Abstract
Introduction: Prevention, early diagnosis and treatment of oncological diseases remain a significant challenge for modern medicine. The discovery of immune checkpoint inhibitors, including programmed death protein and programmed death ligand 1 (PD-1/PD-L1), has made a significant breakthrough in modern approaches to the treatment of oncological diseases. These monoclonal antibodies block the “braking” mechanisms of the immune system, which allows T-lymphocytes to recognize and destroy tumor cells.
This research paper aims to analyze the characteristics of PD-L1 expression in a cohort of 108 patients with non-small cell lung cancer (NSCLC) in Georgia;
Methods: An observational and quantitative study was conducted, which included 108 patients with NSCLC registered in 2025 at the “Todua” and “Healthycore” clinics in Georgia. Clinical data were obtained from laboratory records and electronic medical databases. PD-L1 expression was assessed using standard clinical protocols. Patients were categorized according to the level of expression: <1%, 1–49% and ≥50%. The data were processed retrospectively, using descriptive statistics. The use of this methodology ensures the reliability, reproducibility and generalizability of the study results to the Georgian population in a national context.
Results: The analysis showed that only 18.5% of the studied cohort had high PD-L1 expression (TPS, CPS ≥ 50%), which makes them optimal candidates for first-line monotherapy. The majority of the population (76.8%) had low or negative expression, indicating that monotherapy alone is insufficient for adequate clinical response in these patients. The study showed a low test-miss rate (4.6%). In addition, it was noted that atezolizumab, despite funding from government programs, is rarely used compared to other drugs in NSCLC due to its low clinical efficacy.
Conclusion: Although the discovery of PD-1/PD-L1 inhibitors has revolutionized oncology, their efficacy is not universal and requires a personalized, multidisciplinary approach. The “biomarker dilemma” remains a subject of research, as high PD-L1 expression does not always provide an absolute guarantee of success. Some patients with negative expression levels still receive positive therapeutic benefits. Patients with low expression for most, multimodal strategies, such as combining immunotherapy with chemotherapy or targeted therapy, are necessary to transform “cold” tumors into “hot,” immunoactive forms. Further development of anti-PD-1/PD-L1 immunotherapy is fully based on personalized medicine – targeted treatment tailored to the individual patient. Further refinement of personalized treatment models requires future large-scale, prospective clinical trials in the Georgian population.
References
[1] Bartusik-Aebisher, D., Rogóż, K., & Aebisher, D. (2025). STING-Activating Nanoparticles Combined with PD-1/PD-L1 Blockade: A Synergistic Approach in Cancer Immunotherapy. Biomedicines, 13(9), 2160. https://doi.org/10.3390/biomedicines13092160
[2] Han, Y., Liu, D., & Li, L. (2020). PD-1/PD-L1 pathway: current researches in cancer. American journal of cancer research, 10(3), 727–742.
[3] Mandal, K., Barik, G. K., & Santra, M. K. (2025). Overcoming resistance to anti-PD-L1 immunotherapy: mechanisms, combination strategies, and future directions. Molecular cancer, 24(1), 246. https://doi.org/10.1186/s12943-025-02400-z
[4] Rieth, J., & Subramanian, S. (2018). Mechanisms of Intrinsic Tumor Resistance to Immunotherapy. International journal of molecular sciences, 19(5), 1340. https://doi.org/10.3390/ijms19051340
[5] Wojas-Krawczyk, K., Kalinka, E., Grenda, A., Krawczyk, P., & Milanowski, J. (2019). Beyond PD-L1 Markers for Lung Cancer Immunotherapy. International journal of molecular sciences, 20(8), 1915. https://doi.org/10.3390/ijms20081915
[6] Xu, Y., Shen, H., Shang, D., & Zhu, C. (2026). Pharmacological strategies to overcome immune checkpoint inhibitor resistance in non-small cell lung cancer. Frontiers in oncology, 15, 1665239. https://doi.org/10.3389/fonc.2025.1665239
