Neoadjuvant nivolumab plus chemotherapy in resectable NSCLC: A pharmacological outcome study
Pakistan Journal of Pharmaceutical Sciences, vol.39, no.8, pp.2535-2545, 2026 (SCI-Expanded, Scopus)
- Publication Type: Article / Article
- Volume: 39 Issue: 8
- Publication Date: 2026
- Doi Number: 10.36721/pjps.2026.39.8.238.1
- Journal Name: Pakistan Journal of Pharmaceutical Sciences
- Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, EMBASE, MEDLINE, Biomedical Reference Collection: Corporate Edition (EBSCO)
- Page Numbers: pp.2535-2545
- Keywords: Common terminology criteria for adverse events (CTCAE v5.0), Immune checkpoint inhibitors, Kirsten rat sarcoma virus on oncogene homologue (KRAS), Major pathological response (MPR), Neoadjuvant chemoimmunotherapy, Nivolumab plus chemotherapy, Pathologic complete response (pCR), Programmed death ligand 1 (PD-L1) expression, Resectable non-small cell lung cancer (NSCLC)
- Open Archive Collection: AVESIS Open Access Collection
- Acibadem Mehmet Ali Aydinlar University Affiliated: Yes
Abstract
Background: Immune checkpoint inhibitors have transformed anticancer pharmacotherapy, with nivolumab demonstrating significant immunomodulatory potential when combined with cytotoxic agents. However, real-world pharmacological evidence regarding the safety, tolerability and biomarker-guided response of neoadjuvant nivolumab combined with platinum-based chemotherapy in resectable non-small cell lung cancer (NSCLC) remains limited. This study aimed to evaluate the pharmacological efficacy, safety profile and predictive biomarker associations of this combination regimen in clinical practice. Methods: A multicenter retrospective pharmacological outcome study was conducted in 58 patients with stage IB–IIIB resectable NSCLC who received four cycles of neoadjuvant nivolumab in combination with platinum-based chemotherapy. The primary pharmacodynamic endpoint was major pathological response (MPR), serving as a surrogate marker of drug efficacy. Secondary endpoints included pathological complete response (pCR), treatment completion rate, post-treatment surgical resectability and incidence of adverse drug reactions graded according to CTCAE v5.0. Programmed death-ligand 1 (PD-L1) expression and KRAS mutation status were evaluated as predictive biomarkers of drug response. Results: The median patient age was 60 years, with male predominance (70.7%). Adenocarcinoma was the most prevalent histological subtype (60.3%). High PD-L1 expression (≥50%) was observed in 31.5% of patients, while KRAS mutations were detected in 44.8%. Curative surgical resection was achieved in 77.6% of patients following neoadjuvant pharmacotherapy. MPR and pCR rates were 43.1% and 29.3%, respectively, with significantly higher response rates observed in patients exhibiting elevated PD-L1 expression. Grade ≥3 adverse drug reactions occurred in 17.2% of patients, with no treatment-related mortality, indicating an acceptable safety and tolerability profile. Conclusion: Neoadjuvant nivolumab combined with platinum-based chemotherapy demonstrates favorable pharmacological efficacy, manageable toxicity and biomarker-driven therapeutic response in resectable NSCLC under real-world clinical conditions. These findings support the role of personalized immunopharmacotherapy and reinforce the clinical relevance of biomarker-guided drug selection in modern pharmaceutical oncology.