Real-World Effectiveness of Immune Checkpoint Inhibitors Chemotherapy (ICI+CT) vs. ICI Monotherapy (ICI) in Untreated Locally Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): A Targeted Literature Review
Author(s)
Mariana Farraia, PhD1, Eugenia Priedane, MA2, Silvy Mardiguian, PhD2, Mesha Austin Taylor, PhD3, Caroline von Wilamowitz-Moellendorff, PhD4.
1Evidera, a business unit of PPD, part of Thermo Fisher Scientific, Ede, Netherlands, 2BeOne Medicines, Ltd, London, United Kingdom, 3BeOne Medicines, Ltd, Emeryville, CA, USA, 4Evidera, a business unit of PPD, part of Thermo Fisher Scientific, London, United Kingdom.
1Evidera, a business unit of PPD, part of Thermo Fisher Scientific, Ede, Netherlands, 2BeOne Medicines, Ltd, London, United Kingdom, 3BeOne Medicines, Ltd, Emeryville, CA, USA, 4Evidera, a business unit of PPD, part of Thermo Fisher Scientific, London, United Kingdom.
OBJECTIVES: In Europe, ICIs are commonly recommended for untreated locally advanced/metastatic NSCLC with ≥50% programmed death-ligand 1 (PD-L1) expression, based on randomized controlled trials (RCTs). However, real-world evidence (RWE) suggests some patients benefit more from ICI+CT. We aimed to (1) compare ICI+CT versus ICI outcomes in RWE, (2) identify patient subgroups who may benefit from ICI+CT or ICI, and (3) compare RWE outcomes with RCTs.
METHODS: A protocol-driven targeted literature review was conducted in August 2024 to identify RWE on overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and adverse events (AEs). Searches in Embase and MEDLINE were conducted, and relevant abstracts were screened by a reviewer. Articles were selected according to their suitability to answer the research questions. Relevant RCTs were identified from a separate systematic literature review.
RESULTS: After screening 193 abstracts, 17 RWE studies were included. Clinical outcomes generally favoured ICI+CT over ICI (median OS range, 15-33.7 months versus 13-19.8 months, respectively; median PFS, 7-12.4 months versus 4.4-11.3 months; ORR, 59.8%-68.7% versus 30.3%-47.1%). ICI+CT was associated with more grade ≥3 AEs versus ICI (31.3% versus 26.8%). Subgroups trending towards ICI+CT benefit included women, patients with PD-L1 ≥50% (versus PD-L1 ≥90%), and ECOG performance status 0-1. Subgroups trending towards an ICI benefit included men, and patients with liver or brain metastases. OS, PFS, and ORR were similar in RWE and RCTs for ICI+CT, but for ICI alone, OS, PFS, ORR, and grade ≥3 AEs were generally higher in RCTs than in RWE.
CONCLUSIONS: OS and PFS generally favoured ICI+CT in the identified RWE studies. However, more research is needed to confirm patient subgroups benefiting from ICI+CT or ICI alone. Reported outcomes appear favourable for patients receiving ICI in RCTs than in RWE studies; this discrepancy needs to be understood so that clinicians can make informed treatment decisions.
METHODS: A protocol-driven targeted literature review was conducted in August 2024 to identify RWE on overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and adverse events (AEs). Searches in Embase and MEDLINE were conducted, and relevant abstracts were screened by a reviewer. Articles were selected according to their suitability to answer the research questions. Relevant RCTs were identified from a separate systematic literature review.
RESULTS: After screening 193 abstracts, 17 RWE studies were included. Clinical outcomes generally favoured ICI+CT over ICI (median OS range, 15-33.7 months versus 13-19.8 months, respectively; median PFS, 7-12.4 months versus 4.4-11.3 months; ORR, 59.8%-68.7% versus 30.3%-47.1%). ICI+CT was associated with more grade ≥3 AEs versus ICI (31.3% versus 26.8%). Subgroups trending towards ICI+CT benefit included women, patients with PD-L1 ≥50% (versus PD-L1 ≥90%), and ECOG performance status 0-1. Subgroups trending towards an ICI benefit included men, and patients with liver or brain metastases. OS, PFS, and ORR were similar in RWE and RCTs for ICI+CT, but for ICI alone, OS, PFS, ORR, and grade ≥3 AEs were generally higher in RCTs than in RWE.
CONCLUSIONS: OS and PFS generally favoured ICI+CT in the identified RWE studies. However, more research is needed to confirm patient subgroups benefiting from ICI+CT or ICI alone. Reported outcomes appear favourable for patients receiving ICI in RCTs than in RWE studies; this discrepancy needs to be understood so that clinicians can make informed treatment decisions.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD140
Topic
Real World Data & Information Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology