On October 19, 2026 Servier reported the first patients have been dosed in the pivotal Phase 2 cohort (EMBLEM-1) of a Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in solid tumors. EMBLEM-1 is evaluating the antitumor activity and safety of Emi-Le, an investigational antibody drug conjugate (ADC) directed against B7-H4, in aggressive adenoid cystic carcinoma (ACC).
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"Dosing these first patients marks an important step in advancing Emi-Le as a potential targeted treatment for ACC, a difficult-to-treat cancer with no FDA-approved systemic treatment options," said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "This milestone also underscores the momentum of Servier’s growing oncology portfolio and our commitment to bringing scientific rigor and meaningful innovation to rare cancers where patients face significant unmet need. We look forward to sharing these data with the scientific community."
The primary endpoint is objective response rate (ORR)—defined as the percentage of patients who achieve a best overall response of confirmed complete response (CR) or partial response (PR)— per RECIST 1.1.
The initiation of EMBLEM-1 is supported by clinical data from a Phase 1 analysis of Emi-Le, which demonstrated a differentiated safety profile and were presented in an oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting.
Earlier this year, Emi-Le received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the proposed treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation.
The EMBLEM-1 cohort is currently enrolling (NCT05377996). Additional details regarding the clinical trial can be found here.
(Press release, Servier, OCT 19, 2026, View Source [SID1234673565])