Avelumab plus sacituzumab govitecan versus avelumab monotherapy as first-line maintenance treatment in patients with advanced urothelial carcinoma: JAVELIN Bladder Medley interim analysis.

The JAVELIN Bladder Medley phase II trial is investigating the efficacy and safety of maintenance treatment with avelumab combined with other antitumor agents versus avelumab monotherapy.

JAVELIN Bladder Medley II期试验正在研究avelumab联合其他抗肿瘤药物与avelumab单药维持治疗的有效性和安全性。

We report an interim analysis of avelumab plus sacituzumab govitecan (SG) versus avelumab monotherapy.

我们报告了avelumab联合sacituzumab govitecan (SG)与avelumab单药治疗的中期分析结果。

patients_and_methods

Patients with la/mUC without progression after first-line PBC were randomized 2 : 1 to receive avelumab (800 mg every 2 weeks) plus SG (10 mg/kg on days 1 and 8 of 21-day cycles) or avelumab monotherapy (800 mg every 2 weeks).

在一线PBC治疗后未出现进展的局部晚期/转移性尿路上皮癌患者按照2:1的比例随机接受avelumab（每两周800 mg）联合SG（每21天周期的第1天和第8天给予10 mg/kg）治疗或avelumab单药治疗（每两周800 mg）。

Primary endpoints are investigator-assessed progression-free survival(PFS) and safety.

主要终点是研究者评估的无进展生存期（PFS）和安全性。

For PFS and overall survival(OS), data in the avelumab monotherapy arm were extended per protocol using propensity score-weighted JAVELIN Bladder 100 data.

对于无进展生存期（PFS）和总生存期（OS），根据协议使用倾向评分加权的JAVELIN Bladder 100数据对avelumab单药治疗组的数据进行了延长。

Results

At data cut-off (16 September 2024), 38/74 patients (51.4%) in the avelumab plus SG arm and 10/37 patients (27.0%) in the avelumab monotherapy arm were still receiving study treatment.

在数据截止日期（2024年9月16日），avelumab加SG组的38/74名患者（51.4%）和avelumab单药治疗组的10/37名患者（27.0%）仍在接受研究治疗。

Median PFS with avelumab plus SG versus avelumab monotherapy was 11.17 versus 3.75 months, respectively [hazard ratio(HR) 0.49, 95% confidence interval(CI) 0.31-0.76; prespecified efficacy boundary: HR ≤ 0.60].

avelumab加SG与avelumab单药治疗的中位无进展生存期（PFS）分别为11.17个月和3.75个月[风险比（HR）0.49，95%置信区间（CI）0.31-0.76；预设的疗效界限：HR ≤ 0.60]。

OS data were immature; median OS was not reached versus 23.75 months, respectively (HR 0.79, 95% CI 0.42-1.50).

总生存数据尚未成熟；中位总生存期未达到与23.75个月（风险比0.79，95%置信区间0.42-1.50）。

In patients treated with avelumab plus SG or avelumab monotherapy, any-grade treatment-related adverse events (TRAEs) occurred in 97.3% versus 63.9% (grade ≥3 in 69.9% versus 0%), respectively.

在接受avelumab联合SG治疗或avelumab单药治疗的患者中，任何级别的治疗相关不良事件（TRAEs）发生率分别为97.3%与63.9%（3级及以上不良事件发生率为69.9%与0%）。

Conclusions

In patients with la/mUC without progression after first-line PBC, PFS was prolonged with avelumab plus SG versus avelumab monotherapy as maintenance treatment.

在一线PBC治疗后无进展的局部晚期/转移性尿路上皮癌患者中，avelumab联合SG作为维持治疗相比avelumab单药治疗，无进展生存期得到了延长。

TRAEs were more frequent with the combination and were consistent with known safety profiles of SG and avelumab.

联合治疗组的治疗相关不良事件（TRAEs）更为频繁，与SG和avelumab已知的安全性档案一致。

Combining avelumab with anti-Trop-2 antibody-drug conjugates may be a promising strategy to improve patient outcomes in la/mUC.

将阿维鲁单抗与抗Trop-2抗体药物偶联物联合使用，可能是改善la/mUC患者预后的有希望的策略。