Dr Sen on Interim IDeate-Lung01 Data in Extensive-Stage SCLC

Triparna Sen, PhD, cell and molecular biologist, associate professor, Department of Oncological Sciences, director, Lung Cancer PDX Platform, Icahn School of Medicine at Mount Sinai, discusses findings from an interim analysis of the phase 2 IDeate-Lung01 trial (NCT05280470), which is evaluating the B7-H3–directed antibody-drug conjugate ifinatamab deruxtecan (I-DXd) in patients with extensive-stage small cell lung cancer.

IDeate-Lung01 enrolled patients who had undergone at least 1 line of prior platinum-based chemotherapy and no more than 3 prior lines of systemic therapy. Patients were randomly assigned 1:1 to receive I-DXd every 3 weeks at a dose of 8 mg/kg (n = 46) or 12 mg/kg (n = 42), Sen explains.

Data from an interim analysis of IDeate-Lung01 presented during the 2024 IASLC World Conference on Lung Cancer demonstrated that patients who received the 12 mg/kg dose achieved an objective response rate per blinded independent central review of 54.8% (95% CI, 38.7%-70.2%) compared with 26.1% (95% CI, 14.3%-41.1%) in the 8 mg/kg arm, Sen says. The disease control rate (DCR) was 90.5% (95% CI, 77.4%-97.3%) vs 80.4% (95% CI, 66.1%-90.6%), respectively. However, the median duration of response was 4.2 months (95% CI, 3.5-7.0) compared with 7.9 months (95% CI, 4.1-not estimable).

The 12 mg/kg dose was selected as the recommended dose of I-DXd for the second part of IDeate-Lung01 and for the phase 3 IDeate-Lung02 study (NCT06203210). Although these data are promising, further research into the toxicity profile of I-DXd is needed and the full data from the study will need to be analyzed, Sen concludes.