EFFICACY AND SAFETY EVIDENCE ASSOCIATED WITH FIRST-LINE TREATMENTS FOR PATIENTS WITH PD-L1 =50% ADVANCED NSCLC: A SYSTEMATIC LITERATURE REVIEW
Author(s)
Jhanelle E. Gray, MD1, Ryan Thaliffdeen, MS, PharmD2, Indy Kaur Dhillon, PhD3, Marissa West, PharmD2, Alex Pashley, MChem4, Emma Worthington, BSc, MPH4, Hannah Russell, MSci5, Aaron Lisberg, MD6.
1Moffitt Cancer Center, Tampa, FL, USA, 2Gilead Sciences, Foster City, CA, USA, 3Gilead Sciences, Stockley Park, United Kingdom, 4Costello Medical, Cambridge, United Kingdom, 5Costello Medical, Manchester, United Kingdom, 6David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
1Moffitt Cancer Center, Tampa, FL, USA, 2Gilead Sciences, Foster City, CA, USA, 3Gilead Sciences, Stockley Park, United Kingdom, 4Costello Medical, Cambridge, United Kingdom, 5Costello Medical, Manchester, United Kingdom, 6David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
OBJECTIVES: Immunotherapy±chemotherapy is the current first-line (1L) treatment for advanced non-small cell lung cancer (aNSCLC) without actionable genomic alterations (AGAs). However, patients still experience disease progression, even as treatment options expand. This systematic literature review (SLR) identified studies reporting efficacy/safety of 1L treatments for patients with PD-L1 ≥50% aNSCLC, ineligible for definitive chemoradiation/surgery and without AGAs.
METHODS: Electronic databases were searched from 2015-2025 and supplemented with hand searches. Randomised controlled trials including patients with PD-L1 ≥50% aNSCLC and without AGAs, treated with 1L PD-(L)1 therapy, were included, extracted and quality-appraised.
RESULTS: Of 4,462 publications, 42 studies reported on patients with PD-L1 ≥50%; baseline characteristics were heterogeneous where reported (n=8). Median overall survival (OS; n=19) ranged from 15.8-43.4 and 11-30 months with PD-(L)1+chemotherapy and PD-(L)1 monotherapy, respectively. In global studies, median OS was similar between regimens (PD-[L]1+chemotherapy: 15.8-27.7 months [n=6]; PD-[L]1 monotherapy: 11-30 months [n=9]). In Asia-based studies, median OS of PD-(L)1+chemotherapy (33.4-43.4 [n=3]) was higher versus global studies. Across all studies of PD-(L)1+chemotherapy and PD-(L)1 monotherapy regimens, median progression-free survival (PFS; n=26) ranged from 6.4-21 and 5.6-11.1 months, and overall response rate (ORR; n=25) ranged from 44-85.7% and 30.6-74%, respectively. PFS and ORR ranges were similar between geographies. Median duration of response (DoR; n=15) ranged from 7.3-29.1 and 10.4-26.0 months, respectively. Grade ≥3 TRAEs were reported in 52% of patients receiving PD-(L)1+chemotherapy (n=1) and 16-46.2% (n=7; median: 26.6%) receiving PD-(L)1 monotherapy.
CONCLUSIONS: Despite heterogeneity, PD-(L)1+chemotherapy yielded numerically higher PFS and ORR ranges than PD-(L)1 monotherapy across studies. Asia-based studies reported higher OS for PD-(L)1+chemotherapy versus PD-(L)1 monotherapy, whereas OS rates were comparable across global studies. These findings indicate a global unmet need for new 1L treatments for these patients; any indirect comparisons will require robust heterogeneity assessment prior to conduct.
METHODS: Electronic databases were searched from 2015-2025 and supplemented with hand searches. Randomised controlled trials including patients with PD-L1 ≥50% aNSCLC and without AGAs, treated with 1L PD-(L)1 therapy, were included, extracted and quality-appraised.
RESULTS: Of 4,462 publications, 42 studies reported on patients with PD-L1 ≥50%; baseline characteristics were heterogeneous where reported (n=8). Median overall survival (OS; n=19) ranged from 15.8-43.4 and 11-30 months with PD-(L)1+chemotherapy and PD-(L)1 monotherapy, respectively. In global studies, median OS was similar between regimens (PD-[L]1+chemotherapy: 15.8-27.7 months [n=6]; PD-[L]1 monotherapy: 11-30 months [n=9]). In Asia-based studies, median OS of PD-(L)1+chemotherapy (33.4-43.4 [n=3]) was higher versus global studies. Across all studies of PD-(L)1+chemotherapy and PD-(L)1 monotherapy regimens, median progression-free survival (PFS; n=26) ranged from 6.4-21 and 5.6-11.1 months, and overall response rate (ORR; n=25) ranged from 44-85.7% and 30.6-74%, respectively. PFS and ORR ranges were similar between geographies. Median duration of response (DoR; n=15) ranged from 7.3-29.1 and 10.4-26.0 months, respectively. Grade ≥3 TRAEs were reported in 52% of patients receiving PD-(L)1+chemotherapy (n=1) and 16-46.2% (n=7; median: 26.6%) receiving PD-(L)1 monotherapy.
CONCLUSIONS: Despite heterogeneity, PD-(L)1+chemotherapy yielded numerically higher PFS and ORR ranges than PD-(L)1 monotherapy across studies. Asia-based studies reported higher OS for PD-(L)1+chemotherapy versus PD-(L)1 monotherapy, whereas OS rates were comparable across global studies. These findings indicate a global unmet need for new 1L treatments for these patients; any indirect comparisons will require robust heterogeneity assessment prior to conduct.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO167
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology