On December 9, 2023 Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve,reported that it will be presenting new data in acute myeloid leukemia (AML) at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Servier, DEC 9, 2023, View Source [SID1234638342]). These data provide a compelling and in-depth look into the treatment patterns and clinical outcomes observed in real-world settings, offering valuable insights for informed decision-making in patient care.

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"During our initial five years in the oncology space, Servier has more than doubled its portfolio and launched several new indications for TIBSOVO in IDH1-mutant cancers, including frontline AML, myelodysplastic syndromes (MDS) and previously treated cholangiocarcinoma (CCA) – many of these indications serving as a best-in-class treatment option," said Arjun Prasad," Head of Commercial, Servier Pharmaceuticals. "As the leader driving the science behind targeted mutant IDH inhibition, we strive to maximize the benefits of molecular testing to improve patient outcomes and continue to focus on areas of unmet need where patients could benefit from personalized medicine, from our multiple approvals across hematology and solid tumors to ongoing research in difficult to treat and rare cancers such as chondrosarcoma."

More information on testing for IDH mutations in cancer can be found at IDHlearnmore.com.

Data being presented at ASH (Free ASH Whitepaper) include real-world evidence analysis in patients with newly diagnosed AML (intensive chemotherapy induction ineligible (ICIE) and a susceptible IDH1 mutation comparing Tibsovo in combination with hypomethylating agents (HMA) versus venetoclax in combination with hypomethylating agents. In the analysis of 238 patients, 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). Median time from diagnosis to start of treatment was 14 versus 20 days for Tibsovo+HMA vs venetoclax+HMA. Treatment discontinuation was 37% for both regimens and toxicity incidence was similar, with the exception of higher febrile neutropenia (FN) rates for venetoclax+HMA versus Tibsovo+HMA (7.9% vs. 1.6%; p=0.009). Patients receiving Tibsovo+HMA had a 61% lower relative risk of unscheduled acute care use in the first 12 weeks (42.9% versus 70.3% for venetoclax+HMA; p<0.001). Venetoclax schedule intensity was also captured, with only 22.8% receiving the full FDA-labeled 28 days of venetoclax during the 28-day cycles; 44.6% did not receive >11 days of venetoclax per cycle. The full analysis will be presented on Monday, December 11 at 4:30 p.m. PST.

"At Servier, we bring the patient voice into everything we do, and our commitment to patients extends far beyond approval," emphasized Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "As a privately held company, we have the ability to invest in the long-term in ways that help to create better understandings on the real-world impact our medicines have on the lives of patients. We’re proud to once again present real-world evidence at ASH (Free ASH Whitepaper), offering the broader oncology community insights into treatment patterns that can help in the development of the best possible treatment regimen for each individual patient."

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.