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(Slides)

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A phase 2 study is being conducted to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a highly aggressive lung malignancy with a low survival rate. B7 homolog 3 (B7-H3) is overexpressed in SCLC and is associated with worse outcomes. I-DXd is a novel B7-H3-directed antibody-drug conjugate that has shown promising clinical activity in heavily pretreated ES-SCLC patients. The study aims to optimize the dose of I-DXd based on efficacy, safety, and pharmacokinetics, and investigate its antitumor activity.<br /><br />The study design involves dose optimization with approximately 40 patients per dose level. The endpoints include objective response rate, safety, progression-free survival, duration of response, overall survival, time to response, disease control rate, pharmacokinetic parameters, and treatment-emergent antidrug antibodies. The eligibility criteria require patients to have ES-SCLC, Eastern Cooperative Oncology Group performance status of 0-1, and prior treatment with one platinum-based regimen and three previous regimens.<br /><br />The results so far demonstrate a 52% objective response rate in ES-SCLC patients treated with I-DXd. The study also stratifies patients based on chemotherapy-free interval in second-line subjects and the number of previous lines, as well as prior treatment with PD-L1 antibodies.<br /><br />The study is ongoing, with dose optimization completed and 91 patients enrolled and dosed. Enrollment has been extended, and the estimated primary completion date is in May 2024.<br /><br />Funding for the study is provided by Daiichi Sankyo, Inc. Medical writing support was provided by a third-party agency, and permission is required for reproduction of the poster.

Asset Subtitle

Melissa Johnson

Meta Tag

Speaker Melissa Johnson

Topic SCLC & Neuroendocrine Tumors: Trials in Progress

Keywords

phase 2 study

ifinatamab deruxtecan

extensive-stage small cell lung cancer

ES-SCLC

B7 homolog 3

I-DXd

antibody-drug conjugate

dose optimization

objective response rate

pharmacokinetic parameters