2022 World Conference on Lung Cancer (ePosters)-EP08.01-081. A Phase I Dose-Escalation Study of HBM4003, an anti-CTLA-4 Heavy Chain Only Monoclonal Antibody, in Combination with Pembrolizumab

EP08.01-081. A Phase I Dose-Escalation Study of HBM4003, an anti-CTLA-4 Heavy Chain Only Monoclonal Antibody, in Combination with Pembrolizumab

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A Phase I study was conducted to evaluate the safety, tolerability, and recommended dosage of HBM4003, an anti-CTLA-4 monoclonal antibody, in combination with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. A total of 16 patients were enrolled, and preliminary results showed that the combination therapy had a favorable safety profile and demonstrated preliminary evidence of antitumor activity in heavily pretreated NSCLC patients, including those with low CD8 T cell infiltration, PD-L1 negativity, or EGFR mutation. The most common adverse events related to the treatment were rash and anemia. Grade 3 treatment-related adverse events occurred in 12.5% of patients, but all were manageable and reversible. The maximum tolerated dose was not reached, and a dose of HBM4003 0.45 mg/kg and pembrolizumab 200 mg every 3 weeks was selected as the recommended phase II dose. Pharmacokinetic analysis showed dose-proportional exposure with a relatively short half-life. In terms of efficacy, reductions in tumor size were observed in some patients, particularly those with EGFR exon 19 deletions or PD-L1 TPS 1%. T-cell proliferation increased in all patients after treatment. Overall, the combination of HBM4003 and pembrolizumab showed promise as a potential treatment option for advanced NSCLC and other solid tumors. Further studies are planned to validate these findings and explore its use in larger patient populations.

Asset Subtitle

Shun Lu

Meta Tag

Speaker Shun Lu

Topic Metastatic Non-small Cell Lung Cancer - Immunotherapy

Keywords

Phase I study

safety

HBM4003

pembrolizumab

NSCLC

solid tumors

adverse events

tumor size reduction

EGFR mutation

efficacy