LEAP-008: Lenvatinib Plus Pembrolizumab for Metastatic NSCLC That Has Progressed After an Anti-Programmed Cell Death Protein 1 or Anti-Programmed Cell Death Ligand 1 Plus Platinum Chemotherapy.

Methods

Participants were randomized 4:4:1 to once-daily lenvatinib 20 mg plus pembrolizumab 200 mg every 3 weeks (maximum 35 cycles), docetaxel 75 mg/m2 every 3 weeks, or once-daily lenvatinib 24 mg.

参与者按4:4:1的比例随机分配至每日一次的仑伐替尼20 mg联合每3周一次的帕博利珠单抗200 mg（最多35个周期）、每3周一次的多西他赛75 mg/m2，或每日一次的仑伐替尼24 mg。

Primary end points were overall survival(OS) and progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 by central review.

主要终点是根据实体瘤反应评估标准第1.1版通过中央审查的整体生存（OS）和无进展生存（PFS）

The superiority of lenvatinib plus pembrolizumab versus docetaxel was assessed at interim analysis 2 for PFS and final analysis for OS.

在中期分析2评估了仑伐替尼联合派姆单抗与多西他赛相比在无进展生存（PFS）上的优越性，并在最终分析中评估了整体生存（OS）

Results

Participants (N = 422) were randomized to lenvatinib plus pembrolizumab (n = 185), docetaxel (n = 189), or lenvatinib monotherapy (n = 48).

参与者（N = 422）被随机分配到仑伐替尼联合派姆单抗（n = 185），多西他赛（n = 189），或仑伐替尼单药治疗（n = 48）。

The median (95% confidence interval[CI]) PFS was 5.6 (4.2‒6.5) months with lenvatinib plus pembrolizumab and 4.2 (3.2‒5.2) months with docetaxel (hazard ratio, 0.89 [95% CI: 0.70‒1.12]; p = 0.164).

仑伐替尼联合派姆单抗的中位无进展生存期（95%置信区间[CI]）为5.6（4.2‒6.5）个月，多西他赛为4.2（3.2‒5.2）个月（风险比，0.89 [95% CI: 0.70‒1.12]；p = 0.164）。

The median (95% CI) OS was 11.3 (9.4‒13.2) versus 12.0 (9.6‒13.7) months (hazard ratio, 0.98 [95% CI: 0.78‒1.23]; p = 0.434).

中位总生存期（95%置信区间）为11.3个月（9.4‒13.2）对比12.0个月（9.6‒13.7），危险比为0.98（95%置信区间：0.78‒1.23）；p值为0.434。

Rates of treatment-related adverse events were 91.7%, 91.0%, and 89.4% with lenvatinib plus pembrolizumab, docetaxel, and lenvatinib, respectively; the rates of grade 3 to 5 treatment-related adverse events were 59.7%, 48.6%, and 57.4%.

与乐伐替尼联合派姆单抗、多西他赛和乐伐替尼相关的治疗相关不良事件发生率分别为91.7%、91.0%和89.4%；3至5级治疗相关不良事件的发生率分别为59.7%、48.6%和57.4%。

Health-related quality of life scores were similar between treatment arms.

不同治疗组之间的健康相关生活质量评分相似。

Conclusions

Lenvatinib plus pembrolizumab did not improve efficacy versus docetaxel in participants with stage IV NSCLC that progressed on anti‒programmed cell death protein 1 or anti-programmed cell death ligand 1 therapy and platinum-containing chemotherapy.

在对程序性细胞死亡蛋白1或程序性细胞死亡配体1疗法以及含铂化疗药物治疗后进展的IV期非小细胞肺癌患者中，Lenvatinib联合Pembrolizumab并未显示出比多西他赛更好的疗效。

There were no unexpected safety signals.

未出现意外的安全信号。

More effective therapies are needed for this patient population.

这一患者群体需要更有效的治疗方法。