INDUCE-3: A Randomized Phase II/III Study of First-line Feladilimab plus Pembrolizumab in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.

patients_and_methods

INDUCE-3 (NCT04128696) was a randomized, double-blind, phase II/III study in patients with first-line PD-L1-positive recurrent and/or metastatic HNSCC.

INDUCE-3 (NCT04128696)是一项随机、双盲、II/III期研究，针对一线PD-L1阳性复发和/或转移性头颈部鳞状细胞癌(HNSCC)患者。

A 2-in-1 adaptive design was implemented, with an option to expand the phase II study into a phase III confirmatory study.

实施了一种2合1的自适应设计，可以选择将II期研究扩展为III期确认性研究。

Patients were randomized 1:1 to receive feladilimab plus pembrolizumab or placebo plus pembrolizumab, with up to 35 cycles of treatment for approximately 2 years.

患者按1:1的比例随机接受feladilimab联合pembrolizumab治疗或安慰剂联合pembrolizumab治疗，治疗周期最多35个周期，大约持续2年。

Primary endpoints were overall survival(OS) and investigator-assessed progression-free survival(PFS).

主要终点是总生存（OS）和研究者评估的无进展生存（PFS）。

Results

The study enrolled 315 patients.

该研究招募了315名患者。

Following the review of unblinded interim data in 140 patients, an Independent Data Monitoring Committee recommended stopping patient accrual based on prespecified criteria.

在审查了140名患者的未盲中期数据后，独立数据监测委员会根据预先设定的标准建议停止患者入组。

Existing patients discontinued feladilimab or placebo.

现有的患者停止了feladilimab或安慰剂的使用。

Pembrolizumab treatment continued until prespecified stopping criteria were met.

直至达到预设的停止标准，继续进行帕博利珠单抗治疗。

This study demonstrated no evidence of an effect in favor of feladilimab plus pembrolizumab, with an adjusted HR of 1.51 for OS and 1.40 for PFS (median OS: 44.1 weeks [95% confidence interval(CI), 35.9-not applicable]; median PFS: 10.1 weeks [95% CI, 9.1-15]) versus placebo plus pembrolizumab [median OS: not reached; median PFS: 16 weeks (95% CI, 14.3-26.1)].

该研究未显示出feladilimab联合帕博利珠单抗相比安慰剂联合帕博利珠单抗有任何优势，总生存期（OS）的调整后风险比（HR）为1.51，无进展生存期（PFS）的HR为1.40（中位OS：44.1周[95%置信区间（CI），35.9-不适用]；中位PFS：10.1周[95% CI, 9.1-15]）与安慰剂联合帕博利珠单抗相比[中位OS未达到；中位PFS：16周（95% CI, 14.3-26.1）]。

The incidenceof treatment-related adverse events was higher in the placebo group.

治疗相关不良事件的发生率在安慰剂组中更高。

Conclusions

This analysis does not support the combination of feladilimab plus pembrolizumab due to a lack of superiority over placebo plus pembrolizumab.

由于与安慰剂加派姆单抗相比缺乏优越性，本分析不支持联合使用费拉地单抗加派姆单抗。