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Opdivo+Yervoy一线治疗晚期肾细胞癌显示30个月长期生存获益

医药魔方 医药魔方 来源:医药魔方
2019-02-12
Opdivo+Yervoy 晚期肾细胞癌 百时美施贵宝
原文

BMS 2月11日宣布了III期CheckMate -214研究的最新结果。Opdivo (nivolumab) 联合低剂量Yervoy (ipilimumab) 对于未接受过治疗的晚期或转移性肾细胞患者在30个月的中位随访期时相比舒尼替尼治疗组显著改善OS。并且在30个月时,Opdivo联合低剂量Yervoy在中等-高风险人群中的ORR与之前17.5个月时分析相比有所改善。


CheckMate- 214是一项随机、开放的III期研究,评估Nivolumab联合Ipilimumab方案对比舒尼替尼用于初治晚期或转移性肾细胞癌 (RCC)患者的情况。联合组的患者接受Nivolumab 3mg/kg联合Ipilimumab 1mg/kg,每3周1次,连续用药4个周期后序贯Nivolumab 3mg/kg,每2周1次单药Opdivo;对照组患者接受舒尼替尼 50mg,每天1次,连续用药4周,休息2周,再继续下一周期。两组患者均连续用药直至疾病进展或出现不可耐受的毒性。主要研究终点为中等-高风险人群(约占患者的75%)的总生存期(OS)、无进展生存期(PFS)和客观缓解率(ORR)。结果显示:


ORR:接受Opdivo联合低剂量Yervoy,ORR达到42%;舒尼替尼组ORR为29%(p=0.0001)。超过一半(52%)对Opdivo联合低剂量Yervoy有反应,其中中等-高风险患者的反应至少持续18个月,28%的患者对舒尼替尼有反应。


完全反应(CR):接受Opdivo联合低剂量Yervoy的CR率为11%,舒尼替尼组CR率为1%。


接受Opdivo联合低剂量Yervoy的意向治疗(ITT,即所有随机化)人群的结果相似,同样得到显著改善:


OS:接受Opdivo联合低剂量Yervoy治疗的患者,ITT人群的30个月OS率为64%,而接受舒尼替尼治疗的患者OS率为56%[HR=0.71(95%CI:0.59,0.86);p= 0.0003]。


ORR:接受Opdivo联合低剂量Yervoy治疗的患者,ITT人群的ORR达到41%,舒尼替尼为34%(p=0.015)。


CR:接受Opdivo联合低剂量Yervoy治疗的患者,ITT人群的CR率达到11%,而舒尼替尼CR率为2%。


同时,接受Opdivo联合低剂量Yervoy治疗在30个月的总体安全性与17.5个月的最小随访分析和之前报道的RCC患者中的研究结果一致。延长随访时未发生新的安全性信号或与药物有关的死亡。


“来自CheckMate -214研究的30个月随访结果是有意义的,因为它们继续证明在患有晚期肾细胞癌的患者中,有大量未满足治疗需求的人群,接受Opdivo联合Yervoy治疗有可能实现长期生存获益。“CheckMate -214试验的研究员、MD安德森癌症中心癌症医学系泌尿外科肿瘤科Nizar M. Tannir博士表示。


“我们很高兴CheckMate -214的结果继续提供临床证据,表明Opdivo和Yervoy联合可以延长某些晚期肾细胞癌患者的生存期,”BMS黑色素瘤和泌尿生殖系统肿瘤开发主管Arvin Yang博士表示, “这些后续数据强化了我们的科学方法,并不断致力于提供治疗方案,帮助患有这种无情疾病的患者延长寿命。”


这些数据将于2019年2月16日在旧金山举行的2019年美国临床肿瘤学会泌尿生殖系统癌症研讨会(ASCO-GCS)上以口头报告(摘要#547)展示。


机器翻译

BMS announced the latest results of the Phase III CheckMate -214 study on February 11.Opdivo (nivolumab) in combination with low-dose Yervoy (ipilimumab) significantly improved OS compared with sunitinib in patients with untreated advanced or metastatic renal cells at a median follow-up of 30 months.And at 30 months, the ORR of OPDIVO in combination with low-dose YERVOY in the intermediate-high risk population was similar to the previous 17.The analysis was improved at 5 months.

CheckMate- 214 is a random.Open-label phase III study evaluating nivolumab plus ipilimumab versus sunitinib in treatment-naive patients with advanced or metastatic renal cell carcinoma (RCC).Patients in the combination group received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks, followed by sequential nivolumab 3 mg/kg every 2 weeks for 4 cycles followed by single-agent Opdivo; patients in the control group received sunitinib 50 mg once daily for 4 weeks followed by 2 weeks of rest before continuing in the next cycle.Both groups were treated continuously until disease progression or intolerable toxicity.The primary study endpoint was overall survival (OS) in the intermediate-high risk population (approximately 75% of patients).Progression-free survival (PFS) and objective response rate (ORR).The results showed:

ORR: ORR was 42% in the group receiving OPDIVO in combination with low-dose YERVOY; ORR was 29% in the sunitinib group (p = 0.0001).More than half (52%) responded to OPDIVO in combination with low-dose YERVOY, with responses lasting at least 18 months in intermediate-high risk patients and 28% responding to sunitinib.

Complete Response (CR): The CR rate was 11% with OPDIVO plus low-dose YERVOY and 1% with sunitinib.

The results were similar and significantly improved in the intent-to-treat (ITT, i.e., all randomized) population receiving OPDIVO in combination with low-dose YERVOY:

OS: In patients receiving OPDIVO in combination with low-dose YERVOY, the OS rate at 30 months was 64% in the ITT population compared with 56% in patients receiving sunitinib [HR = 0.71 (95% CI: 0.59, 0.86); p = 0.0003].

ORR: In patients treated with OPDIVO in combination with low-dose YERVOY, the ORR was 41% in the ITT population and 34% with sunitinib (p = 0.015).

CR: In patients treated with OPDIVO in combination with low-dose YERVOY, the CR rate in the ITT population was 11%, while the CR rate with sunitinib was 2%.

At the same time, the overall safety of receiving OPDIVO in combination with low-dose YERVOY at 30 months was similar to 17.The minimal follow-up analysis at 5 months was consistent with previously reported results in patients with RCC.There were no new safety signals or drug-related deaths with extended follow-up.

"The 30-month follow-up results from the CheckMate -214 study are meaningful because they continue to demonstrate that in patients with advanced renal cell carcinoma, there is a substantial unmet treatment need in a population where long-term survival benefit may be achieved with OPDIVO plus YERVOY."Researchers in the CheckMate -214 trial.Nizar M., Department of Urological Oncology, Department of Cancer Medicine, MD Anderson Cancer Center.Dr. Tannir said.

"We are pleased that the results of CheckMate -214 continue to provide clinical evidence that the combination of Opdivo and Yervoy can prolong survival in some patients with advanced renal cell carcinoma," said Dr. Arvin Yang, Head of Melanoma and Urogenital Tumor Development at BMS.

These data will be presented in an oral presentation (abstract 547) at the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO-GCS) 2019, San Francisco, February 16, 2019.

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