#USA #Boston #Servier Pharmaceuticals #VORANIGO #glioma treatment

Servier Releases Promising Long-Term Data on VORANIGO

Servier Pharmaceuticals has announced groundbreaking results from the extended analysis of the Phase 3 INDIGO trial, assessing the efficacy of VORANIGO (vorasidenib) in patients diagnosed with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (mIDH1/2) glioma. The latest findings were recently published in The Lancet Oncology, marking a significant milestone for this innovative treatment in neuro-oncology.

The INDIGO trial, designed as a randomized, double-blind, placebo-controlled study, focuses on patients who have undergone surgical intervention for glioma and for whom chemoradiotherapy can be postponed. With data collected over a median follow-up period of 20.1 months, Servier's analysis revealed compelling outcomes that affirm the drug's therapeutic value in managing glioma.

Key Findings from the INDIGO Trial

According to the new data, VORANIGO demonstrated a notable improvement in median progression-free survival (PFS), with rates significantly outperforming that of the placebo. The latest estimates indicate a PFS that is not currently estimable for VORANIGO, in contrast to 11.4 months for placebo, resulting in a hazard ratio of 0.35, which suggests a considerable advantage for VORANIGO (p < 0.0001).

Imaging assessments further revealed that only 32% of patients receiving VORANIGO experienced disease progression compared to 64% on placebo, underscoring the drug's potential to effectively manage tumor growth.

Moreover, the analysis also indicated enhancements in the median time to next intervention (TTNI), where VORANIGO patients exhibited a reduced intervention time (not estimable for VORANIGO compared to 20.1 months for placebo), reflecting durable disease management (HR, 0.25; p < 0.0001).

Efficacy and Safety Profile

Patients treated with VORANIGO reported not only lower tumor growth rates but also a reduction in seizure frequency, with rates of seizures per person-year significantly lower for those on VORANIGO (18.2 seizures) versus those receiving placebo (51.2 seizures; p = 0.026). Importantly, the treatment did not adversely impact health-related quality of life or neurocognitive function for the patients involved.

Servier's ongoing commitment to safety was also highlighted, with serious treatment-emergent adverse events (TEAEs) consistent with earlier data. The most commonly reported adverse events included increased liver enzyme levels and seizures, yet no new safety concerns were identified and treatment discontinuation due to adverse events remained below 5%.

Significance of the Findings

These results are especially crucial considering the historical lack of effective treatments for patients with Grade 2 IDH-mutated gliomas, where options have remained limited for decades. This innovative therapy provides hope, fundamentally altering the growth dynamics of gliomas that have resisted traditional treatments. Dr. Timothy Cloughesy, a leading investigator in the INDIGO trial, emphasized the transformative potential of targeted IDH inhibition in the management of gliomas.

VORANIGO, which gained FDA approval in August 2024 as the first targeted treatment for this patient demographic, has already been a boon for many, providing lasting therapeutic effects supported by extensive clinical research.

Ongoing Research

The Phase 3 INDIGO trial continues to evolve, with Servier preparing to share even more extensive long-term follow-up data involving the largest patient dataset related to IDH-mutant gliomas. By advancing our understanding of targeted therapies, Servier is determined to enhance treatment outcomes for individuals facing these complex brain tumors.

As research continues, the spotlight will remain on VORANIGO and its potential to reshape the landscape of glioma treatment through innovative, science-backed strategies.

• ---

For more information about VORANIGO and the INDIGO trial, you may visit Servier Pharmaceutials.