Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study
Recommended Citation
Patel MR, Doi T, Koyama T, Falchook GS, Friedman CF, Piha-Paul SA, Gutierrez M, Awad MM, Mattour AH, Satoh T, Okamoto N, Singh J, Yoshizuka N, Qian M, Qian X., Tran BP, Dosunmu O, Lu P, Johnson ML. Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study. Ann Oncol 2023; 34:S481-S482.
Document Type
Conference Proceeding
Publication Date
10-1-2023
Publication Title
Ann Oncol
Abstract
Background: I-DXd is a novel B7-H3–directed antibody–drug conjugate that leverages the clinically validated deruxtecan (DXd) technology with a plasma-stable linker and potent topoisomerase I inhibitor payload. Here we present a follow-up analysis (7 mo since last report) of an ongoing phase 1/2 trial that includes heavily pretreated patients with castration-resistant prostate cancer (CRPC), esophageal squamous cell carcinoma (ESCC), squamous non-small cell lung cancer (sqNSCLC), and small cell lung cancer (SCLC). DOR, OS, and B7-H3 correlations with response are reported for the first time for CRPC, ESCC, and sqNSCLC. Methods: Efficacy and safety were analyzed in patients treated with I-DXd at 4.8 to 16.0 mg/kg. Response was evaluated in patients with ≥2 postbaseline scans or discontinuation for any reason. Fourteen patients with CRPC lacked measurable target lesions at baseline (BL) and were excluded from ORR analysis. B7-H3 level was evaluated retrospectively as patients were not pre-selected by BL expression. Results: As of 31 Jan 2023, 8 patients remained on treatment. Safety data were consistent with previous reports. I-DXd still demonstrated promising ORR results, including in an updated sample size for sqNSCLC (Table). Even in this heavily pretreated population, I-DXd exhibited durable response and encouraging early OS (Table), although further follow-up is needed. B7-H3 expression was moderate to high in most patients; no correlation was observed between response and B7-H3 level, and an update will be presented at the congress. [Formula presented] Conclusions: I-DXd continues to demonstrate a manageable safety profile and promising antitumor activity with encouraging DOR and OS in these heavily pretreated patients, which warrants further clinical evaluation across multiple indications. Clinical trial identification: NCT04145622.
Medical Subject Headings
Hematology
PubMed ID
Not assigned.
Volume
34
First Page
S481
Last Page
S482