Introduction: The incidence of advanced renal cell carcinoma (RCC) is increasing. Over the last 10 years targeted therapies have led to improved efficacy outcomes for renal carcinoma, including longer survival. However, the majority of patients develop disease progression within a year of initiation of first-line therapy. Recently a number of new regimens have been investigated including the combination of immune checkpoint inhibitors with VEGF inhibitors.Areas covered: In this review, we assess the efficacy and safety of avelumab/axitinib in treatment-naïve patients with metastatic RCC and compare this combination to other current and emerging treatment regimens. In the Javelin 101 phase III registration trial, avelumab/axitinib demonstrated superior response rates and progression-free survival compared to sunitinib. However, after follow-up of 11.6 months, there was no significant difference in overall survival (OS). Avelumab/axitinib showed a tolerable safety profile. Adverse events were manageable and were in line with expected toxicities from the single agents.Expert Opinion: Avelumab/axitinib has shown impressive efficacy and a tolerable safety profile in metastatic RCC. The future role of this treatment combination in the rapidly evolving landscape of novel combinations in this disease will have to be defined.

中文翻译：

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Avelumab和axitinib在治疗肾细胞癌中的安全性和有效性。

简介：晚期肾细胞癌（RCC）的发病率正在增加。在过去的十年中，靶向疗法已导致肾癌的疗效改善，包括更长的生存期。但是，大多数患者在开始一线治疗后的一年内出现疾病进展。最近研究了许多新方案，包括免疫检查点抑制剂和VEGF抑制剂的联合使用。研究范围：在本综述中，我们评估了avelumab / axitinib在未经治疗的转移性RCC患者中的疗效和安全性，并将这种组合与其他目前和新兴的治疗方案。在Javelin 101 III期注册试验中，与sunitinib相比，avelumab / axitinib表现出更高的缓解率和无进展生存期。然而，在11.6个月的随访中，总生存期（OS）没有显着差异。Avelumab /阿昔替尼显示出可耐受的安全性。不良事件是可控制的，并且与单一药物的预期毒性相符。专家意见：Avelumab / axitinib在转移性RCC中显示出令人印象深刻的疗效和可耐受的安全性。在这种疾病的新型组合迅速发展的前景中，必须确定这种治疗组合的未来作用。