Boston – October 19, 2026 -- Servier has dosed the first patients in EMBLEM-1, the pivotal Phase 2 cohort of its Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in aggressive adenoid cystic carcinoma (ACC), a cancer with no FDA-approved systemic treatment.
Emi-Le is an investigational antibody drug conjugate (ADC) directed against B7-H4. The cohort is enrolling under trial identifier NCT05377996.
EMBLEM-1 uses objective response rate per RECIST 1.1 as its primary endpoint
The trial will measure the percentage of patients who achieve a best overall response of confirmed complete response or partial response. It will also evaluate the safety of Emi-Le in ACC.
Phase 1 data and FDA Breakthrough Therapy status back the pivotal cohort
Phase 1 results, presented in an oral session at the ASCO 2026 Annual Meeting, showed a differentiated safety profile. Earlier this year, the U.S. Food and Drug Administration granted Emi-Le Breakthrough Therapy Designation for locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation.
Becky Martin, Chief of Medical at Servier Pharmaceuticals, said the first dosing advances Emi-Le as a potential targeted treatment for a difficult-to-treat cancer.
Unmet need in ACC leaves most patients with surgery or radiation
Globally, more than 200,000 people have ACC, which is diagnosed in roughly four per one million people annually. No systemic therapies are approved or preferred for advanced or metastatic disease. Most patients receive surgery or radiation, yet the disease recurs in 50 percent of cases and often becomes more aggressive, with distant metastases.
Emi-Le carries additional FDA Fast Track designations in breast cancer
Emi-Le is a B7-H4-directed Dolasynthen ADC with a drug-to-antibody ratio of 6 and a proprietary auristatin-F HPA payload. The FDA has granted it Fast Track designations for advanced or metastatic triple-negative breast cancer and for advanced or metastatic HER2 low or HER2 negative breast cancer after topo-1 ADC therapy. The drug has not been approved by the FDA, and its safety and effectiveness have not been established.