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Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
Published on: September 25, 2018
Alirocumab plus cemiplimab in advanced immuno-refractory metastatic non-small cell lung cancer: an ongoing
Eziafa I Oduah1,2, Tian Zhang1,2, Sin-Ho Jung2,3
1Department of Medicine, Division of Medical Oncology, Duke University School of Medicine, Durham, NC, USA.
Abstract:
Immunotherapy resistance represents a major unmet clinical need for patients with metastatic non-small cell lung cancer (NSCLC). Preclinical studies have identified PCSK9 as an immunosuppressive regulator of antigen presentation, providing a compelling rationale for therapeutic PCSK9 inhibition as a strategy to overcome resistance to immune checkpoint blockade. Building on this evidence, we present the scientific rationale and study design of TOP2201, an ongoing single-arm phase II trial evaluating the addition of the PCSK9 inhibitor alirocumab to anti-PD-1 therapy in patients with metastatic NSCLC who have experienced disease progression on prior immune checkpoint inhibitor-based regimens. The primary endpoint is objective response rate, with secondary endpoints assessing additional efficacy outcomes and safety. Findings from TOP2201 are expected to generate preliminary clinical and safety data on this combination strategy in the immunorefractory NSCLC setting.Clinical Trial Registration: www.clinicaltrials.gov identifier is NCT05553834.
Insights
This Phase II trial investigates adding alirocumab to anti-PD-1 therapy for metastatic non-small cell lung cancer (NSCLC) patients resistant to immunotherapy. The study aims to improve response rates in advanced NSCLC by targeting PCSK9.
Area of Science:
- Oncology
- Immunology
- Pharmacology
Background:
- Immunotherapy resistance is a significant challenge in metastatic non-small cell lung cancer (NSCLC).
- PCSK9 is implicated as an immunosuppressive factor affecting antigen presentation.
- Targeting PCSK9 may enhance immune checkpoint blockade efficacy.
Purpose of the Study:
- To evaluate the addition of PCSK9 inhibitor alirocumab to anti-PD-1 therapy.
- To assess the efficacy and safety of this combination in patients with pre-treated metastatic NSCLC.
- To investigate a novel strategy for overcoming immunotherapy resistance in NSCLC.
Main Methods:
- Single-arm, Phase II clinical trial (TOP2201).
- Participants: Metastatic NSCLC patients with progression on prior immune checkpoint inhibitors.
- Intervention: Combination of alirocumab (PCSK9 inhibitor) and anti-PD-1 therapy.
Main Results:
- Primary endpoint: Objective response rate.
- Secondary endpoints: Additional efficacy measures and safety assessments.
- Expected to provide preliminary clinical and safety data for the combination therapy.
Conclusions:
- The TOP2201 trial will assess a novel therapeutic approach for immunotherapy-refractory NSCLC.
- Findings may support PCSK9 inhibition as a strategy to enhance anti-PD-1 therapy effectiveness.
- The study aims to address a critical unmet need in advanced NSCLC treatment.
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