First patient enrolled in the Phase 3 CHONQUER clinical trial in patients with IDH1-mutant conventional chondrosarcoma
Phase 3 PyramIDH clinical trial in patients with IDH1-mutant myelodysplastic syndromes has been initiated with sites actively recruiting across the world
BOSTON, Jan. 9, 2025 /PRNewswire/ -- Servier today announced updates to two of its Phase 3 programs evaluating TIBSOVO (ivosidenib tablets) in isocitrate dehydrogenase 1 (IDH1)-mutated cancers. The first patient has been enrolled in the CHONQUER study, a pivotal Phase 3 clinical trial evaluating the efficacy and safety of TIBSOVO versus placebo in patients with IDH1-mutated conventional chondrosarcoma. In addition, the Phase 3 PyramIDH clinical trial has been initiated, and sites are actively recruiting across the globe. The PyramIDH study is evaluating TIBSOVO® (ivosidenib tablets) monotherapy and azacitidine monotherapy in the treatment of patients with IDH1-mutated myelodysplastic syndromes (MDS) who have not previously been treated with a hypomethylating agent.
"As the leader in IDH-mutated cancers, Servier aspires to provide new treatment options for those impacted by newly diagnosed IDH1-mutated conventional chondrosarcoma and IDH-1 mutated MDS. The advancement of two of our Phase 3 registration enabling studies is an incredibly important milestone for our TIBSOVO clinical development program and underscores our commitment to understanding the application of IDH1m inhibition in a broad range of malignancies to meet the needs of patients," said Susan Pandya, MD, Vice President, Clinical Development and Global Head of Oncology LS/LCM, Servier Pharmaceuticals. "We are deeply grateful to the patients, families and healthcare providers who are participating in this important research."
The use of TIBSOVO in patients with IDH1-mutated conventional chondrosarcoma, as well as, patients with IDH1-mutated myelodysplastic syndromes who have not previously been treated with a hypomethylating agent are investigational, and its safety and efficacy in these cases have not been evaluated by any regulatory authority.
About the PyramIDH Trial (NCT06465953)
PyramIDH is a pivotal Phase 3, multicenter, open label, randomized clinical trial of TIBSOVO (ivosidenib tablets) monotherapy and azacitidine monotherapy in adult patients with myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. The primary endpoint of PyramIDH is complete remission (CR) or partial remission (PR) as per International Working Group (IWG) 2006 criteria at 4 months. Secondary outcome measures include overall response (OR) rate, event-free survival (EFS) and overall survival (OS).
About the CHONQUER Trial (NCT06127407)
CHONQUER is a pivotal Phase 3, multicenter, double-blind, randomized, placebo-controlled crossover clinical trial of TIBSOVO (ivosidenib tablets) in adult patients with locally advanced or metastatic conventional chondrosarcoma with an isocitrate dehydrogenase protein, 1 (IDH1) mutation who are untreated or were previously treated with one systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint of CHONQUER is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary outcome measures include endpoints such as PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. The study also will evaluate the impact of TIBSOVO on health-related quality of life (HRQoL) and health economic outcomes.
About TIBSOVO® (ivosidenib tablets)
TIBSOVO is a precision medicine that targets a specific type of mutation known as isocitrate dehydrogenase 1 (IDH1). TIBSOVO is approved in five indications globally, including approvals in the U.S., European Union, Australia and China.
In the U.S., TIBSOVO is approved for the treatment of adults with IDH1-mutant relapsed or refractory AML and in monotherapy or in combination with azacitidine for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy, as monotherapy for the treatment of adult patients with IDH1-mutant relapsed or refractory MDS, and for patients with previously treated IDH1-mutated cholangiocarcinoma.
For more information about TIBSOVO in the U.S., please visit www.tibsovo.com.
