Abstract

Background

Clinical trials show favorable OS for patients (pts) with incident aNSCLC and programmed death ligand 1 (PD-L1) expression treated with PD-L1 immune checkpoint inhibitor (ICI) pembrolizumab (PEM) or PEM-chemotherapy compared to no ICI. We use real world data to examine OS in pts with PEM-based regimens vs NoICI as initial aNSCLC treatment by PD-L1 expression.

Methods

This retrospective study used de-identified administrative claims, including month of death (MoD) from regular operations, spanning 1/2017-12/2018 from a large, national US insurer. Claims were linked with biomarker test data from a CLIA-certified cancer diagnostics lab. During 2018, Medicare Advantage pts having ≥1 claim with diagnosis (dx) of lung cancer (ICD-10 C34), advanced disease (C77-C79), a PD-L1 test (CPT 88360) and test result, Tumor Proportion Score (TPS), were included. Pts were newly diagnosed (no C34 in 2017) and continuously enrolled in 2017 & 2018 or until death in 2018. Cohorts were based on initial therapy as PEM-based or NoICI and TPS result. Pts were followed from dx to MoD or 12/2018. OS was MoD, minus month of dx; otherwise censored at 12/2018. Multivariable Cox proportional hazard regressions compared OS across cohorts.

Results

457 pts met study criteria: 126 PEM-based and 331 NoICI. Median age was 76 years in both cohorts. PEM-based had more males (63% vs 51%; p = 0.02) Median months followed was 6 (PEM-based) and 4 (NoICI). For PEM-based , 23 (18%) had TPS 0, 36 (29%) had TPS 1- 49 and 67 (53%) had TPS 50+. For NoICI, 118 (36%) had TPS 0, 120 (36%) had TPS 1- 49, and 93 (28%) had TPS 50+. 20% (n = 25) of PEM-based and 31% (n = 104) of NoICI died during the study period. Mortality hazard ratios for PEM-based vs NoICI by TPS score were: TPS 0, 0.46 (CI 95% 0.16 – 1.30); TPS 1 to 49, 0.73 (CI 95% 0.35 – 1.52); and TPS 50+,0.35 (CI 95% 0.18 – 0.68). OS was more favorable for the PEM-based cohort for all TPS groups, though only TPS 50+ was significant.

Conclusion

This study used administrative claims and lab test data allowing examination of effectiveness of PEM-based vs. NoICI therapy for aNSCLC. As in clinical trials, this analysis suggests OS benefit for PEM-based vs NoICI. Further analysis with longer follow-up will better assess OS benefit by TPS score.

Legal entity responsible for the study

UnitedHealth Group.

Funding

Has not received any funding.

Disclosure

J. Staib: Shareholder / Stockholder / Stock options, Full / Part-time employment: UnitedHealth Group; Shareholder / Stockholder / Stock options: Bristol Myers Squibb; Shareholder / Stockholder / Stock options: Merck; Shareholder / Stockholder / Stock options: Natera; Shareholder / Stockholder / Stock options: NeoGenomics. S. Sudarsanam: Shareholder / Stockholder / Stock options, Full / Part-time employment: NeoGenomics Laboratories. S. Dacosta Byfield: Shareholder / Stockholder / Stock options, Full / Part-time employment: UnitedHealth Group. C. Kennedy: Shareholder / Stockholder / Stock options, Full / Part-time employment: UnitedHealth Group. L. Weiss: Shareholder / Stockholder / Stock options, Full / Part-time employment: NeoGenomics Laboratories.

中文翻译：

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晚期非小细胞肺癌（aNSCLC）中PD-L1表达和总生存期（OS）的76P现实世界数据分析

抽象的

背景

临床试验显示，与未使用ICI相比，使用PD-L1免疫检查点抑制剂（ICI）派姆单抗（PEM）或PEM化疗治疗的aNSCLC事件和程序性死亡配体1（PD-L1）表达患者的OS良好。我们使用现实世界的数据来检查以PEM为基础的治疗方案与NoICI（以PD-L1表达作为初始aNSCLC治疗）的患者的OS。

方法

这项回顾性研究使用了身份不明的行政索赔，包括常规业务的死亡月份（MoD），时间跨度为1 / 2017-12 / 2018，来自一家大型的美国国民保险公司。索赔与来自CLIA认证的癌症诊断实验室的生物标志物测试数据相关联。在2018年期间，Medicare Advantage pts的诊断（dx）为肺癌（ICD-10 C34），晚期疾病（C77-C79），PD-L1测试（CPT 88360）和测试结果，肿瘤比例评分（ TPS）。Pts是新诊断的（2017年没有C34），并在2017和2018年或直到2018年死亡之前持续入组。队列基于基于PEM或NoICI和TPS结果的初始治疗。从dx到MoD或12/2018，追踪点数。OS是MoD，减去dx的月份；否则将在12/2018进行审查。多变量Cox比例风险回归比较了不同人群的OS。

结果

457分符合研究标准：126个基于PEM的研究和331个NoICI。两组的中位年龄均为76岁。基于PEM的男性较多（63％比51％； p = 0.02），随后的中位数为6个月（基于PEM）和4个月（NoICI）。对于基于PEM的产品，TPS 0为23（18％），TPS 1-49为36（29％），TPS 50+为67（53％）。对于NoICI，TPS 0为118（36％），TPS 1-49为120（36％），TPS 50+为93（28％）。在研究期间，有20％（n = 25）的基于PEM的患者和31％（n = 104）的NoICI死亡。基于TPS评分的基于PEM的疾病危险比与NoICI的死亡风险比为：TPS 0，0.46（CI 95％0.16 – 1.30）；TPS 1至49，0.73（CI 95％0.35 – 1.52）；TPS 50 +，0.35（CI 95％0.18 – 0.68）。对于所有TPS组，OS对于基于PEM的队列更为有利，尽管只有TPS 50+才有意义。

结论

这项研究使用了行政声明和实验室测试数据，可以检查基于PEM的药物与NoICI疗法对aNSCLC的有效性。与临床试验一样，该分析表明基于PEM的操作系统与NoICI相比具有OS优势。进行更长时间随访的进一步分析将更好地通过TPS评分评估OS获益。

负责研究的法人实体

联合健康集团。

资金

尚未收到任何资金。

揭露

J. Staib：股东/股东/股票期权，全职/兼职：UnitedHealth Group；股东/股东/股票期权：Bristol Myers Squibb；股东/股东/股票期权：默克；股东/股东/股票期权：Natera；股东/股东/股票期权：NeoGenomics。S. Sudarsanam：股东/股东/股票期权，全职/兼职：NeoGenomics Laboratories。S. Dacosta Byfield：股东/股东/股票期权，全职/兼职：UnitedHealth Group。C.肯尼迪：股东/股东/股票期权，全职/兼职：UnitedHealth Group。L. Weiss：股东/股东/股票期权，全职/兼职：NeoGenomics Laboratories。