Servier’s $1.8 billion oncology bet has delivered a phase 3 win. Vorasidenib, a candidate covered by the French drugmaker’s buyout of Agios Pharmaceuticals’ cancer unit, beat placebo on the primary endpoint at an interim analysis to bring forward Servier’s regulatory filing plans.
Buying Agios’ oncology business added two approved drugs, Idhifa and Tibsovo, to Servier’s portfolio and a clutch of clinical-phase candidates to its pipeline. Vorasidenib, a dual inhibitor of mutant IDH1/2, was the jewel of the acquired pipeline, as reflected in the $200 million milestone payment that is tied to its approval in the U.S.
That jewel is shining a little brighter today. Servier put out news Tuesday morning that vorasidenib improved progression-free survival in patients with residual or recurrent IDH mutant low-grade glioma, a form of malignant brain tumor, causing the phase 3 trial to hit its primary endpoint. Vorasidenib also beat placebo on the key secondary endpoint of time to next intervention.
In a statement, Susan Pandya, M.D., vice president of clinical development and head of cancer metabolism global development oncology and immuno-oncology at Servier, said the data present “an opportunity to shift the treatment paradigm for patients with IDH mutant low-grade glioma by potentially delivering the first targeted therapy.”
Low-grade gliomas are incurable and ultimately progress to high-grade disease. Treatment options are limited, though. After surgery, physicians typically take a wait-and-watch approach with patients at lower risk of disease progression and administer postoperative chemo-radiotherapy to higher-risk patients.
The fact that IDH mutations occur in 70% of patients and promote tumor formation suggested there may be a better way to treat the disease. Servier, building on the work of Agios, now has evidence to support that suggestion.
With the phase 3 hitting at the interim analysis and enrollment taking less time than expected, Servier is well ahead of schedule. The drugmaker is still determining the timelines for filing for approval and for adapting vorasidenib supply capacity but looks set to meet the deadline for the $200 million milestone. Agios needs Servier to win FDA approval by the start of 2027 to trigger the payment.