Phase 3 BrenDeLL-Lung01 tests DLL3-targeted BL-M14D1 plus atezolizumab in first-line extensive-stage SCLC

SystImmune is running this global, open-label, randomized Phase 3 trial in previously untreated extensive-stage small-cell lung cancer. BL-M14D1 is a DLL3-directed antibody-drug conjugate with a topoisomerase I inhibitor payload, and atezolizumab is Genentech/Roche’s PD-L1-blocking antibody. Two experimental groups receive BL-M14D1 plus atezolizumab, compared with a control group receiving carboplatin, etoposide, and atezolizumab induction.

The control proceeds to atezolizumab-based maintenance, with lurbinectedin permitted according to the protocol and regional approval. The study thus evaluates an ADC-based frontline strategy against contemporary induction and maintenance treatment. Its central question is whether a DLL3-targeted ADC can improve outcomes in the frontline setting while avoiding unacceptable toxicity. Its distinctive feature is delivering a cytotoxic payload through DLL3 targeting rather than using DLL3 to redirect T cells.