2024 World Conference on Lung Cancer (WCLC) - Posters-P2.10A.01 Phase 2 Study of Disitamab Vedotin in Patients with HER2-Expressing Non-Small Cell Lung Cancer (DV-005; Trial in Progress)

P2.10A.01 Phase 2 Study of Disitamab Vedotin in Patients with HER2-Expressing Non-Small Cell Lung Cancer (DV-005; Trial in Progress)

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Pdf Summary

The document outlines a Phase 2 study, SGNDV-005, investigating disitamab vedotin (DV) as a monotherapy for patients with HER2-expressing non-small cell lung cancer (NSCLC) and other solid tumors. This trial is currently ongoing across various international sites, including Australia, Canada, and the United States, with additional sites planned throughout Europe and Asia.<br /><br />Disitamab vedotin is an investigational antibody-drug conjugate (ADC) targeting HER2, comprising a monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker. It aims to treat patients with HER2-expressing advanced solid tumors, particularly those with limited second-line (2L) treatment options following disease progression on initial therapies.<br /><br />Eligibility for the study requires patients to have HER2 IHC expression with previously treated, unresectable, or metastatic cancer. The trial includes several cohorts, notably involving NSCLC and head and neck squamous cell carcinoma (HNSCC) patients, with additional cohorts for ovarian and endometrial cancers.<br /><br />Primary objectives of the study include assessing the anti-tumor activity of DV, measured by the objective response rate (ORR) according to RECIST 1.1 criteria, and evaluating its safety profile through monitoring of adverse events and laboratory abnormalities. Secondary endpoints include disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), pharmacokinetics (PK), and immunogenicity.<br /><br />The study represents a vital exploration into addressing the unmet need in 2L therapies for specific cancer types, leveraging DV's multimodal mechanisms for potentially improved outcomes.<br /><br />The study is funded by Seagen Inc., a company acquired by Pfizer, and involves researchers from multiple leading medical institutions. The design and conduct of the trial stress the importance of further investigating ADC therapies in oncology for enhanced treatment options.

Asset Subtitle

Jonathan Riess

Meta Tag

Speaker Jonathan Riess

Topic Metastatic NSCLC – Cytotoxic Therapy

Keywords

Phase 2 study

disitamab vedotin

HER2-expressing

non-small cell lung cancer

antibody-drug conjugate

monomethyl auristatin E

objective response rate

progression-free survival

Seagen Inc.

Pfizer