2024 World Conference on Lung Cancer (WCLC) - Posters-P2.10A.03 RESOLUTION: Phase II Study of Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in Patients with HER2 Alteration Advanced NSCLC

P2.10A.03 RESOLUTION: Phase II Study of Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in Patients with HER2 Alteration Advanced NSCLC

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The Phase II study, led by Jianing Chen and Chunxia Su, explores a novel treatment combination for advanced non-small cell lung cancer (NSCLC) with HER2 alterations. Currently, there are limited targeted therapies approved for metastatic NSCLC with such genetic modifications. The study evaluates disitamab vedotin (RC48), an antibody-drug conjugate, which targets and kills tumor cells by delivering a tubulin inhibitor specifically to HER2 proteins on these cells. Disitamab vedotin has previously shown significant anti-tumor effects in solid tumors. <br /><br />The study aims to investigate the potential synergy of combining disitamab vedotin with two other drugs: tislelizumab, an immunotherapy agent, and bevacizumab, an anti-vascular drug, in treating HER2-altered NSCLC. This combination therapy is hypothesized to enhance the efficacy in treating this cancer type.<br /><br />The clinical trial, named RESOLUTION (ChiCTR2300077938), is a dual-cohort, phase 2 study. It aims to enroll 56 patients with locally advanced or metastatic NSCLC exhibiting HER2 alterations. These patients are divided into two cohorts: those who have received one line of systemic therapy and those who have not received any prior systemic treatment.<br /><br />The primary endpoint of this study is the objective response rate (ORR), which measures the proportion of patients with tumor size reduction. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Disease response is assessed by investigators using the RECIST 1.1 criteria, which provide a standard way to measure how well cancer treatments work.<br /><br />Patient enrollment is ongoing, and the study is conducted by the Department of Oncology at Shanghai Pulmonary Hospital, Tongji University. This research could lead to new, more effective treatment options for patients with HER2-altered NSCLC.

Asset Subtitle

Jianing Chen

Meta Tag

Speaker Jianing Chen

Topic Metastatic NSCLC – Cytotoxic Therapy

Keywords

Phase II study

NSCLC

HER2 alterations

disitamab vedotin

antibody-drug conjugate

tislelizumab

bevacizumab

RESOLUTION trial

objective response rate

Shanghai Pulmonary Hospital