Survival outcomes in POD1UM-303/InterAACT-2: a phase III study of retifanlimab plus carboplatin-paclitaxel in first-line advanced squamous anal cancer.

In this article, the final overall survival(OS) data from PODIUM-303/InterAACT 2, along with subgroup and exploratory analyses, are presented.

本文呈现了PODIUM-303/InterAACT 2试验的最终总生存（OS）数据，以及亚组和探索性分析结果。

patients_and_methods

POD1UM-303/InterAACT-2 was a phase III, randomized, double-blind, controlled, multicenter trial with an optional crossover period undertaken in Europe, Australia, Japan, the UK, and the United States.

POD1UM-303/InterAACT-2 是一项在欧洲、澳大利亚、日本、英国和美国进行的 III 期、随机、双盲、对照、多中心试验，包含可选的交叉期。

The primary endpoint was PFS, and OS was the key secondary endpoint.

主要终点是无进展生存期（PFS），总生存期（OS）是关键次要终点。

Other endpoints included response, safety, and exploratory subgroup analyses.

其他终点包括反应、安全性和探索性亚组分析。

Results

A total of 308 patients were randomly assigned (n = 154 for each of the retifanlimab plus carboplatin-paclitaxel and placebo plus carboplatin-paclitaxel groups), and 77 patients in the placebo plus carboplatin-paclitaxel group crossed over to receive retifanlimab monotherapy.

共有308名患者被随机分配（retifanlimab加卡铂-紫杉醇组和安慰剂加卡铂-紫杉醇组各有154名患者），并且有77名患者在安慰剂加卡铂-紫杉醇组中交叉接受retifanlimab单药治疗。

When retifanlimab plus carboplatin-paclitaxel was compared with placebo plus carboplatin-paclitaxel in the updated efficacy analysis, there was a continued PFS benefit [hazard ratio(HR) 0.62, 95% confidence interval(CI) 0.47-0.81, nominal P = 0.0002] and a consistent and clinically meaningful improvement in OS (HR 0.75, 95% CI 0.55-1.01, P = 0.0305); median OS was 32.8 versus 22.2 months.

在更新的疗效分析中，当retifanlimab联合卡铂-紫杉醇与安慰剂联合卡铂-紫杉醇进行比较时，持续显示出无进展生存期（PFS）的益处[风险比（HR）0.62，95%置信区间（CI）0.47-0.81，名义P = 0.0002]，并且在总生存（OS）上显示出一致且具有临床意义的改善（HR 0.75，95% CI 0.55-1.01，P = 0.0305）；中位总生存期为32.8个月对比22.2个月。

Overall response rate was 56.5% versus 44.8%, and disease control rates were 87.7% versus 80.5%.

总体缓解率为56.5%对比44.8%，疾病控制率为87.7%对比80.5%。

The results of the crossover-adjusted analysis were consistent with the main analysis, and there was a consistent OS benefit in favor of retifanlimab plus carboplatin-paclitaxel in all subgroups analyzed.

交叉调整后的分析结果与主要分析结果一致，在所有分析的亚组中，retifanlimab联合卡铂-紫杉醇治疗组的总生存期（OS）均显示出一致的获益。

No new safety signals or trends were reported.

未报告新的安全信号或趋势。

Conclusions

This final analysis confirms the benefits of retifanlimab plus chemotherapy in SCAC.

这项最终分析确认了retifanlimab联合化疗在鳞状细胞肛门癌（SCAC）中的益处。

The results suggest that retifanlimab represents a new reference treatment and standard of care for patients with inoperable, locally recurrent, or metastatic SCAC.

结果表明，retifanlimab代表了一种新的参考治疗和不可手术、局部复发或转移性鳞状细胞肛门癌（SCAC）患者的护理标准。