Interim results from the phase 2 IDeate-Lung01 trial demonstrate promising activity of ifinatamab deruxtecan (I-DXd) in patients with heavily pretreated extensive-stage small cell lung cancer (ES-SCLC). The study, presented at the 2024 IASLC World Conference on Lung Cancer, evaluated the B7-H3–directed antibody-drug conjugate in patients who had progressed after at least one prior line of platinum-based chemotherapy.
The IDeate-Lung01 trial randomly assigned patients to receive I-DXd at either 8 mg/kg or 12 mg/kg every three weeks. According to Triparna Sen, PhD, from the Icahn School of Medicine at Mount Sinai, the interim analysis revealed a significantly higher objective response rate (ORR) in the 12 mg/kg arm.
Efficacy and Safety
The 12 mg/kg dose of I-DXd yielded an ORR of 54.8% (95% CI, 38.7%-70.2%) per blinded independent central review, compared to 26.1% (95% CI, 14.3%-41.1%) in the 8 mg/kg arm. The disease control rate (DCR) was also higher in the 12 mg/kg arm, reaching 90.5% (95% CI, 77.4%-97.3%) versus 80.4% (95% CI, 66.1%-90.6%) in the lower dose arm. However, the median duration of response was shorter in the 12 mg/kg arm at 4.2 months (95% CI, 3.5-7.0) compared to 7.9 months (95% CI, 4.1-not estimable) in the 8 mg/kg arm.
Further Development
Based on these interim findings, the 12 mg/kg dose has been selected as the recommended dose of I-DXd for the second part of the IDeate-Lung01 trial and for the phase 3 IDeate-Lung02 study. Dr. Sen emphasized the need for further research into the toxicity profile of I-DXd and a comprehensive analysis of the complete data from the IDeate-Lung01 study to fully understand the benefit-risk profile of this novel agent in ES-SCLC.
