2022 World Conference on Lung Cancer (Posters)-P1.11-01. Cobolimab With Dostarlimab and Docetaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC): COSTAR Lung

P1.11-01. Cobolimab With Dostarlimab and Docetaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC): COSTAR Lung

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The COSTAR Lung study aims to compare the efficacy and safety of cobolimab plus dostarlimab plus standard of care chemotherapy (docetaxel) with dostarlimab plus docetaxel and docetaxel alone in patients with relapsed/refractory non-small cell lung cancer (NSCLC) that has been treated with PD-1/PD-L1 inhibitors. The study will be conducted in several countries, including Germany, Netherlands, France, UK, Spain, Italy, Sweden, Poland, Romania, Russian Federation, Republic of Korea, Australia, Argentina, Brazil, Mexico, USA, and Canada. Participants must meet specific criteria, including having advanced or metastatic NSCLC, having received two lines of therapy, having measurable disease, and documented radiographic disease progression on prior treatment. The study will have three phases: screening, treatment, and follow-up. Cobolimab was chosen based on the results of a Phase 1 study and will be administered at a dose of 300 mg. Participants will be stratified according to prior lines of therapy, PD-L1 status, and histology. The primary endpoints of the study are overall survival (OS) and the secondary endpoints include objective response rate, progression-free survival, duration of response, and time to treatment discontinuation. Exploratory endpoints include biomarkers of response, patient-reported efficacy and tolerability, and healthcare resource utilization. The study will also conduct a futility analysis to assess objective response rate in the Phase 2 portion. The study is ongoing and has the potential for Phase III expansion. The authors note that immune checkpoint inhibitors targeting PD-(L)1 are approved in the first-line setting for lung cancer treatment, but resistance to these therapies is common and novel immunotherapy combinations are needed. Cobolimab, a novel anti-TIM-3 monoclonal antibody, has shown promising results in early clinical studies when combined with anti-PD-1 mAb dostarlimab.

Asset Subtitle

Hye Ryun Kim, South Korea

Meta Tag

Speaker Hye Ryun Kim, South Korea

Topic Locally Advanced Non-small Cell Lung Cancer - Neoadjuvant and Adjuvant Therapy

Keywords

COSTAR Lung study

cobolimab

dostarlimab

chemotherapy

non-small cell lung cancer

relapsed/refractory

PD-1/PD-L1 inhibitors

clinical trial

overall survival

immune checkpoint inhibitors