2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.11D.02 An Investigator-Initiated Phase II Study of Combination Treatment of Nivolumab and TM5614, A PAI-1 Inhibitor for Previously Treated NSCLC

EP.11D.02 An Investigator-Initiated Phase II Study of Combination Treatment of Nivolumab and TM5614, A PAI-1 Inhibitor for Previously Treated NSCLC

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The document summarizes an investigator-initiated Phase II study conducted by Takeshi Masuda and colleagues aimed at evaluating a combination treatment with Nivolumab and TM5614 for previously treated non-small cell lung cancer (NSCLC) patients. The study involves multiple institutions in Japan, including Hiroshima University Hospital, and investigates the efficacy and safety of this novel treatment combination.<br /><br />The background of the study highlights the urgent need for effective third-line treatments for advanced NSCLC, as current options are limited following the progression after first- and second-line treatments. A significant challenge lies in patients who exhibit driver mutation-negative status, indicating a poorer prognosis. The study seeks to improve outcomes using TM5614, a PAI-1 inhibitor, in combination with Nivolumab, an anti-PD-1 antibody.<br /><br />PAI-1 is a glycoprotein implicated in cancer progression, linked to higher malignancy and treatment resistance in cancer cells. TM5614 is developed to inhibit PAI-1's interactions, enhancing the immune system's response when combined with Nivolumab. The combination therapy aims to convert a tumor-immune microenvironment into a more supportive one, potentially increasing the response rate compared to existing treatments and addressing resistance issues linked to PAI-1.<br /><br />The Phase II trial, registered under the Japan Registry of Clinical Trials, enrolls NSCLC patients meeting specific criteria, including those previously treated with platinum doublet chemotherapy and immune-checkpoint inhibitors. The study's primary endpoint is the objective response rate, with secondary outcomes focusing on survival rates and disease control. As of August 2024, 20 participants have been enrolled, with the trial anticipating a total of 39 patients. The study acknowledges various contributors and institutions supporting the research, including Renascience Inc. and several Japanese medical facilities.

Asset Subtitle

Takeshi Masuda

Meta Tag

Speaker Takeshi Masuda

Topic Metastatic Non-small Cell Lung Cancer – Immunotherapy

Keywords

Phase II study

Nivolumab

TM5614

non-small cell lung cancer

NSCLC

PAI-1 inhibitor

immune checkpoint inhibitors

objective response rate

Japan Registry of Clinical Trials

third-line treatments