Ifinatamab Deruxtecan in Patients With Extensive-Stage Small-Cell Lung Cancer: Primary Analysis of the Phase 2 IDeate-Lung01 Trial

1. In patients with previously treated extensive-stage small-cell lung cancer (ES-SCLC), treatment with ifinatam deruxtecan (I-DXd) showed promising efficacy with an objective response rate (ORR) of 48.2% and a 9-month overall survival (OS) estimate of 59.1%. 

Evidence Rating Level: 1 (Excellent)

Patients with ES-SCLC currently have a very poor prognosis, with a lack of an accepted standard-of-care therapy after first-line chemoimmunotherapy. I-DXd is a novel antibody-drug conjugate which has shown promising efficacy in patients with previously treated SCLC in the phase 1 IDeate-PanTumour01 trial. The IDeate-Lung01 trial is therefore a phase 2 trial designed to investigate the efficacy and safety of I-DXd in patients with previously treated ES-SCLC. Between May 2022 and June 2024, 183 patients over the age of 18 with ES-SCLC previously treated with between 1 and 3 lines of systemic therapy were included in the study, with 88 patients enrolled in the dose optimization portion of the study and 95 enrolled in the extension portion of the study. In patients receiving the highest dose (12-mg/kg group), the confirmed ORR was 48.2% (95% CI, 39.6-56.9%) with a progression-free survival at 6 and 9 months of 35.3% (95% CI, 27.3-43.4%) and 19.3% (95% CI, 12.9-26.5%), respectively. The median OS was 10.3 months (95% CI, 9.1-13.3%). Among the 12-mg/kg group, treatment-emergent adverse events (TEAEs) were reported in 39.4% (54/137) of patients, with TEAEs associated with death being reported in 6 patients. Overall, this phase 2 study found that in patients with ES-SCLC, treatment with I-DXd showed promising efficacy with a manageable safety profile.  

Click here to read this study in The Journal of Clinical Oncology

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