Systematic Literature Review and Bayesian Network Meta-Analysis of Sugemalimab Plus Chemotherapy vs. Other First-Line Treatments for Metastatic Non-Small Cell Lung Cancer Without Sensitizing eGFR, ALK, ROS1, or RET Alterations
Author(s)
Aneta Gomulka-Pilat, MSc, Magdalena Kaczanowska, MSc, Agnieszka Kopiec, MSc, Izabela Pieniazek, MSc.
Evidence and Access, Certara, Cracow, Poland.
Evidence and Access, Certara, Cracow, Poland.
OBJECTIVES: The therapeutic landscape of metastatic non-small cell lung cancer (mNSCLC) has evolved with the advent of immunotherapy, providing significant clinical benefits. However, the absence of direct head-to-head trials among PD-1/PD-L1 inhibitors limits comparative effectiveness assessment. Furthermore, existing network meta-analyses (NMAs) do not reflect the most up-to-date evidence or long-term outcomes from currently available clinical trials. The objective was to evaluate comparative efficacy and safety of sugemalimab plus chemotherapy versus other PD-1/PD-L1 inhibitor-based regimens in patients with first line (1L) mNSCLC without sensitizing EGFR mutations or ALK, ROS1, or RET genomic alterations.
METHODS: A systematic literature review (SLR) was conducted to identify randomized controlled trials evaluating sugemalimab and specific PD-1/PD-L1 inhibitors, that are approved by the European Medicines Agency for the 1L mNSCLC. A feasibility assessment confirmed the appropriateness of conducting an indirect comparison and informed them of the selection of suitable methodological approaches. Bayesian NMAs with random effects model were conducted to assess progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety.
RESULTS: Sugemalimab plus chemotherapy consistently demonstrated numerical improvements in PFS compared to other PD-1/PD-L1 regimens, with SUCRA analyses frequently ranking it among the top treatments across histological subtypes and PD-L1 expression levels. However, these differences did not reach statistical significance. No clear advantage was observed for sugemalimab in OS or ORR. The safety profile of sugemalimab plus chemotherapy was generally comparable to other ICI+ChT regimens across predefined endpoints, including any adverse events (AEs), grade 3-5 AEs, serious AEs, immune-related AEs, and AEs leading to treatment discontinuation or death.
CONCLUSIONS: Sugemalimab plus chemotherapy demonstrated comparable efficacy and safety to other 1L PD-1/PD-L1-based regimens in mNSCLC patients without oncogenic drivers, supporting its use across a broad patient population.
METHODS: A systematic literature review (SLR) was conducted to identify randomized controlled trials evaluating sugemalimab and specific PD-1/PD-L1 inhibitors, that are approved by the European Medicines Agency for the 1L mNSCLC. A feasibility assessment confirmed the appropriateness of conducting an indirect comparison and informed them of the selection of suitable methodological approaches. Bayesian NMAs with random effects model were conducted to assess progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety.
RESULTS: Sugemalimab plus chemotherapy consistently demonstrated numerical improvements in PFS compared to other PD-1/PD-L1 regimens, with SUCRA analyses frequently ranking it among the top treatments across histological subtypes and PD-L1 expression levels. However, these differences did not reach statistical significance. No clear advantage was observed for sugemalimab in OS or ORR. The safety profile of sugemalimab plus chemotherapy was generally comparable to other ICI+ChT regimens across predefined endpoints, including any adverse events (AEs), grade 3-5 AEs, serious AEs, immune-related AEs, and AEs leading to treatment discontinuation or death.
CONCLUSIONS: Sugemalimab plus chemotherapy demonstrated comparable efficacy and safety to other 1L PD-1/PD-L1-based regimens in mNSCLC patients without oncogenic drivers, supporting its use across a broad patient population.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO227
Topic
Clinical Outcomes, Health Technology Assessment, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology