復宏漢霖-Ｂ(02696.HK)在ASH年會公佈漢利康臨牀及羣體藥物代謝動力學研究進展
格隆匯12月9日丨復宏漢霖－Ｂ(02696.HK)發佈公告，近日，公司在第61屆美國血液學會(ASH)年會上，公佈了漢利康(HLX01，利妥昔單抗注射液)臨牀及羣體藥物代謝動力學(population pharmacokinetics, PopPK)的研究進展。
HLX01-NHL03是一項多中心、隨機化、雙盲、平行活性對照的3期臨牀試驗(NCT02787239)。納入臨牀試驗的407例CD20陽性瀰漫大B細胞淋巴瘤患者 1：1隨機分配接受HLX01或原研利妥昔單抗(中國市售)與原有化療藥物聯合治療。六個治療週期後的最佳總緩解率(best overall response rate, ORR6cycle)為主要療效終點。HLX01-RA01試驗共納入195例類風濕關節炎(RA)患者(HLX01組：97例；利妥昔單抗(歐洲市售)組：98例；血清樣本4289份)，主要終點為從0到趨近於無窮大的血藥濃度時間曲線下面積(AUC0-inf)。根據 HLX01-RA01試驗(NCT03355872)的藥代動力學(PK)數據，採用非線性混合效應模型(NONMEM?)以及考慮到交互作用的一級擬合方法(FOCEI)建立 PopPK模型。為評估藥代動力學(PK)與藥效學(PD)的相關性，重要協變量(如人口統計、病理生理╱疾病狀況等)被納入模型分析。基於篩選後的協變量，公司對模型進行了1000次模擬檢驗，然後使用110例DLCBL患者的PK數據對模型進行驗證，進一步與已發表的高加索人種藥代動力學數據進行了比較。
HLX01-NHL03結果顯示，HLX01組的ORR6cycle及其95%置信區間分別為 92.8%、(88.19%，96.00%)，原研利妥昔單抗(中國市售)的ORR6cycle及其 95%置信區間分別為94.1%、(89.77%，97.04%)，兩組ORR6cycle風險差為 1.4%，其95%置信區間(-3.59%，6.32%)落在了預設的等效區間(-12%， +12%)內。在HLX01-RA01研究中，HLX01與原研利妥昔單抗(歐洲市售)的 AUC0-inf幾何均數比值為104.32%，90%置信區間為(96.49%，112.80%)，在 80%-125%的藥代動力學生物等效性範圍內。藥代學動力模型為具有一級消除速率的二室模型。外部驗證結果顯示，基於RA患者建立的PopPK模型可以充分描述原研利妥昔單抗在DLBCL患者體內的血藥濃度，且HLX01與不同來源的利妥昔單抗藥代學特性相似。中國患者的藥代動力學參數也與已發表的高加索患者數據相似。
HLX01與原研利妥昔單抗(中國市售)在CD20陽性瀰漫大B細胞淋巴瘤的治療中呈現相似的療效和安全性。HLX01與原研利妥昔單抗(歐洲市售)在類風濕關節炎的治療中也呈現相似的藥代動力學特徵。羣體藥代動力學模型證實了HLX01在治療中與兩種不同來源的原研利妥昔單抗具有相似的藥代動力學特徵，在RA患者和DLBCL患者、不同種族患者中利妥昔單抗均呈現相似的藥代動力學特徵。
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