Atezolizumab With Bevacizumab and Nonplatinum Chemotherapy for Recurrent Ovarian Cancer: Final Results From the Placebo-Controlled AGO-OVAR 2.29/ENGOT-ov34 Phase III Trial.

Methods

The double-blindrandomized phase III AGO-OVAR 2.29/ENGOT-ov34 trial (ClinicalTrials.gov identifier: NCT03353831) enrolled patients with first or second relapse of ovarian cancer ≤6 months after completing platinum-based chemotherapy (or third relapse regardless of treatment-free interval).

双盲随机III期AGO-OVAR 2.29/ENGOT-ov34试验（ClinicalTrials.gov注册号：NCT03353831）招募了在完成铂类化疗后6个月内首次或第二次复发的卵巢癌患者，或无论治疗间隔的第三次复发患者。

PD-L1 status was tested centrally (VENTANA SP142 assay) in recent (<3 months) biopsies before random assignment.

PD-L1状态在随机分配前的近期（<3个月）活检中通过VENTANA SP142检测法进行中央检测。

All patients received bevacizumab and investigator-selected chemotherapy (once weekly paclitaxel or pegylated liposomal doxorubicin) until disease progression or toxicity, plus either atezolizumab 840 mg or placebo once every 2 weeks until progression (maximum 2 years), randomly assigned 1:1, and stratified by number of previous lines, planned chemotherapy, previous bevacizumab, and PD-L1 status.

所有患者接受贝伐单抗和研究者选择的化疗（每周一次的紫杉醇或聚乙二醇脂质体多柔比星）直至疾病进展或出现毒性，同时接受阿替利珠单抗840 mg或安慰剂每两周一次直至进展（最多2年），随机分配比例为1:1，并根据既往治疗线数、计划的化疗方案、既往使用贝伐单抗情况以及PD-L1状态进行分层。

Primary end points were overall survival(OS) and progression-free survival(PFS) in the intention-to-treatpopulation.

主要终点是意向治疗人群中的总生存（OS）和无进展生存（PFS）

Results

Among 574 patients randomly assigned between September 2018 and July 2022, 72% were bevacizumab-pretreated, 36% had received three previous treatment lines, 26% had PD-L1-positive tumors, and 54% received paclitaxel with study therapy.

在2018年9月至2022年7月之间随机分配的574名患者中，72%接受过贝伐珠单抗治疗，36%接受过三种之前的治疗方案，26%的肿瘤PD-L1阳性，54%的患者在研究治疗中接受了紫杉醇治疗。

After 418 patients had died, the hazard ratiofor OS was 0.83 (95% CI, 0.68 to 1.01; P = .06; median 14.2 months with atezolizumab and 13.0 months with placebo) and the hazard ratiofor PFS was 0.87 (95% CI, 0.73 to 1.04; P = .12; median 6.4 v 6.7 months, respectively).

在418名患者死亡后，总生存期的危险比为0.83（95%置信区间，0.68至1.01；P=0.06；atezolizumab组中位生存期为14.2个月，安慰剂组为13.0个月），无进展生存期的危险比为0.87（95%置信区间，0.73至1.04；P=0.12；分别中位生存期为6.4个月和6.7个月）。

OS hazard ratios were similar regardless of PD-L1 status.

无论PD-L1状态如何，总生存期的危险比相似。

Grade ≥3 adverse events occurred in 72% of atezolizumab-treated and 69% of placebo patients.

在接受阿替利珠单抗治疗的患者中，72%出现了3级或更高级别的不良事件，在安慰剂组患者中这一比例为69%。

Conclusions

Combining atezolizumab with bevacizumab and chemotherapy did not significantly improve OS or PFS in patients with recurrent ovarian cancer ineligible for platinum.

将阿替利珠单抗与贝伐珠单抗和化疗联合使用，并未显著改善铂类治疗不耐受的复发性卵巢癌患者的总生存期或无进展生存期。

The safety profile was as expected from previous experience with these drugs.

这些药物的安全性特征与以往经验相符。