On December 5, 2023 Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that it will present data in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego from December 9-12, 2023 (Press release, Servier, DEC 5, 2023, View Source [SID1234638174]). The latest data underscores Servier’s commitment to advancing scientific research, including gaining a more robust understanding of real-world treatment patterns for patients with difficult and hard-to-treat cancers.

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"ASH is a tremendous opportunity to connect with the broader hematologic community and share scientific advances with the power to improve the treatment landscape for patients in need of innovation," said David K. Lee, CEO, Servier Pharmaceuticals. "On the heels of our recent FDA approval for TIBSOVO (ivosidenib tablets) in relapsed/refractory IDH1-mutated myelodysplastic syndromes (MDS), the fifth FDA approval for Tibsovo across hematology and solid tumors, our data at this year’s ASH (Free ASH Whitepaper) continue to add to Servier’s leadership in mutant IDH inhibition, including additional evidence for Tibsovo + azacitidine as the standard of care for newly diagnosed IDH1-mutated AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy."

Servier data being presented at ASH (Free ASH Whitepaper) are listed below and are available online on the ASH (Free ASH Whitepaper) website here.

A large retrospective study comparing two first-line combination regimens for newly diagnosed patients with IDH1-mutated acute myeloid leukemia (mIDH1 AML), ineligible for intensive chemotherapy, to gain insight into real-world treatment patterns, effectiveness and safety
A global longitudinal study of patients with AML, with or without mIDH1 disease, who received first-line intensive chemotherapy to gain insight into treatment patterns and clinical outcomes in the real-world setting
An analysis of the Phase 3 AGILE study in patients with newly diagnosed AML, who are not eligible for intensive induction chemotherapy, using next-generation sequencing to determine measurable residual disease (MRD), a negative prognostic marker, among patients who had a best overall response to treatment in the study
A retrospective study in adolescents and young adults with acute lymphoblastic leukemia, to gain real-world insight into treatment approaches for this population across diverse cancer care settings
"As we continue to advance our clinical development programs across hematology, we are simultaneously focused on generating real-world evidence data that can help the entire treatment community gather the broadest picture possible to identify the best individualized treatment options," said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "Looking to the future, improving patient outcomes is going to be a collaborative effort across industry, academia and the community. Servier is proud to serve as a bridge across these stakeholders in our goal of improving patient outcomes."

Among Servier data being presented is real-world evidence comparing Tibsovo in combination with hypomethylating agents (HMA) versus venetoclax in combination with hypomethylating agents in patients with newly diagnosed AML (intensive chemotherapy induction ineligible – ICIE ) and a susceptible IDH1 mutation. In the analysis, Tibsovo+HMA elicited a higher complete response (CR) rate versus venetoclax+HMA at 42.9% vs. 26.7% (p=0.007). 6-month event-free survival also favored Tibsovo+HMA at 56.0% vs. 39.6% (p=0.044), as well as 11.5% of patients on Tibsovo+HMA achieving bridge to transplant versus 5.0% on a venetoclax+HMA regimen (p=0.066). The full analysis will be presented on Monday, December 11 at 5:30 p.m. PST.

Additional data being presented at ASH (Free ASH Whitepaper) includes molecular measurable residual disease (MRD) in ICIE patients with newly diagnosed mIDH1 AML treated with Tibsovo+azacitidine, further bolstering the clinical profile of Tibsovo in the front-line setting, as well as real-world analyses examining treatment patterns in both ALL and AML.

Abstract #971 (Oral): A Comparison of Acute Myeloid Leukemia (AML) Regimens: Hypomethylating Agents Combined with Ivosidenib or Venetoclax in Newly Diagnosed Patients with IDH1 Mutations: A Real-World Evidence Study
Date & Time: Monday, December 11, 5:30 p.m.
Lead Author: B. Douglas Smith, M.D., Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Abstract #3816 (Poster): Real-World Treatment Patterns and Clinical Outcomes in Newly Diagnosed Acute Myeloid Leukemia with and without mIDH1 Treated with Intensive Chemotherapy from an International Real-World Database (REAL-IDH)
Date & Time: Sunday, December 10, 6:00 p.m.-8:00 p.m.
Lead Author: Joshua F. Zeidner, The University of North Carolina, Chapel Hill

Abstract #4305 (Poster): Molecular Measurable Residual Disease in Patients with Newly Diagnosed mIDH1 Acute Myeloid Leukemia Treated with Ivosidenib + Azacitidine
Date & Time: Monday, December 11, 6:00 p.m.-8:00 p.m.
Lead Author: Courtney DiNardo, M.D., MSc, The University of Texas MD Anderson Cancer Center, Houston

Abstract #3704 (Poster): Patterns of Care Among Adolescents and Young Adults Treated for Acute Lymphoblastic Leukemia: A Retrospective Study Across Diverse US Practices
Date & Time: Sunday, December 10, 6:00 p.m.-8:00 p.m.
Lead Author: Julie Wolfson, M.D., MSHS, The University of Alabama at Birmingham