Related Experiment Video
Updated: Sep 5, 2025

07:59
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
1.2K
Comprehensive Genome Profiling in Patients With Metastatic Non-Small Cell Lung Cancer: The Precision Medicine Phase
Fabrice Barlesi1,2, Pascale Tomasini2, Maryam Karimi3,4
1Department of Medical Oncology, Gustave Roussy, Villejuif, France.
Summary
Targeted therapies and immune checkpoint blockers showed no significant benefit as maintenance therapy for advanced non-small cell lung cancer (NSCLC) patients. Durvalumab demonstrated a survival benefit only in patients with high PD-L1 expression.
Area of Science:
- Oncology
- Genetics
- Pharmacology
Background:
- Targeted therapies (TT) and immune checkpoint blockers (ICB) have transformed non-small cell lung cancer (NSCLC) treatment.
- The role of these therapies as maintenance treatment based on molecular profiling remains unclear.
Purpose of the Study:
- To evaluate the efficacy of TT and ICB as maintenance therapy in advanced EGFR, ALK wild-type (wt) NSCLC.
- To assess the impact of molecular characterization on treatment selection for maintenance strategies.
Main Methods:
- A randomized phase II trial (SAFIR02-Lung/IFCT 1301) involving 33 centers.
- Patients with advanced EGFR/ALK wt NSCLC, without progression after first-line chemotherapy, were randomized to receive either TT (substudy-1) or ICB (substudy-2) versus standard-of-care.
- High-throughput genome analysis was used for molecular characterization.
Main Results:
- In substudy-1, median progression-free survival (PFS) was 2.7 months for TT and 2.7 months for standard-of-care (HR, 0.97; P = 0.87).
- In substudy-2, median PFS was 3.0 months for durvalumab and 3.0 months for standard-of-care (HR, 0.86; P = 0.38).
- Durvalumab showed improved PFS in patients with PD-L1 tumor proportion score (TPS) ≥1% (HR, 0.29) compared to PD-L1 <1% (HR, 0.71; Pinteraction = 0.036).
Conclusions:
- Molecular profiling is feasible for guiding maintenance therapy in EGFR/ALK wt NSCLC.
- The study did not demonstrate substantial treatment benefits with TT or ICB as maintenance therapy, except for durvalumab in patients with PD-L1 TPS ≥1%.

