1. Efficacy of Pembrolizumab vs. Nivolumab Plus Ipilimumab in Metastatic NSCLC in Relation to PD-L1 and TMB Status.
- Author
-
Shalata, Walid, Maimon Rabinovich, Natalie, Agbarya, Abed, Yakobson, Alexander, Dudnik, Yulia, Abu Jama, Ashraf, Cohen, Ahron Yehonatan, Shalata, Sondos, Abu Hamed, Ahmad, Ilan Ber, Tahel, Machluf, Oshri, Shoham Levin, Gal, and Meirovitz, Amichay
- Subjects
- *
THERAPEUTIC use of monoclonal antibodies , *PROGRAMMED death-ligand 1 , *TREATMENT effectiveness , *CANCER patients , *METASTASIS , *KAPLAN-Meier estimator , *RESEARCH , *NIVOLUMAB , *LUNG cancer , *GENETIC mutation , *PROPORTIONAL hazards models - Abstract
Simple Summary: This study focused on immune checkpoint inhibitor therapy effectiveness in patients with non-small cell lung cancer (NSCLC), particularly concerning programmed death ligand 1 (PD-L1) status and tumor mutational burden (TMB). The study utilized an Israeli multi-center registry spanning from January 2018 to December 2022, compiling detailed clinicopathological and molecular epidemiological data alongside treatment modalities. Clinical endpoints were assessed through Kaplan–Meier curves and Cox-regression models based on treatment assignment. While evidence on PD-L1 status and immune checkpoint inhibitors is established, data on TMB efficacy in both clinical trials and real-world settings are lacking. This study presents the largest academic real-world dataset on PD-L1 and TMB status in advanced NSCLC patients, suggesting comparable survival benefits despite limited direct comparisons. The efficacy of immune checkpoint inhibitor (ICI) therapy concerning programmed death ligand 1 (PD-L1) status is well established in patients diagnosed with non-small cell lung cancer (NSCLC). However, there remains a paucity of evidence regarding the efficacy concerning tumor mutational burden (TMB) in both clinical trials and real-world data (RWD). In the current article, clinicopathological and molecular epidemiological data were meticulously collected, and treatment modalities were meticulously recorded. The final analysis included a study population of 194 patients. Median age was 67 years (range 37–86), with the majority being male (71.13%), and 85.71% of patients were either current or former smokers at diagnosis. Adenocarcinoma accounted for most diagnoses (71.65%), followed by squamous cell carcinoma (24.23%). In terms of PD-L1 status, 42.78% had an expression level below 1%, 28.35% had an expression between 1–49%, and 28.87% had an expression above 50%. The TMB ranged from 0 to 75, with a median of 10.31 (range 0–75) for PD-L1 expression below 1%, with a median of 9.73 (range 0.95–39.63) for PD-L1 expression between 1–49%, and a median of 9.72 (range 0.95–48) for PD-L1 expression above 50%. Corresponding to patients with low PDL-1 less than 1% and low TMB (0–5), the median overall survival (mOS) was 16 (p = 0.18), and 15 months (p = 0.22), patients with medium PDL-1 (1–49%) and medium TMB (5–10), the mOS was 15 (p = 0.18) and 16 months (p = 0.22), patients with high PDL-1 (>50) and high TMB (>10), the mOS was 24 (p = 0.18) and 21 (p = 0.22) months. This study represents the largest academic RWD dataset concerning PD-L1 and TMB status in patients with locally advanced and metastatic NSCLC. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF