時，療效、安全性和免疫原性特徵相當。HLX04作為生物類似藥候選藥將為癌症患者帶來更多治療選擇。
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