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最近因为疫情，很多事情的敏感度都变低了，在这里希望大家和家人做好日常防护。今天也是毫不情愿的刷了GI20，也没什么太亦可赛艇之处。 1 NIVO + CABO +/- IPI治疗晚期HCC https://meetinglibrary./record/182805/abstract 这里的晚期HCC包括未经过或已经索拉非尼治疗的患者，分配至NIVO 240 mg Q2W + CABO 40 mg QD及 NIVO 3 mg/kg Q2W + IPI 1 mg/kg Q6W + CABO 40 mg QD组，主要终点研究者评估的ORR及安全性和可耐受性。 疗效方面：ORR 17%和26%，DCR 81%和83%，PFS 5.5mo和6.0mo，OS两组均NR。但是安全性方面：Gr 3-4 TRAEs分别42%和71%，因此引起的治疗终止3%和20% 疗效谈不上惊艳，安全性实在。。。有兴趣的可以翻下Nivo+CABO在RCC的结果，也是安全性这么坑 2 Veliparib+GC vs GC in (g)BRCA/ PALB2m PDAC https://meetinglibrary./record/182808/abstract PDAC中BRCA突变5-8%，Ph1中Veli+GC的ORR 78%，这里开了Ph2对照来评估下联合的疗效，主要终点ORR 结果： Veli+GC组的血液毒性更高，Gr3-4的中性粒细胞减少、血小板减少和贫血分别48% vs 30%、55% vs 9%、52% vs 35%，非血液毒性接近。 疗效：咋圆？ 3 JAVELIN Gastric 100 phase 3：GC/GEJC一线化疗后avelumab vs 安慰剂的维持 https://meetinglibrary./record/182260/abstract LA/M的HER2− GC/GEJC患者在接受12wks的一线奥沙利铂+氟尿嘧啶的诱导化疗后随机切换至avelumab或继续化疗方案，主要终点是全部及PD-L1+患者在诱导后的OS 855pts接受诱导化疗后499pts分别随机分配之ave组和化疗组，随访18mo后OS 10.4 vs 10.9 mo(HR 0.91)，2y OSR 22.1% vs 15.5%。而PD-L1+患者的OS的HR 1.13。在亚洲患者(HR 0.90)及其他亚组中均未观察到OS获益趋势。 两组PFS相似 HR 1.04，而ORR 13.3% vs 14.4%，1y DOR 62.3% vs 28.4% 任意级别的TRAE 61.3% vs 77.3%，其中Gr>3的TRAE 12.8% vs 32.8% 结论：略 4 【方案】FIGHT-302：Pemigatinib VS GC一线治疗FGFR2融合或重排的胆管癌 https://meetinglibrary./record/182260/abstract Background:For advanced CCA, standard of care 1L systemic treatment is GEM + CIS. Genetic alterations in intrahepatic CCA provide potential therapeutic targets. Fibroblast growth factor receptor (FGFR) 2 gene rearrangements driving CCA tumorigenesis were identified almost exclusively in intrahepatic CCA patients (pts) (incidence, 10–16%). In phase 2, PEM (INCB054828), a selective, potent, oral FGFR1–3 inhibitor elicited an objective response rate (ORR) of 35.5% and median progression-free survival (PFS) of 6.9 months (mo) in previously treated, locally advanced or metastatic CCA with FGFR2 rearrangements (NCT02924376). FIGHT-302, a randomized, open-label, phase 3 study will evaluate efficacy and safety of 1L PEM vs GEM + CIS in unresectable/metastatic CCA with FGFR2 fusions or rearrangements (NCT03656536).Methods:Eligible pts are adults with confirmed unresectable/metastatic CCA; no prior systemic therapy for advanced disease < 6 mo before enrollment; radiographically measurable/evaluable disease (per RECIST v1.1); ECOG PS ≤1; documented FGFR2 fusions or rearrangements. Exclusions include clinically significant corneal or retinal disorder; history of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic soft tissue calcification; untreated CNS metastases or history of uncontrolled seizures. Pts will be randomized (1:1; stratified by region and tumor burden) to PEM 13.5 mg QD on a 21-day (d) cycle or GEM (1000 mg/m2) + CIS (25 mg/m2) on D1 and D8 of 21-d cycles (max 8). Crossover to PEM allowed after confirmed progression. PEM titration to 18 mg from cycle 2 allowed for pts without hyperphosphatemia (serum phosphate > 5.5 mg/dL) and Grade ≥2 treatment-related adverse events during cycle 1. Hyperphosphatemia will be managed with diet modifications, phosphate binders, diuretics, or dose adjustments. Treatment will continue until progression or unacceptable toxicity. Primary endpoint is PFS (by independent review). Secondary endpoints are ORR, overall survival, duration of response, disease control rate, safety, and quality of life. Four pts (target N = 432) are enrolled as of Sep 25, 2019. Clinical trial information: NCT03656536 |
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