• Positive Phase 1 data were previously presented in an oral session at ASCO 2026
• 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

BOSTON, Oct. 19, 2026 /PRNewswire/ — Servier today announced 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).

“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) 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.

Media contact 
Darby Malkin: darby.malkin@servier.com 

About Emi-Le
Emi-Le is an investigational B7-H4-directed Dolasynthen antibody drug conjugate (ADC) with a drug-to-antibody ratio (DAR) of 6 and a proprietary auristatin-F HPA payload designed to provide a controlled bystander effect as demonstrated in preclinical models. Emi-Le is under evaluation in an ongoing Phase 1/2 clinical trial and has not been approved by the FDA, and its safety and effectiveness have not been established. The U.S. Food and Drug Administration has granted Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic HER2 low / HER2 negative breast cancer post-topo-1 ADC (including TNBC and certain HR+ breast cancers). It has also received Breakthrough Designation from the FDA for the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma with solid histology or high-grade transformation. For more information about the trial, visit clinicaltrials.gov (NCT05377996).

About Adenoid Cystic Carcinoma
Adenoid cystic carcinoma (ACC) occurs in the secretory glands, typically in the head and neck, but also in other areas of the body. Globally, more than 200,000 people have ACC. It is diagnosed in roughly four per one million people annually and does not discriminate by ethnicity or lifestyle factors. Today there are no approved or preferred systemic therapies to treat advanced or metastatic ACC; most people are treated with surgery or radiation, but the disease recurs in 50 percent of cases, often becoming more aggressive with metastases in distant areas of the body.¹

About Servier in Oncology
Servier is a global leader in oncology, governed by a non-profit foundation. Servier approaches innovation with a long-term vision, free of influence from fiduciary responsibilities. 

Servier invests close to 20% of revenue from brand-name medicines in R&D each year. Servier aspires to advance more targeted therapies by identifying mutations and understanding how these mutations impact cancer and its progression. Servier believes we can serve more people by helping the right patients find the right treatment, at the right time.

Servier takes a One Innovation Engine approach to R&D and is actively seeking alliances, partnerships and acquisitions at various stages of the portfolio.

For more information about working with Servier to bring the promise of tomorrow to the patients it serves, visit Servier.com and Servier.us.

Disclosures
This release contains general information about the Servier Group and its entities (hereinafter “Servier and its Affiliates”) and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect.

Servier and its Affiliates are not acting as an advisor to the recipient of this information, and the ultimate decision to proceed with any transaction rests solely with the recipient of this information. Therefore, prior to entering into any proposed transaction, the recipient of this information should determine, without reliance upon Servier or its Affiliates, the economic risks and merits, as well as the legal, tax, and accounting characterizations and consequences, of the transaction and that it is able to assume these risks.

This statement also contains forward-looking statements that are subject to varying levels of uncertainty and risk. Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval. They are not approved for use by the FDA.

Any reliance placed on this document is done entirely at the risk of the person placing such reliance. The information contained in this document is neither an offer to sell nor the solicitation of an offer to enter into a transaction.

The content of this document is a summary only, is not complete, and does not include all material information about Servier and its Affiliates, including potential conflicts of interest.

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates disclaim all representations, warranties, conditions and guarantees, whether express, implied, statutory or of other kind, nor does it accept any duty to any person, in connection with this document. Without prejudice to the generality of the foregoing, Servier and its Affiliates do not warrant or represent that the information or opinions contained in this document is accurate or complete.

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates shall not be liable for any loss, damage or expense whatsoever, whether direct or indirect, howsoever arising, whether in contract, tort (including negligence), strict liability or otherwise, for direct, indirect, incidental, consequential, punitive or special damages arising out of or in connection with this document, including (without limitation) any course of action taken on the basis of the same. The estimates, strategies, and views expressed in this document are based upon past or current data and information and are subject to change without notice.

References

¹ Adenoid Cystic Carcinoma Research Foundation. Accessed May 2026.

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