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(Abstract)

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A prospective, single-arm, phase II study called DEMAIN was conducted to evaluate the efficacy and safety of combining the receptor activator for NF-κB ligand (RANKL) inhibitor denosumab with PD-1 inhibitors for the maintenance therapy of advanced KRAS-mutant non-small cell lung cancer (NSCLC). The study enrolled 20 patients in the first stage, with an additional 20 patients to be recruited in the second stage.<br /><br />The primary endpoint of the study was progression-free survival (PFS) and secondary endpoints included objective response rate (ORR), overall survival (OS), and safety. The initial results showed that the combination therapy demonstrated anti-tumor activity in advanced KRAS-mutant NSCLC with a good safety profile. The median PFS for the entire treatment course was 329 days, with a median PFS of 196 days during maintenance therapy. However, no objective responses were observed and the overall survival median was not reached.<br /><br />The most common adverse events were dental symptoms and hypothyroidism, with no grade 3-4 adverse events reported. One patient discontinued treatment due to grade 2 immuno-hepatitis. Subgroup analysis suggested that patients with KRAS codon 12 mutations had a greater survival benefit compared to those with non-codon 12 mutations. Additionally, patients with bone metastases appeared to benefit more from the combination therapy.<br /><br />These findings support further investigation into the combination of denosumab and PD-1 inhibitors for the treatment of advanced KRAS-mutant NSCLC. The study provides important insights into the potential efficacy and safety of this treatment approach, which could address the unmet need for effective therapies for patients with KRAS-mutated NSCLC.

Asset Subtitle

Yan Wang

Meta Tag

Speaker Yan Wang

Topic Metastatic NSCLC: Immunotherapy - Prospective

Keywords

DEMAIN study

phase II

efficacy

safety

denosumab

PD-1 inhibitors

KRAS-mutant NSCLC

progression-free survival

overall survival

treatment approach