FDA Approval Summary: Retifanlimab for the Treatment of Adult Patients with Metastatic or Inoperable Locally Recurrent Squamous Cell Carcinoma of the Anal Canal.

These approvals were based on the POD1UM-303 and POD1UM-202 trials.

这些批准是基于POD1UM-303和POD1UM-202两项试验。

In POD1UM-303, 308 patients with no prior systemic treatment for advanced disease were randomized 1:1 to receive retifanlimab or placebo, both combined with carboplatin and paclitaxel.

在POD1UM-303试验中，308名未接受过系统治疗的晚期疾病患者被随机分为1:1，接受Retifanlimab或安慰剂，两者均与卡铂和紫杉醇联合使用。

The primary efficacy outcome was progression-free survival(PFS) assessed by blinded independent central review, with overall survival(OS) as a key secondary endpoint.

主要疗效结果是通过盲法独立中心审查评估的无进展生存期（PFS），总生存期（OS）作为关键次要终点。

The trial demonstrated a statistically significant PFS improvement with a hazard ratio(HR) of 0.63 [95% confidence interval(CI), 0.47-0.84, P value 0.0006].

试验显示了具有统计学意义的PFS改善，风险比（HR）为0.63 [95%置信区间（CI），0.47-0.84，P值0.0006]。

Median PFS was 9.3 months (95% CI, 7.5-11.3) and 7.4 months (95% CI, 7.1-7.7) in the retifanlimab and placebo arms, respectively.

在Retifanlimab组和安慰剂组中，中位PFS分别为9.3个月（95% CI，7.5-11.3）和7.4个月（95% CI，7.1-7.7）。

Interim OS results were not statistically significant [HR, 0.70 (95% CI, 0.49-1.01)] although the point estimate for OS was 29.2 months (95% CI, 24.2-NE) in the retifanlimab arm and 23 months (95% CI, 15.1-27.9) for placebo.

中期OS结果在统计学上不显著[HR，0.70（95% CI，0.49-1.01）]，尽管Retifanlimab组的OS点估计值为29.2个月（95% CI，24.2-NE），而安慰剂组为23个月（95% CI，15.1-27.9）。

Second-line approval was based on POD1UM-202, a single-arm trial of 94 patients receiving single-agent retifanlimab.

二线批准是基于POD1UM-202，一项接受单药Retifanlimab的94名患者的单臂试验。

The independent centrally assessed overall response rate was 14% (95% CI, 8-23).

独立的中央评估的整体反应率为14%（95%置信区间，8-23）。

No new adverse safety signals were identified.

未发现新的不良安全信号。

The approval of retifanlimab as a single agent or in combination with chemotherapy provides a new therapeutic option for patients with unresectable or metastatic SCAC.

retifanlimab作为单药或与化疗联合使用的批准，为无法切除或转移性SCAC患者提供了新的治疗选择。