Data in acute myeloid leukemia shows clinical benefits of TIBSOVO®+azacitidine as the standard of care in front-line IDH1-mutated AML
Data in acute lymphoblastic leukemia furthers Servier’s commitment to patients with ALL across pediatric, adolescent/young adult and adult populations
BOSTON, December 5, 2023 –Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will present data in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12, 2023. The latest data underscores Servier’s commitment to uncover insights that can lead to improved outcomes for patients through advancing scientific research and analyzing real-world evidence for patients with difficult and hard-to-treat cancers.
“On the heels of our recent FDA approval for TIBSOVO® (ivosidenib tablets) in relapsed/refractory IDH1-mutated myelodysplastic syndromes (MDS), we are coming to ASH with another proof point on our industry leadership in mutant IDH inhibition and bringing transformational treatments to people faced with high unmet needs in oncology, including blood cancers,” said David K. Lee, CEO, Servier Pharmaceuticals. “Through our focus on precision medicine, we are also advocates of molecular testing. As turn-around times get faster, and data shows that waiting to treat in some patient populations until molecular profiling is complete does not result in a negative prognostic outcome, we hope to provide comprehensive and meaningful treatment information that may help to improve outcomes.”
More information on testing for IDH mutations in cancer can be found at IDHlearnmore.com.
Servier data being presented at ASH are listed below and are available online on the ASH website here.
“Looking to the future, improving patient outcomes is going to be a collaborative effort across the industry, academia and the community. Servier is proud to serve as a bridge across these stakeholders in our goal of improving patient outcomes,” said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. “By delving deeper into data and experiences, we can identify key factors that, when addressed, contribute to a more effective and tailored healthcare strategy, ultimately benefiting the patients we serve.”
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 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
About Servier in Oncology
Servier is a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves. Governed by a non-profit foundation, Servier approaches innovation with a long-term vision, free of influence from investors and outside pressure to chase short-term monetary targets.
As a leader in oncology, Servier has significantly accelerated its investment in difficult and hard-to-treat cancers, with more than 50% of its research and development dedicated to delivering significant advances in areas of high unmet need throughout oncology with the potential to change the lives of the patients it serves. Within these areas, Servier is the leader in mutant IDH inhibition, with the first ever mutant IDH1 inhibitor approved in the U.S. and the European Union, and the company continues to drive the science behind targeted mutant IDH inhibition.
Servier’s commitment to therapeutic progress guides its collaboration strategy. While many companies across the industry are scaling back investments, Servier is actively building alliances, completing acquisitions, conducting licensing deals and entering new partnerships that can help to accelerate access to therapies for patients in need. With the company’s commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier is dedicated to bringing the promise of tomorrow to the patients it serves.
Press Contact
Servier Pharmaceuticals
Nathan Mellor
nathan.mellor@servier.com
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To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates shall not be liable for any loss, damage or expense whatsoever, whether direct or indirect, howsoever arising, whether in contract, tort (including negligence), strict liability or otherwise, for direct, indirect, incidental, consequential, punitive or special damages arising out of or in connection with this document, including (without limitation) any course of action taken on the basis of the same. The estimates, strategies, and views expressed in this document are based upon past or current data and information and are subject to change without notice.
TIBSOVO IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS
INDICATIONS
TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test with:
Newly Diagnosed Acute Myeloid Leukemia (AML)
Relapsed or Refractory AML
Relapsed or Refractory Myelodysplastic Syndromes (MDS)
Locally Advanced or Metastatic Cholangiocarcinoma
IMPORTANT SAFETY INFORMATION
| WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. |
WARNINGS AND PRECAUTIONS
Differentiation Syndrome in AML and MDS: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal.
Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome and creatinine increased.
If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe.
QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary.
Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.
Guillain-Barré Syndrome: Guillain-Barré syndrome can develop in patients treated with TIBSOVO. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome.
ADVERSE REACTIONS
DRUG INTERACTIONS
Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation.
Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO.
Sensitive CYP3A4 substrates: Avoid concomitant use with TIBSOVO.
QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation.
LACTATION:
Advise women not to breastfeed.
Please see Full Prescribing Information, including BOXED WARNING for AML and MDS patients.