LBA96 Roxadustat for chemotherapy-induced anemia in patients with non-myeloid malignancies: A randomized, open-label, active-controlled, phase III study
LBA96 Roxadustat 用于非骨髓恶性肿瘤患者化疗诱导的贫血：一项随机、开放标签、活性对照、III 期研究

Chemotherapy-induced anemia (CIA) is a common complication of cancer and an important risk factor leading to poor prognosis for patients. Recombinant human erythropoietin-α (rHuEPO-α) is standard of care for CIA; however, safety concerns remain. Roxadustat is the first hypoxia-inducible factor prolyl hydroxylase inhibitor approved for treatment of anemia in chronic kidney disease. This study evaluated the efficacy and safety of roxadustat for anemia in patients with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.
化疗诱导的贫血（CIA）是癌症的常见并发症，也是导致患者预后不佳的重要风险因素。重组人重组人红细胞生成素-α（rHuEPO-α）是 CIA 的标准治疗方法；然而，安全性仍然存在疑虑。罗沙度司他是首个获批用于治疗慢性肾脏疾病贫血的缺氧诱导因子脯氨酸羟化酶抑制剂。本研究评估了罗沙度司他对非髓系恶性肿瘤患者贫血的疗效和安全性，这些患者接受多周期骨髓抑制化疗治疗。

In this open-label, non-inferiority, multicenter Phase III study conducted in China, patients were randomized (1:1) to receive oral roxadustat or subcutaneous rHuEPO-α three times weekly (TIW) for 12 weeks. Roxadustat starting dosage was 100 mg, 120 mg, and 150 mg TIW (patients weighing 40‒<50, 50–60, and >60 kg). rHuEPO-α starting dosage was 150 IU/kg TIW. Both roxadustat and rHuEPO-α dosages could be modified to achieve hemoglobin (Hb) concentrations of 100–120 g/L. Primary efficacy endpoint was least-squares mean (LSM) change in Hb concentration from baseline to the concentration averaged over Weeks 9‒13. Adverse events (AEs) were monitored.
在中国进行的这项开放标签、非劣效性、多中心第三期研究中，患者被随机分配（1:1）接受口服罗沙司他或皮下注射重组人促红细胞生成素α（rHuEPO-α）每周三次（TIW）治疗 12 周。罗沙司他的起始剂量为 100 毫克、120 毫克和 150 毫克 TIW（患者体重为 40‒<50、50–60 和>60 千克）。rHuEPO-α的起始剂量为每周 150 国际单位/千克。罗沙司他和 rHuEPO-α的剂量可以调整以达到血红蛋白（Hb）浓度为 100–120 克/升。主要疗效终点是基线至第 9‒13 周平均浓度的血红蛋白浓度的最小二乘均值（LSM）变化。监测不良事件（AEs）。

Of 159 patients randomized (n=82, roxadustat; n=77, rHuEPO-α), 140 were included in the per protocol set (n=78, roxadustat; n=62, rHuEPO-α). The LSM (95% 2-sided confidence interval [CI]) change from baseline to Weeks 9‒13 in Hb concentration was 17.1 (13.58, 20.71) g/L with roxadustat and 15.4 (11.34, 19.50) g/L with rHuEPO-α. The lower bound of the 1-sided 97.5% CI for the treatment difference (‒3.4 g/L) was greater than the predefined non-inferiority margin of ‒6.6 g/L, establishing non-inferiority. Results were supported by key secondary endpoints. AE rates were generally comparable between treatments and consistent with previous findings, supporting a positive benefit-risk profile.
在随机分配的 159 名患者中（n=82，罗沙司他；n=77，rHuEPO-α），共有 140 名患者被纳入符合方案集（n=78，罗沙司他；n=62，rHuEPO-α）。LSM（95%双侧置信区间[CI]）基线至第 9-13 周 Hb 浓度变化为罗沙司他 17.1（13.58，20.71）g/L，rHuEPO-α为 15.4（11.34，19.50）g/L。治疗差异（-3.4 g/L）的单侧 97.5% CI 的下限大于预定义的-6.6 g/L 的非劣效边界，证实了非劣效性。结果得到关键次要终点的支持。不良事件发生率在治疗间基本可比，并与先前的发现一致，支持积极的利弊风险概况。

Oral roxadustat was non-inferior to subcutaneous rHuEPO-α for anemia in patients with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.
口服罗沙司他对接受多周期骨髓抑制化疗治疗的非髓样恶性肿瘤患者贫血的非劣效性不逊于皮下重组人促红细胞生成素α。

FGCL-4592-898. FGCL-4592-898。

Marjet Heitzer, PhD, Kay Square Scientific, Newtown. Square, PA
马杰特·海泽（Marjet Heitzer），博士，凯广场科学（Kay Square Scientific），纽敦广场，宾夕法尼亚州。

