May 29, 2020
ASCO:更新的靶向治疗的临床试验结果继续显示出对晚期结直肠癌和膀胱癌预后改善
BY Kelly Calagna
Updated results from two MD Anderson临床试验在介绍2020 American Society of Clinical Oncology (ASCO) Annual Meetingindicate improved outcomes for cancer patients with specific gene mutations when treated withtargeted therapies。来自信标CRC和BLC2001临床试验的靶向治疗药物导致的治疗FDA批准的具有先进的患者亚群colorectaland膀胱癌。
Encorafenib plus cetuximab with or without binimetinib for BRAF V600E metastatic colorectal cancer: Updated survival results from a randomized, three-arm, Phase III study versus choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC) (abstract4001)
Updated results of theBEACON CRC三期临床试验表明,该治疗方案of encorafenib plus cetuximab had similar outcomes to the study’s three-drug combination of encorafenib, cetuximab and binimetinib in patients with BRAF-mutated metastaticcolorectal cancer(转移性结直肠癌)。
Both regimens are well-tolerated and are shown to significantly improve patients’ overall survival, overall response rate and progression-free survival. While additional research is needed into the potential added benefits of using the triplet therapy with binimetinib, exploratory analysis indicates that some patient populations may benefit from the addition.
Last month, encorafenib plus cetuximab earnedFDA approvalas a treatment for adult patients with mCRC and the BRAF V600E mutation. BEACON CRC is the first and only Phase III clinical trial designed to test combination targeted therapies in patients with mCRC and the BRAF V600E mutation, which occurs in 10% to 15% of mCRC patients and is marked with poor prognosis.
护理治疗的标准有5.4个月,中位总生存期,而双和三重疗法既提高了中位总生存率9.3个月。此外,总反应率为用于encorafenib加上西妥昔单抗和三重疗法包括binimetinib 27%20%,相比之下,只有2%的标准疗法。
“该encorafenib加上西妥昔单抗治疗方案应该是照顾大多数患者以前治疗过BRAF V600E突变的转移性结直肠癌的新标准,”首席研究员Scott Kopetz, M.D., associate professor of胃肠道肿瘤内科。“这个方案也可以作为一个合适的骨干评估除了其他靶向药物和/或化疗。”
ERDAFITINIB局部晚期或转移性尿路上皮癌(MUC):在BLC2001的远期疗效(摘要5015)
之后的中位数两年的随访BLC2001 Phase IIclinical trial, treatment with the oral FGFR inhibitor erdafitinib (ERDA) showed consistent efficacy among patients with locally advanced or metastatic urothelial cancers and FGFR gene mutations.
该study是为患者在FGFR3基因的突变,这是目前在患有转移性膀胱癌约15%至20%的突破。
For decades, the standard treatment for these cancers has been an aggressive regimen of cisplatin-basedchemotherapy— an intensely powerful medication that comes with significant side effects. In recent years, new checkpoint blockade inhibitors have been approved, however, the response to theseimmunotherapies只有约15%至20%。
平均两年的随访,治疗a median OS of 11.3 months and an objective tumor response rate of 40%. Additionally, 12- and 24-month survival rates were 49% and 31%, respectively, with 31% of patients having responses longer than one year.
Treatment with ERDA, which last year became the firstFDA批准对于患有转移性膀胱癌靶向治疗,一直是很好的耐受性,可以为患者提供后以前的治疗均未能工作或不能再容忍一个新的选择。ERDA在为谁免疫以前失败的患者亚组出现有效。
“随着erdafitinib的批准,第一一流FGFR3抑制剂,我们现在可以考虑我们的尿路上皮癌患者的治疗个体化治疗,”首席研究员Arlene Siefker-Radtke, M.D.,教授泌尿生殖系统肿瘤内科。“我们正在探索一个FGFR3是否改变尿路上皮癌的好处更多从erdafitinib或III期临床试验检查点抑制剂,THOR,并结合erdafitinib在随机试验NORSE检查点抑制剂,以更好地对待我们的FGFR3改变尿路上皮癌患者。”
这些研究的合着者和披露的全部信息,请访问hereandhere。