Datopotamab Deruxtecan (Dato-DXd) plus Durvalumab ± Carboplatin in Advanced/mNSCLC: Initial Results from Phase 1b TROPION-Lung04

Abstract

to 16.0 mg/kg. Results: As of the data cutoff of 31 January 2023, 21 patients with SCLC were evaluable for safety, response, PFS, and OS. Treatment was ongoing in 2 patients. Patients received a median 2 (range, 1-9) prior lines of therapy; the majority were treated with platinum-based chemotherapy and immunotherapy. The safety profile was consistent with previous reports. Eleven patients experienced a confirmed objective response (52%; 1 complete response and 10 partial responses), and the median duration of response was 5.9 months (95% CI, 2.8-7.5). The median PFS was 5.8 months (95% CI, 3.9-8.1), and the median OS was 9.9 months (5.8-NR). Sixteen patients were evaluable for B7-H3 analysis (data cutoff of 30 June 2022). The level of B7-H3 expression was moderate to high across all evaluable participants. There were no trends of association observed between best overall response or tumor reduction and B7-H3 positivity or intensity, although a larger sample size is needed to confirm these results. Updated analysis of B7-H3 correlations will be presented at the congress. Conclusions: I-DXd demonstrated robust and durable efficacy in this subset of patients with heavily pretreated SCLC. Likewise, it was tolerable with manageable toxicity. A phase 2 study (NCT05280470) of patients with second-or third-line extensive stage SCLC only is currently ongoing.