FibroGen, Inc. 斐博基因公司

FibroGen, Inc. 斐博基因公司

S. Lu: Financial Interests, Speaker, Consultant, Advisor, speaker fees, advisor/consultant: AstraZeneca; Financial Interests, Speaker, Consultant, Advisor, speaker fees: Hansoh, Hengrui Therapeutics; Financial Interests, Speaker, Consultant, Advisor, advisor/consultant: Pfizer, Boehringer Ingelheim, Hutchison, ZaiLab, GenomiCare, Yuhan Corporation, Menarini, InventisBio Co., Simcere Zaiming, Roche; Financial Interests, Research Funding, research support: AstraZeneca, Hutchison, BMS, Heng Rui, BeiGene, Roche, Hansoh, Lilly Suzhou, Fibrogen. J. Wu: Financial Interests, Advisory Role: AstraZeneca, Roche, Novartis, Heng Rui, Lilly, FibroGen; Financial Interests, Other, consultant: AstraZeneca, Roche, Novartis, Heng Rui, Lilly, FibroGen. J. Jiang: Financial Interests, Research Funding: Heng Rui, Roche, Alphamab Oncology, FibroGen. Q. Guo: Financial Interests, Advisory Role: AstraZeneca, Roche, Novartis, Heng Rui, Lilly, FibroGen; Financial Interests, Other, consultant: AstraZeneca, Roche, Novartis, Heng Rui, Lilly, FibroGen. Y. Liu: Financial Interests, Speaker, Consultant, Advisor: Xinda, BeiGene, Roche, Hengrui Therapeutics, AstraZeneca, Qilu, BMS, Roche; Financial Interests, Research Funding: AstraZeneca, BeiGene, Roche, FibroGen. H. Zhang: Financial Interests, Advisory Role: AstraZeneca, Roche, Pfizer, Heng Rui, BMS, BeiGene, Roche, Innovent; Financial Interests, Other, consultant: AstraZeneca, Pfizer, Heng Rui, BMS, BeiGene, Roche, Innovent; Financial Interests, Officer, consultant: Roche. L. Qian: Financial Interests, Research Funding: GSK Plc, Sanofi, Mundi Pharma, Hutchison Whampoa Limited (HWL), Dalian Wanchun Biotechnology Co., Ltd., Shanghai Lunsheng Pharmaceutical Technology Co., Ltd., Innovent (Suzhou), FibroGen. X. Dai: Financial Interests, Research Funding: Luye Pharma, FibroGen. Y. Xie: Financial Interests, Other, speaker fees: AstraZeneca, Roche, Heng Rui, Lilly, Pfizer, MSD, Simcere, FibroGen. T. Fu: Financial Interests, Advisory Role: Heng Rui, Ji Shi, FibroGen; Financial Interests, Other, consultant: Heng Rui, Ji Shi, FibroGen. T. Lee, Y. Lu, R. Ma, M. Eisner: Financial Interests, Full or part-time Employment: FibroGen; Financial Interests, Stocks or ownership: FibroGen.. All other authors have declared no conflicts of interest.
卢 S：财务利益，演讲者，顾问，顾问，演讲费用，顾问/顾问：阿斯利康；财务利益，演讲者，顾问，顾问，演讲费用：汉森，恒瑞治疗；财务利益，演讲者，顾问，顾问，顾问/顾问：辉瑞，勃林格殷格翰，和记，ZaiLab，基因美康，裕晏公司，美纳林，英飞拓生物有限公司，先声再明，罗氏；财务利益，研究资助，研究支持：阿斯利康，和记，BMS，恒瑞，北极星，罗氏，汉森，莱利苏州，费博基因。吴 J：财务利益，咨询角色：阿斯利康，罗氏，诺华，恒瑞，莱利，费博基因；财务利益，其他，顾问：阿斯利康，罗氏，诺华，恒瑞，莱利，费博基因。江 J：财务利益，研究资助：恒瑞，罗氏，阿法马肿瘤，费博基因。郭 Q：财务利益，咨询角色：阿斯利康，罗氏，诺华，恒瑞，莱利，费博基因；财务利益，其他，顾问：阿斯利康，罗氏，诺华，恒瑞，莱利，费博基因。Y. 刘：财务利益，发言人，顾问，顾问：新达，北基因，罗氏，恒瑞医药，阿斯利康，齐鲁，百时美施贵宝，罗氏；财务利益，研究资助：阿斯利康，北基因，罗氏，菲柏根。张：财务利益，咨询角色：阿斯利康，罗氏，辉瑞，恒瑞，百时美施贵宝，罗氏，信达；财务利益，其他，顾问：阿斯利康，辉瑞，恒瑞，百时美施贵宝，罗氏，信达；财务利益，官员，顾问：罗氏。钱：财务利益，研究资助：葛兰素史克股份有限公司，赛诺菲，明迪制药，和记黄埔有限公司，大连万春生物科技有限公司，上海伦生制药技术有限公司，信达（苏州），菲柏根。戴：财务利益，研究资助：庐业制药，菲柏根。谢：财务利益，其他，演讲费：阿斯利康，罗氏，恒瑞，礼来，辉瑞，默沙东，先声，菲柏根。付：财务利益，咨询角色：恒瑞，吉士，菲柏根；财务利益，其他，顾问：恒瑞，吉士，菲柏根。李，陆，马，艾斯纳：财务利益，全职或兼职雇佣：菲柏根；财务利益，股票或所有权：菲柏根。 所有其他作者均声明没有利益冲突。