Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer.

Methods

In this phase 3, open-label, international trial, we randomly assigned patients in a 1:1 ratio to receive sacituzumab govitecan plus pembrolizumab or chemotherapy plus pembrolizumab.

在这项III期、开放标签、国际试验中，我们以1:1的比例随机分配患者接受sacituzumab govitecan联合pembrolizumab治疗或化疗联合pembrolizumab治疗。

The primary end point was progression-free survivalas assessed by blinded independent central review.

主要终点是通过盲法独立中央审查评估的无进展生存期。

Secondary end points included overall survival, objective response (complete or partial response) and duration of response as assessed by blinded independent central review, and safety.

次要终点包括通过盲法独立中央审查评估的总生存期、客观缓解率（完全或部分缓解）及缓解持续时间，以及安全性。

Results

A total of 443 patients were randomly assigned to receive sacituzumab govitecan plus pembrolizumab (221 patients) or chemotherapy plus pembrolizumab (222 patients).

共有443名患者被随机分配接受sacituzumab govitecan联合pembrolizumab治疗（221名患者）或化疗联合pembrolizumab治疗（222名患者）。

The median progression-free survivalwas 11.2 months (95% confidence interval[CI], 9.3 to 16.7) with sacituzumab govitecan plus pembrolizumab and 7.8 months (95% CI, 7.3 to 9.3) with chemotherapy plus pembrolizumab (hazard ratiofor disease progression or death, 0.65; 95% CI, 0.51 to 0.84; two-sided P<0.001).

sacituzumab govitecan联合pembrolizumab治疗的中位无进展生存期为11.2个月（95%置信区间[CI]，9.3至16.7个月），而化疗联合pembrolizumab治疗的中位无进展生存期为7.8个月（95% CI，7.3至9.3个月）（疾病进展或死亡的风险比为0.65；95% CI，0.51至0.84；双侧P<0.001）。

Data for overall survivalwere immature.

总生存数据尚不成熟。

The percentage of patients with an objective response was 60% (95% CI, 53 to 66) with sacituzumab govitecan plus pembrolizumab and 53% (95% CI, 46 to 60) with chemotherapy plus pembrolizumab; among patients with a response, the median duration of response was 16.5 months (95% CI, 12.7 to 19.5) and 9.2 months (95% CI, 7.6 to 11.3), respectively.

接受sacituzumab govitecan联合pembrolizumab治疗的患者中，客观缓解率为60%（95%置信区间，53至66），而接受化疗联合pembrolizumab治疗的患者中，客观缓解率为53%（95%置信区间，46至60）；在有反应的患者中，缓解持续时间的中位数分别为16.5个月（95%置信区间，12.7至19.5）和9.2个月（95%置信区间，7.6至11.3）。

Adverse events of grade 3 or higher occurred in 71% of the patients receiving sacituzumab govitecan plus pembrolizumab and in 70% of those receiving chemotherapy plus pembrolizumab; the incidenceof treatment discontinuation due to adverse events was 12% and 31%, respectively.

71%的接受sacituzumab govitecan联合pembrolizumab治疗的患者和70%接受化疗联合pembrolizumab治疗的患者出现了3级或更高级别的不良事件；因不良事件导致治疗中断的发生率分别为12%和31%。

Adverse events leading to death occurred in 3% of the patients in each group.

每组中有3%的患者出现了导致死亡的不良事件。

Conclusions

Sacituzumab govitecan plus pembrolizumab led to significantly longer progression-free survivalthan chemotherapy plus pembrolizumab among patients with previously untreated, PD-L1-positive, advanced triple-negative breast cancer.

在之前未接受治疗、PD-L1阳性、晚期三阴性乳腺癌患者中，Sacituzumab govitecan联合pembrolizumab相较于化疗联合pembrolizumab显著延长了无进展生存期。

(Funded by Gilead Sciences; ASCENT-04/KEYNOTE-D19 ClinicalTrials.gov number, NCT05382286.).

该研究由Gilead Sciences资助；ASCENT-04/KEYNOTE-D19临床试验注册号为NCT05382286。