About Myelodysplastic Syndromes
Myelodysplastic Syndromes (MDS) are disorders in which progenitor (stem) cells do not mature into healthy blood cells.1 In the U.S., approximately 16,000 new cases of MDS are reported each year.2 Approximately 3.6% of MDS patients have an IDH1 mutation,3 which is considered an early "driver" mutation.4 For MDS patients with an IDH1 mutation, the prognosis has often been associated with worse overall outcomes and in an increased risk of transformation to AML.3 Prior to the approval of TIBSOVO, there were no approved targeted therapies for this molecularly defined subset.
About Chondrosarcoma
Chondrosarcoma is a group of bone tumors that are made up of cells that make too much cartilage.1 Chondrosarcoma, the second most common sarcoma of the bones following osteosarcoma,5 accounts for 20-30% of all skeletal sarcomas and has an estimated incidence of 1 in 200,000 per year in the U.S.6 Conventional primary chondrosarcoma is the most common variant and makes up 85% of all cases.2 IDH mutations are found in 50-70% of chondrosarcomas.7 Surgery currently remains the mainstay of treatment for conventional chondrosarcoma as both radiation and chemotherapy have been shown to be ineffective.8
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 is the leader in IDH-mutant targeted therapies and devotes more than 65% of its research and development budget to Oncology. 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.us.
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Sara Noonan
1 Pagliuca S, Gurnari C, Visconte V. Molecular Targeted Therapy in Myelodysplastic Syndromes: New Options for Tailored Treatments. Cancers. 2021;13(4):784. https://doi.org/10.3390/cancers13040784.
2 SEER MDS Incidence Rates. Available at: https://seer.cancer.gov/statistics-network/explorer/application.html?site=409&data_type=1&graph_type=2&compareBy=age_range&chk_age_range_1=1&chk_age_range_16=16&chk_age_range_62=
&advopt_precision=1&advopt_show_ci=on&hdn_view=1&advopt_show_apc=on&advopt_display=1; U.S. Census Bureau Population Estimates 2017 National Population Projections Tables: Main Series (census.gov). https://www.census.gov/data/tables/2017/demo/popproj/2017-summary-tables.html. Accessed December 5, 2024.
3 Thol F, Weissinger EM, Krauter J, et al. IDH1 mutations in patients with myelodysplastic syndromes are associated with an unfavorable prognosis. Haematologica. 2010;95(10)1668-1674. https://doi.org/10.3324/haematol.2010.025494. Accessed December 5, 2024.
4 DiNardo CD, Jabbour E, Ravandi F, et al. IDH1 and IDH2 mutations in myelodysplastic syndromes and role in disease progression. Leukemia. 2016;30(4):980-4. http://doi.org/10.1038/leu.2015.211. Accessed December 5, 2024.
5 Anfinsen KP, Devesa SS, Bray F, et al. Age-Period-Cohort Analysis of Primary Bone Cancer Incidence Rates in the United States (1976–2005) Cancer Epidemiol. Prev. Biomark. 2011;20:1770-1777. https://doi.org/10.1158/1055-9965.EPI-11-0136. Accessed December 5, 2024.
6 Giuffrida AY, Burgueno JE, Koniaris LG, et al. Chondrosarcoma in the United States (1973 to 2003): An Analysis of 2890 Cases from the SEER Database. JBJS. 2009;91:1063-1072. https://doi.org/10.2106/JBJS.H.00416. Accessed December 5, 2024.
7 Amary MF, Bacsi K, Maggiani F, et al. IDH1 and IDH2 Mutations Are Frequent Events in Central Chondrosarcoma and Central and Periosteal Chondromas but Not in Other Mesenchymal Tumours. J. Pathol. 2011;224:334-343. https://doi.org/10.1002/path.2913. Accessed December 5, 2024.
8 Polychronidou G, Karavasilis V, Pollack SM, et al. Novel Therapeutic Approaches in Chondrosarcoma. Future Oncol. 2017;13:637-648. https://doi.org/10.2217/fon-2016-0226. Accessed December 5, 2024.
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