2023 World Conference on Lung Cancer (Posters)-P2.06. DEnosumab plus PD-1 Inhibitor for MAINtenance Therapy of Advanced KRAS-Mutant NSCLC - A Prospective, Single-Arm, Phase II Study (DEMAIN)

P2.06. DEnosumab plus PD-1 Inhibitor for MAINtenance Therapy of Advanced KRAS-Mutant NSCLC - A Prospective, Single-Arm, Phase II Study (DEMAIN) - PDF(Slides)

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The DEMAIN study aimed to investigate the efficacy and safety of combining a receptor activator for NF-κB ligand (RANKL) inhibitor with PD-1 inhibitors for the maintenance treatment of advanced KRAS-mutant non-small cell lung cancer (NSCLC). Preclinical models had shown potential efficacy for this combination therapy. The study used a two-stage design, with 20 patients recruited in the first stage and a continuation of recruitment in the second stage.<br /><br />The results showed that median progression-free survival (PFS) for the entire treatment course was 329 days, and for maintenance therapy was 196 days. Tumor lesions shrunk in 36.8% of patients during maintenance, but no partial responses were achieved, resulting in a 0% overall response rate (ORR). Median overall survival (OS) was not reached.<br /><br />The most common adverse events reported were dental symptoms and hypothyroidism, with no grade 3-4 adverse events occurring. Subgroup analysis suggested that patients with KRAS codon 12 mutations and those with bone metastases appeared to benefit more from the therapy.<br /><br />The study suggests that combining a RANKL inhibitor with PD-1 inhibitors may provide a new approach for the treatment of advanced KRAS-mutant NSCLC. However, further research and clinical trials are needed to confirm the efficacy and safety of this combination therapy.

Asset Subtitle

Yan Wang

Meta Tag

Speaker Yan Wang

Topic Metastatic NSCLC: Immunotherapy - Prospective

Keywords

DEMAIN study

efficacy

safety

RANKL inhibitor

PD-1 inhibitors

NSCLC

combination therapy

PFS

adverse events