ALBAN (GETUG-AFU 37): a phase III, randomized, open-label international trial of intravenous atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) versus BCG alone in BCG-naive high-risk, non-muscle-invasive bladder cancer (NMIBC).

Prior studies suggest that programmed death-ligand 1 (PD-L1) expression and alterations in immune infiltration might be associated with BCG failure.

先前的研究表明，程序性死亡配体1（PD-L1）的表达和免疫浸润的改变可能与BCG治疗失败有关。

patients_and_methods

The ALBAN trial is an international, 1 : 1 randomized, open-label phase III trial comparing the combination of atezolizumab (an anti-PD-L1 antibody) and BCG (arm B) versus BCG alone (arm A) for BCG-naive patients with high-risk NMIBC.

ALBAN试验是一项国际性的1:1随机、开放标签的III期临床试验，比较了阿替利珠单抗（一种抗PD-L1抗体）与BCG联合治疗（B组）与仅使用BCG治疗（A组）对于BCG未经治疗的高危非肌层浸润性膀胱癌患者的疗效。

The primary endpoint was investigator-assessed event-free survival (EFS).

主要终点是研究者评估的无事件生存（EFS）。

Key secondary endpoints included high-grade recurrence-free survival, complete response rate, and duration of response in patients with carcinoma in situ disease, as well as overall survival.

主要次要终点包括高级别无复发生存率、完全缓解率以及对原位癌患者的反应持续时间，还包括总生存期。

Results

In total, 255 patients were randomly assigned to arm A and 262 to arm B.

总共，255名患者被随机分配到A组，262名患者被分配到B组。

The trial did not meet its primary endpoint; there was no significant difference in EFS between arms, with a hazard ratioof 0.98 (95% confidence interval0.71-1.36, P = 0.9106).

该试验未达到其主要终点；两组之间的无进展生存期（EFS）没有显著差异，风险比为0.98（95%置信区间0.71-1.36，P = 0.9106）。

EFS results were consistent across all prespecified subgroups.

无进展生存期（EFS）的结果在所有预先指定的亚组中保持一致。

The safety profile of the treatment combination was consistent with that of the individual agents but showed higher rates of treatment-related adverse events (TRAEs) and grade ≥3 TRAEs than BCG alone.

治疗组合的安全性特征与单独使用各药物时一致，但显示出比单独使用BCG更高的治疗相关不良事件(TRAEs)发生率和≥3级TRAEs发生率。

Conclusions

This phase III trial in BCG-naive patients with high-risk NMIBC did not demonstrate an EFS benefit from the addition of atezolizumab to 1-year BCG therapy, in contrast to positive EFS results reported with another PD-(L)1 agent, suggesting that any benefit from checkpoint-BCG therapy may be context- and agent-specific rather than a class effect.

这项针对BCG初治的高危非肌层浸润性膀胱癌患者的III期试验，并未显示出在1年BCG治疗基础上添加阿替利珠单抗对无事件生存(EFS)有获益，与另一PD-(L)1药物报告的积极EFS结果形成对比，这表明从检查点-BCG治疗中获得的任何益处可能是特定于上下文和药物的，而不是一种类别效应。

Future research should focus on biomarker-driven patient selection and optimization of the timing, duration, and route of checkpoint delivery relative to BCG.

未来的研究应集中在基于生物标志物的患者选择以及优化检查点递送的时间、持续时间和途径，相对于BCG而言。