2023 World Conference on Lung Cancer (Posters)-P2.16. A Phase 2 Study of Ifinatamab Deruxtecan (I-DXd; DS-7300) in Patients with Previously Treated ES-SCLC

P2.16. A Phase 2 Study of Ifinatamab Deruxtecan (I-DXd; DS-7300) in Patients with Previously Treated ES-SCLC - PDF(Abstract)

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A phase 2 study is underway to investigate the efficacy of Ifinatamab Deruxtecan (I-DXd) in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a highly aggressive form of lung cancer with limited treatment options in later stages of the disease. I-DXd is a novel antibody-drug conjugate that targets the B7 homolog 3 protein (B7-H3), which is overexpressed in SCLC and associated with poor prognosis.<br /><br />The study, known as DS7300-127, aims to establish the recommended phase 2 dose of I-DXd and evaluate its efficacy in ES-SCLC. The first-in-human study of I-DXd showed promising results in patients with SCLC, with 11 out of 21 patients demonstrating a tumor response. The DS7300-127 study will enroll patients with ES-SCLC who have received 1 to 3 prior lines of therapy and have an Eastern Cooperative Oncology Group performance status of 0 or 1.<br /><br />Patients will be randomized to receive either 8 mg/kg or 12 mg/kg of I-DXd intravenously on day 1 of each 21-day cycle. The primary endpoint of the study is objective response rate, assessed by blinded independent central review. Secondary endpoints include progression-free survival, duration of response, disease control rate, and overall survival.<br /><br />The study will also assess safety, pharmacokinetics, exposure-response, immunogenicity, and biomarkers. Enrollment in the dose-optimization part of the study is expected to be completed by April 2023. Based on a protocol amendment, an additional 100 patients may be enrolled at the recommended phase 2 dose, following consultation with the study steering committee.<br /><br />The estimated completion date for the study is November 2024. This phase 2 study represents an important step in evaluating the potential of I-DXd as a treatment option for patients with previously treated ES-SCLC.

Asset Subtitle

Melissa Johnson

Meta Tag

Speaker Melissa Johnson

Topic SCLC & Neuroendocrine Tumors: Trials in Progress

Keywords

phase 2 study

Ifinatamab Deruxtecan

I-DXd

extensive-stage small cell lung cancer

ES-SCLC

antibody-drug conjugate

B7 homolog 3 protein

B7-H3

tumor response

recommended phase 2 dose