Servier to Present Long-Term VORANIGO Data and Novel ADC Results at ASCO 2026
核心洞察
Servier will present updated long-term efficacy and safety data from the Phase 3 INDIGO trial of VORANIGO (vorasidenib) for IDH-mutant glioma (搜索), with over three years of follow-up supporting sustained treatment benefits.
Day One Biopharmaceuticals will share promising Phase 1 results for Emi-Le, a B7-H4 (搜索)-directed ADC showing favorable tolerability and antitumor activity in aggressive adenoid cystic carcinoma (搜索) patients.
The presentations at ASCO 2026 demonstrate Servier's expanding rare oncology portfolio, targeting high unmet medical needs in brain tumors and rare cancers.
Servier announced it will present significant updates on its rare oncology portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 29 - June 2 in Chicago. The presentations will feature long-term data from its approved IDH inhibitor VORANIGO and emerging results from its novel antibody-drug conjugate program.
Long-Term VORANIGO Data Reinforces Durable Benefits
The company will present updated efficacy and safety data from a long-term analysis of the Phase 3 INDIGO trial of VORANIGO (vorasidenib) in a rapid oral presentation on May 31. Key findings from more than three years of follow-up data further support the robust progression-free survival (PFS) and time to next treatment intervention (TTNI) results observed with VORANIGO in previous analyses and confirm the durable and sustained treatment benefit in Grade 2 IDH-mutant glioma (搜索).
Additional exploratory analysis data from the INDIGO trial will demonstrate that long-term treatment with VORANIGO generally led to a sustained decrease in seizure frequency and severity and preservation of quality of life. VORANIGO is currently approved for treating adults and children 12 years of age and older with certain types of brain tumors called astrocytoma (搜索) or oligodendroglioma (搜索) with an IDH1 (搜索) or IDH2 (搜索) mutation, following surgery.
Novel ADC Shows Promise in Rare Cancer
Day One Biopharmaceuticals, now part of Servier Group, will share results from an ongoing Phase 1 trial evaluating investigational compound Emi-Le (emiltatug ledadotin) in an oral presentation on June 1. The data reveal that Emi-Le demonstrates favorable tolerability and promising antitumor activity in patients with aggressive adenoid cystic carcinoma (搜索) (ACC) who have no available treatment options and a poor prognosis.
Emi-Le is a B7-H4 (搜索)-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin-F HPA payload with controlled bystander effect. The U.S. Food and Drug Administration has granted Fast Track designations to Emi-Le for treating adult patients with advanced or metastatic triple-negative breast cancer (搜索) and advanced or metastatic HER2 low/HER2 negative breast cancer post-topo-1 ADC. It has also received Breakthrough Designation from the FDA for treating patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (搜索) with solid histology or high-grade transformation.
Expanding Clinical Development Pipeline
Servier will also feature a placebo-controlled trial of vorasidenib in IDH-mutated newly diagnosed Grade 3 astrocytoma (搜索) led by the Alliance for Clinical Trials in Oncology in a trial in progress presentation. This represents an expansion of the VORANIGO development program into additional glioma subtypes.
"Servier's upcoming presentations at ASCO—which include updated long-term data in IDH-mutant glioma (搜索) as well as emerging data from our newer oncology programs—underscore our dedication to delivering transformative medicines to patients with high unmet needs," said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "Together, these programs demonstrate the continued evolution of Servier's oncology portfolio and our growing presence in rare oncology."
Strategic Focus on Rare Oncology
The presentations reflect Servier's strategic commitment to rare oncology, with the company investing nearly 20% of its brand-name sales in R&D. As an independent international pharmaceutical group governed by a foundation, Servier aims to become a leading innovator in oncology and neurology, offering targeted therapeutic solutions particularly in rare cancers and neurological diseases.
Servier will also present research updates at the European Hematology Association (EHA) 2026 Congress June 11-14 in Stockholm, further demonstrating its commitment to advancing treatments for patients with rare hematologic malignancies.