FDA Approval Summary: Durvalumab for the Treatment of Adult Patients with Muscle-Invasive Bladder Cancer.

Food and Drug Administration (FDA) approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment following radical cystectomy (RC), for adults with muscle-invasive bladder cancer (MIBC).

美国食品药品监督管理局（FDA）批准了durvalumab（Imfinzi, 阿斯利康）联合吉西他滨和顺铂作为新辅助治疗，随后在根治性膀胱切除术（RC）后使用单药durvalumab作为辅助治疗，用于治疗成人肌层浸润性膀胱癌（MIBC）。

Substantial evidence of effectiveness was obtained from NIAGARA (NCT03732677), a randomized, phase III, open-label trial in cisplatin-eligible patients with MIBC who had not received prior systemic chemotherapy or immunotherapy.

从NIAGARA (NCT03732677)中获得了显著的有效性证据，这是一项随机、III期、开放标签试验，针对未接受过全身化疗或免疫治疗的顺铂合格的局部晚期膀胱癌患者。

A total of 1,063 patients were randomized (1:1) to receive neoadjuvant durvalumab + gemcitabine and cisplatin prior to RC, followed by adjuvant durvalumab (GC-D), or neoadjuvant gemcitabine and cisplatin (GC) prior to RC, with no subsequent adjuvant treatment.

共有1,063名患者被随机分配（1:1），一组接受新辅助durvalumab + 吉西他滨和顺铂治疗，随后进行根治性膀胱切除术（RC），术后接受辅助durvalumab治疗（GC-D），另一组接受新辅助吉西他滨和顺铂治疗（GC），术后再无辅助治疗。

The dual primary endpoints were event-free survival (EFS) and pathologic complete response (pCR), both per blinded independent central review.

主要的双重主要终点是无事件生存（EFS）和病理完全缓解（pCR），均按照盲法独立中央审查进行评估。

The key secondary endpoint (α-controlled) was overall survival(OS).

关键的次要终点（α控制）是总生存（OS）。

GC-D demonstrated a statistically significant improvement in EFS compared with GC at the second interim analysis, with a hazard ratio(HR) of 0.68 [95% confidence interval(CI), 0.56-0.82; P < 0.0001].

GC-D 在第二次中期分析中显示出与 GC 相比在无进展生存期（EFS）上有统计学显著性改善，风险比（HR）为0.68 [95% 置信区间（CI），0.56-0.82; P < 0.0001]。

The median EFS was not reached (NR) for GC-D and was estimated to be 46.1 months (95% CI, 32.3-NR) for GC.

GC-D 的中位无进展生存期未达到（NR），而 GC 的中位无进展生存期估计为46.1个月（95% CI, 32.3-NR）。

There was no statistically significant difference in the pCR rate between the arms.

两组之间的病理完全缓解（pCR）率没有统计学上的显著差异。

A statistically significant improvement in OS was observed for GC-D compared with G + C, with an HR of 0.75 (95% CI, 0.59-0.93; two-sided P = 0.0106).

与G+C相比，GC-D的总生存（OS）有统计学上的显著改善，风险比（HR）为0.75（95%置信区间，0.59-0.93；双侧P值=0.0106）。

The median OS was NR in both arms.

两组的中位总生存期均为未达到。

Safety seemed consistent with the safety profile demonstrated in prior trials of durvalumab in combination with platinum-based chemotherapy.

安全性似乎与之前durvalumab联合铂类化疗的试验中所展示的安全性特征一致。