金斯瑞生物科技(01548.HK)：接受西達基奧侖賽治療患者對比RWCP組患者展示出顯著提高的客觀緩解率和總生存期
格隆匯12月13日丨金斯瑞生物科技(01548.HK)公吿，公司非全資附屬公司傳奇生物科技股份有限公司（傳奇生物）於2021年12月13日宣佈了CARTITUDE臨牀開發項目研究西達基奧侖賽(cilta-cel)治療多發性骨髓瘤的最新數據，這些結果已在2021年第63屆美國血液學會(ASH)年會上發佈。西達基奧侖賽是一款在研的靶向B細胞成熟抗原(BCMA)嵌合抗原受體T細胞(CAR-T)療法，用於骨髓瘤的一次性治療。
口頭報吿（第549號摘要）中提到，在對97名復發或難治性多發性骨髓瘤(RRMM)患者進行的1b/2期CARTITUDE-1研究的長期結果中，繼續顯示高達98%客觀緩解率(ORR)。在21.7個月的隨訪後，83%的接受西達基奧侖賽治療的患者達到了嚴格意義的完全緩解(sCR)，高於中位數約1年隨訪時報吿的67%sCR。而且，95%的患者獲得了非常好的部分緩解(VGPR)及以上。中位無進展生存期(PFS)和中位總生存期(OS)尚未達到，不過2年無進展生存率(PFS)為61%(95%CI，48.5–70.4)，2年總體生存率(OS)為74%(95%CI，61.9–82.7)。在61名微小殘留病灶(MRD)可評估的患者中，92%的患者呈現10–5MRD陰性，6個月以上及12個月以上持續MRD陰性患者的2年無進展生存率(PFS)分別為91%(95%CI，67.1–97.8)和100%。
首次緩解的中位時間為一個月（範圍為0.9–10.7），最佳緩解的中位時間為2.6個月（範圍為0.9–17.8）；完全緩解及以上的中位時間為2.9個月（範圍為0.9–17.8）。長期隨訪資料未觀察到新的安全信號，自1年左右中位隨訪以來，未發生新的與西達基奧侖賽相關的神經毒性事件和治療期間出現的運動和神經認知不良事件(TEAEs)(MNT)。在CARTITUDE臨牀開發項目中，採取緩解措施已使相關不良事件發生率降至0.5%。
此外，口頭報吿（摘要#550）中也介紹了CARTITUDE-1治療與真實世界臨牀研究(RWCP)標準治療的調整後間接對比。針對CARTITUDE-1的調整後對比研究中，接受西達基奧侖賽治療患者對比RWCP組患者展示出顯著提高的客觀緩解率(ORR)、完全緩解及以上(≥CR)、非常好的部分緩解(≥VGPR)、無進展生存期(PFS)和總生存期(OS)。
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