药物名称drug：Tasurgratinib
CAS:1622204-21-0
API：tasurgratinib succinate
研发代号code：E-7090
批准上市时间approved：2024年9月24日（日本）
适应症To treat：治疗化疗后病情进展的、携带FGFR2基因融合或重排的不可切除胆道癌患者the treatment of unresectable FGFR2 fusion genepositive biliary tract cancer that has progressed after cancer chemotherapy.
原研公司Company：卫材Eisai
日本胆道癌患者人数约为 22000 人，五年相对生存率约为 25%。The number of patients with biliary tract cancer in Japan is about 22000, and the five-year relative survival rate is about 25%.
获批是基于卫材在日本和中国开展的一项多中心、开放性、单臂临床II期试验（NCT04238715）的结果。The approval is based on the results of a multicenter, open label, single arm phase II clinical trial (NCT04238715) conducted by Eisai in Japan and China.
结果：63例患者(日本人：n = 28；中国人：n = 35)接受治疗（中位年龄：55岁）；23名患者（37%）先前接受过1个方案，其他所有患者接受过≥2个方案。截至数据截止日期（2023年3月15日），55例患者停止治疗(疾病进展，n =48；不良事件，n = 4；患者选择，n = 2；临床获益损失，n = 1)。19名患者（30%）出现部分响应；31例（49%）有稳定的疾病， 13例（21%）有稳定的疾病≥23周。客观缓解率为30%(双侧90% CI 20.7-41.0；95% ci 19.2-43.0)；疾病控制率为79% (95% CI 67.3-88.5)；临床获益率为51% （95% CI 37.9-63.6）。应答者的中位响应时间 / 反应持续时间为1.87 mos (四分位数差为1.77-2.10；范围1.6 - 14.7)/ 5.6 mos (95% CI 3.7-9.3；范围1.0 + -14.8 +)。中位无进展生存期 / 总生存期为5.4 mos (95% CI3.7 - 5.6) / 13.1 mos （95% CI 10.8-17.4）。61名患者（97%）有≥1次治疗相关不良事件 (治疗相关不良事件)，最常见的是高磷血症(n = 51；81%);18例（29%）治疗相关不良事件≥1级，最常见的是脂肪酶升高(n = 4；6%)。34名患者（54%）减少剂量，18名患者（29%）因治疗相关不良事件而中断治疗。4名患者（6%）发生致命性不良事件，与治疗无关。
Results: 63 Pts (Japanese: n = 28; Chinese: n = 35) were treated (median age: 55 years); 23 pts (37%) had received 1 prior regimen, all others had received ≥ 2. By the data cutoff date (March 15, 2023), 55 pts discontinued treatment (disease progression, n = 48; adverse events, n = 4; pt choice, n = 2; loss of clinical benefit, n = 1). 19 Pts (30%) had a PR; 31 pts (49%) had SD and 13 (21%) had SD for ≥ 23 weeks. The ORR was 30% (2-sided 90% CI 20.7–41.0; 95% CI 19.2–43.0); the DCR was 79% (95% CI 67.3–88.5); the CBR was 51% (95% CI 37.9–63.6). The median [m]TTR / DOR for responders were 1.87 mos (IQR 1.77–2.10; range 1.6–14.7) / 5.6 mos (95% CI 3.7–9.3; range 1.0+–14.8+). The mPFS / OS were 5.4 mos (95% CI 3.7–5.6) / 13.1 mos (95% CI 10.8–17.4). 61 Pts (97%) had ≥ 1 treatment-related AE (TRAE), most commonly hyperphosphatemia (n = 51; 81%); 18 pts (29%) had ≥ 1 grade ≥ 3 TRAE, most commonly lipase increased (n = 4; 6%). 34 Pts (54%) had a dose reduction and 18 (29%) had treatment interruption due to TRAEs. 4 Pts (6%) had a fatal AE, none related to treatment.
参考文献ref:EP3184520
