Real-world data from the Portuguese Nivolumab Expanded Access Program (EAP) in previously treated Non Small Cell Lung...

Area of Science:

• Oncology
• Immunotherapy
• Clinical Research

Background:

• Advanced Non-Small Cell Lung Cancer (NSCLC) presents treatment challenges.
• Immune-checkpoint inhibitors offer a novel therapeutic approach.
• Real-world data is crucial for understanding treatment outcomes.

Purpose of the Study:

• To evaluate the efficacy and safety of Nivolumab in advanced, previously treated NSCLC patients.
• To assess real-world effectiveness of Nivolumab in a Portuguese patient cohort.
• To analyze Overall Response Rate (ORR), Disease Control Rate (DCR), Progression Free Survival (PFS), and Overall Survival (OS).

Main Methods:

• Retrospective, multicentre data analysis of the Portuguese Nivolumab Expanded Access Program (EAP).
• Inclusion criteria: histologically confirmed NSCLC, stage IIIB/IV, prior chemotherapy.
• Tumor response assessed by RECIST v1.1; safety by CTCAE v4.0.

Main Results:

• 229 advanced NSCLC patients enrolled; data available for 219.
• ORR was 22.4%, DCR was 53.4%.
• Median PFS was 4.91 months; median OS was 13.21 months. Safety profile consistent with clinical trials.

Conclusions:

• Nivolumab efficacy and safety in this real-world NSCLC cohort align with clinical trial findings.
• The study supports the use of Nivolumab in previously treated advanced NSCLC.
• Real-world data confirms the value of immune-checkpoint inhibitors in NSCLC management.