SystImmune has dosed the first patient in its global Phase 3 BrenDeLL-Lung01 trial, which is evaluating the investigational antibody-drug conjugate (ADC) BL-M14D1 in combination with atezolizumab as a first-line treatment for patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

BL-M14D1 is a DLL3-targeted ADC developed using SystImmune's proprietary brengitecan platform. The therapy is being developed for the treatment of small cell lung cancer and other neuroendocrine cancers.

The Phase 3 programme follows positive findings from the ongoing Phase 1 BL-M14D1-101 study, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The early-stage trial showed encouraging anti-tumour activity and a manageable safety profile in heavily pre-treated patients with small cell lung cancer and other neuroendocrine carcinomas, supporting the move into late-stage clinical development.

BrenDeLL-Lung01 (NCT07625644) is a global, multi-centre, randomised Phase 3 registrational study. It is comparing BL-M14D1 plus atezolizumab with the current standard of care, consisting of platinum and etoposide induction followed by atezolizumab maintenance, with or without lurbinectedin. The trial is expected to enrol approximately 580 patients, with progression-free survival assessed by blinded independent central review (BICR) serving as the primary endpoint.

SystImmune is developing a pipeline of next-generation ADCs based on its brengitecan platform, which uses a topoisomerase I inhibitor payload designed for targeted delivery to tumour cells. The platform has shown encouraging potential through the clinical progress of izalontamab brengitecan (iza-bren).

BL-M14D1 specifically targets DLL3, a protein that is highly expressed in small cell lung cancer and other neuroendocrine tumours, enabling selective delivery of the therapeutic payload to DLL3-positive cancer cells.

 

Source: prnewswire.com

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