Servier Canada's ^PrVORANIGO™ (vorasidenib tablets) Now Available as First Targeted Treatment for Grade 2 IDH-Mutant Glioma

• First major treatment advance in nearly 25 years
• Gliomas target individuals in the prime of life, often in their 30s and 40s
• Pivotal Phase 3 study shows significant improvement in progression-free survival with a favorable safety profile
• Announcement coincides with National Brain Cancer Awareness Day - October 24, and International Brain Tumour Awareness Week - October 26 to November 2

LAVAL, QC, Oct. 22, 2024 /CNW/ – Servier Canada is pleased to announce the approval and commercial availability of VORANIGO™ (vorasidenib tablets), the first targeted therapy for the treatment of Grade 2 isocitrate dehydrogenase (IDH)-mutant glioma in adults and pediatric patients aged 12 years and older, following surgery. VORANIGO™ offers glioma patients the convenience of a once-daily oral treatment, providing them with an opportunity to actively manage their disease. Canada is the second country after the United States to receive regulatory authorization for VORANIGO™.

About Glioma
Gliomas are the second-most common type of cancer in Canadians under 40 years old and the second-most common cause of cancer-related deaths in this group.¹ These slow-growing brain tumours spread within the brain leading to disruptions in neurological function, seizures, and cognitive impairment. Diffuse gliomas with IDH mutations represent the most common malignant primary brain tumours diagnosed in adults younger than 50 years of age. They are not curable with current therapies and without treatment they continue to grow and infiltrate normal brain tissue. The annual incidence of gliomas is approximately six cases per 100,000 individuals worldwide.²

A key concern with low-grade gliomas is their progression to high-grade gliomas, which are harder to treat and carry a poor prognosis. Research shows that 60-70% of patients with gliomas have the targetable IDH mutation that VORANIGO™ addresses.³

"Patients living with Grade 2 IDH-mutant gliomas must contend with a grim prognosis that has few options outside of surgery. This is a devastating diagnosis, particularly for individuals in their 30s and 40s who are often raising families and at the peak of their careers," said Lucie Rousseau, General Manager of Servier Canada. "Voranigo offers these patients and their families hope. As we continue to develop targeted therapies, identifying specific mutations and understanding their role in cancer progression is critical to ensuring that patients receive the right treatment at the right time. We are proud to be leading the way in IDH-mutant glioma therapy and remain dedicated to supporting the Canadian brain cancer community."

In healthy human cells, a family of enzymes called isocitrate dehydrogenases (IDH) help break down nutrients and generate energy for cells. Mutations in IDH1 and IDH2 genes are associated with a variety of cancers, where they prevent cells from differentiating or specializing into the kind of cells they are ultimately supposed to become. When cells cannot differentiate properly, they may begin to grow out of control.⁴ In IDH-mutant gliomas, VORANIGO™ works by reducing the activity of the mutant IDH1 and IDH2 enzymes, to help control the disease.

Vorasidenib, a dual inhibitor of the mutant IDH1 and IDH2 enzymes, was developed for penetration across the blood–brain barrier.⁵

"This therapy represents a significant advancement in the treatment of Grade 2 IDH-mutant glioma," says Dr. Mary Jane Lim-Fat, neuro-oncologist at Sunnybrook Health Sciences Centre. "Slowing tumour progression and delaying the emergence of high-grade disease are key goals in glioma treatment, and this therapy helps to address those challenges."

Ontario firefighter Steven Stefanidis, who was diagnosed with a Grade 2 IDH-mutant glioma, shared his experience: "My diagnosis came as a complete shock. Here I was in my early 30s, living my best life with a dream job when I suddenly had a seizure. I can't describe what it was like to be told that I had an incurable brain cancer." Steven, who eventually was enrolled in the Voranigo clinical trial at Sunnybrook Health Sciences Centre in Toronto, sums up his prospects for the future this way – "having access to this treatment gives me hope. I've gone back to work and am incredibly grateful."

About the INDIGO Phase 3 Trial (NCT04164901)
VORANIGO's Canadian approval is based on results from the pivotal Phase 3 INDIGO clinical trial which demonstrated a significant improvement in progression-free survival (PFS) and time to next intervention (TTNI) in patients with Grade 2 IDH-mutant glioma compared to placebo. The international Phase 3 clinical trial was led by Dr. Ingo K. Mellinghoff at Memorial Sloan-Kettering Cancer Centre. Results from the trial were published in The New England Journal of Medicine and presented during the Plenary Session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO).

INDIGO, the pivotal Phase 3 clinical trial met its major efficacy outcome of progression free survival (PFS) per a blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis.⁶

Key Findings:

• Median PFS: 27.7 months (VORANIGO™) vs. 11.1 months (placebo)
• VORANIGO™ significantly delayed the need for further treatments.  
• The study showed that VORANIGO™ was well-tolerated, with the most common side effects being increased liver enzymes, fatigue, and diarrhea. These findings are consistent with earlier Phase 1 trials.

About Servier in Oncology
Servier is a global leader in oncology, governed by a non-profit foundation, and is committed to advancing innovation in cancer treatment. The company devotes over 65% of its research and development budget to oncology, with a focus on therapies targeting IDH-mutant cancers. VORANIGO™ is the latest in Servier's portfolio of treatments aimed at IDH-mutant cancers, underscoring its leadership in this crucial therapeutic area.

VORANIGO™ IMPORTANT SAFETY INFORMATION 

Clinical use: 

• No patients <18 years of age were treated with ^PrVoranigo™ in the pivotal phase 3 study. Use of ^PrVoranigo™ in pediatric patients ≥12 years of age is supported by evidence from studies in adults with additional population pharmacokinetic data. The safety and efficacy of Voranigo™ in children <12 years of age have not been established.
• No overall differences in safety or effectiveness were observed for patients aged ≥65 years.

Relevant warnings and precautions: 

• Contains lactose
• Pre-existing severe hepatic impairment
• Renal impairment
• Monitoring complete blood counts and liver laboratory tests
• Fertility
• Pregnant women: may cause fetal harm
• Use of effective non-hormonal contraception in men and women of reproductive potential
• Breast-feeding: Breast-feeding should be discontinued during treatment and for at least 2 months after the last dose.

For more information:

Please consult the Voranigo™ Product Monograph at https://servier.ca/wp-content/uploads/sites/24/2024/08/Product-monograph-VORANIGO.pdf for important information relating to adverse reactions, drug interactions, and dosing adjustments, which have not been discussed in this piece. The Product Monograph is also available by calling Servier Canada at 1-800-363-6093. 

References:

SOURCE Servier Canada