Avelumab + axitinib versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma: final analysis of the phase III JAVELIN Renal 101 trial.

We report the final analysis, including the primary analysis of overall survival(OS).

我们报告了最终分析结果，包括总生存（OS）的主要分析。

patients_and_methods

Patients with untreated aRCC (any prognostic risk score) were enrolled.

招募了未接受治疗的aRCC（任何预后风险评分）患者。

The primary endpoints were OS and PFS in the programmed death-ligand 1-positive (PD-L1+) population.

主要终点是程序性死亡配体1阳性（PD-L1+）人群中的总生存（OS）和无进展生存（PFS）。

ORR, duration of response, safety, and patient-reported outcomes (PROs) were also assessed.

客观缓解率（ORR）、反应持续时间、安全性和患者报告的结果（PROs）也得到了评估。

Results

The minimum follow-up was 68 months in all patients.

所有患者的最短随访时间为68个月。

The median OS with avelumab + axitinib versus sunitinib, respectively, was 43.2 months [95% confidence interval(CI) 36.5-51.7 months] versus 36.2 months (95% CI 29.8-44.2 months) in the PD-L1+ population [hazard ratio(HR) 0.86 (95% CI 0.701-1.057); P = 0.0755] and 44.8 months (95% CI 39.7-51.1 months) versus 38.9 months (95% CI 31.4-45.2 months) in the overall population [HR 0.88 (95% CI 0.749-1.039); P = 0.0669].

在PD-L1+人群中，avelumab+axitinib与sunitinib的中位总生存期分别为43.2个月[95%置信区间（CI）36.5-51.7个月]和36.2个月（95% CI 29.8-44.2个月）[风险比（HR）0.86（95% CI 0.701-1.057）；P = 0.0755]；在整体人群中，分别为44.8个月（95% CI 39.7-51.1个月）和38.9个月（95% CI 31.4-45.2个月）[HR 0.88（95% CI 0.749-1.039）；P = 0.0669]。

Investigator-assessed PFS remained prolonged with avelumab + axitinib versus sunitinib [5-year event-free rate in the overall population, 12.0% (95% CI 8.9% to 15.6%) versus 4.4% (95% CI 2.5% to 7.3%)].

研究者评估的无进展生存期（PFS）在avelumab+axitinib与sunitinib治疗中仍然延长[整体人群中5年无事件生存率为12.0%（95% CI 8.9%至15.6%）对比4.4%（95% CI 2.5%至7.3%）]。

ORR in the overall population was 59.7% (95% CI 55.0% to 64.3%) with avelumab + axitinib versus 32.0% (95% CI 27.7% to 36.5%) with sunitinib; duration of response was ≥5 years in 16.4% (95% CI 12.0% to 21.4%) versus 9.2% (95% CI 4.6% to 15.7%), respectively.

在整体人群中，avelumab联合axitinib的客观缓解率(ORR)为59.7%（95%置信区间55.0%至64.3%），而sunitinib为32.0%（95%置信区间27.7%至36.5%）；反应持续时间≥5年的比例分别为16.4%（95%置信区间12.0%至21.4%）和9.2%（95%置信区间4.6%至15.7%）。

Rates of grade ≥3 treatment-related adverse events were 66.8% versus 61.5%, respectively.

3级及以上治疗相关不良事件的发生率分别为66.8%和61.5%。

PROs were similar between arms.

各组之间的患者报告结果（PROs）相似。

Conclusions

JAVELIN Renal 101 provides the longest follow-up to date for immune checkpoint inhibitor+ tyrosine kinase inhibitor combination treatment from a phase III trial in aRCC.

JAVELIN Renal 101提供了迄今为止从III期试验中免疫检查点抑制剂加酪氨酸激酶抑制剂联合治疗晚期肾细胞癌（aRCC）中最长的随访数据。

OS analyses favored avelumab + axitinib versus sunitinib but did not reach statistical significance; subsequent treatment may have impacted results.

总生存分析倾向于avelumab + axitinib与sunitinib相比，但未达到统计学显著性；后续治疗可能影响了结果。

Avelumab + axitinib provided long-term efficacy benefits versus sunitinib, including prolonged PFS, a nearly doubled ORR, and more durable responses, with a manageable long-term safety profile.

Avelumab + axitinib与sunitinib相比，提供了长期疗效优势，包括延长无进展生存期（PFS），几乎翻倍的客观缓解率（ORR），以及更持久的反应，且长期安全性可控。