New Data at ASH 2022 Bolster Servier’s Leadership in Hematology Research

-Real-world analysis findings highlight overall survival benefit in adolescent and young adult (AYA) newly-diagnosed acute lymphoblastic leukemia (ALL) patients treated with pediatric-inspired regimens (PIR) versus non-pediatric-inspired regimens  

-Additional data in acute myeloid leukemia (AML) continue to reinforce the potential of IDH mutation inhibitors in the treatment of difficult-to-treat cancers   

 

BOSTON, November 3, 2022 – Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will present new data in acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) at the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10–13, 2022. These latest data add to the growing body of evidence from Servier’s expanding oncology portfolio and underscore its commitment to finding innovative solutions to meet high unmet medical needs.  

The research to be presented includes new insights on Servier’s marketed therapies, including ivosidenib tablets (TIBSOVO®), as well as findings from a real-world analysis comparing overall survival among adolescent and young adults (AYA) with newly-diagnosed acute lymphoblastic leukemia (ALL) treated with pediatric-inspired regimens (including an asparaginase treatment) versus non-pediatric-inspired regimens. 

“While pediatric-inspired regimens containing asparaginase have been the backbone of effective therapy for children and teenagers with most types of acute lymphoblastic leukemia, their use in young adults remains inconsistent across adult centers,” said David R. Freyer, DO, MS, study co-author, Director of Survivorship & Supportive Care at Children’s Hospital Los Angeles, and Co-Director of the AYA Cancer Program at the USC Norris Comprehensive Care Center. “I look forward to presenting our real-world analyses on the potential benefit of pediatric-inspired regimens for young adults with newly-diagnosed acute lymphoblastic leukemia to further our understanding of their impact on survival and survivorship.” 

“Five years after making our strategic commitment to the fight against cancer, the ASH conference allows us to highlight the progress made by the Group, our teams and our partners in developing targeted therapeutic solutions to treat patients with hard-to-treat cancer,” said Claude Bertrand, Executive Vice President Research and Development of the Servier Group. “As a result of innovative and open research, as well as significant and continuous investment, Servier now has 20 oncology projects in clinical development and 17 research projects1 in cancers that meet a strong unmet medical need for patients.” 

Servier abstracts being presented at ASH include: 

Oral Presentation #223: Molecular Characterization of Clinical Response and Relapse in Patients with IDH1m ND-AML Treated with IVO+AZA in the AGILE Study 

  • Date & Time: Saturday, December 10, 2022 at 2:00 pm  

  • Lead Author: Hartmut Döhner 

Oral Presentation #906: Comparison of Overall Survival Among Adolescents and Young Adults (AYA) with Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL) Treated with Pediatric-Inspired or Non-Pediatric Inspired Regimens: A Real-World Analysis Using Claims Data 

  • Date & Time: Monday, December 12, 2022 at 4:00 pm  

  • Lead Author: Tarun Bhagnani  

About Servier Pharmaceuticals 

Servier Pharmaceuticals LLC is a commercial-stage company with a passion for innovation and improving the lives of patients, their families and caregivers. As a privately held company, Servier has the unique freedom to devote all of its time and energy towards patients who require our treatments, care and innovation in areas of unmet medical need. 

As a leader in oncology, Servier is committed to finding solutions that will address today's challenges. The company's oncology portfolio includes innovative medicines designed to bring more life-saving treatments to a greater number of patients, across the entire spectrum of disease and in a variety of tumor types. Servier has significantly accelerated its investment in hard-to-treat cancers with more than 50% of its research and development dedicated to delivering significant advances in areas of high unmet need that may truly move the needle for our patients. 

Servier believes co-creation is fundamental to driving innovation and is actively building alliances, acquisitions, licensing deals and partnerships that bring solutions and accelerate access to therapies. With the company's commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier Pharmaceuticals is dedicated to bringing the promise of tomorrow to the patients that we serve. 

For more information: www.servier.us 

About Servier 

Founded to serve health, Servier is a global group governed by a Foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. With its unique governance model, it can fully serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. The 21,800 employees of the Group are committed to this shared vocation, source of inspiration every day.  

As a world leader in cardiology, Servier's ambition is to become a renowned, focused and innovative player in oncology by targeting hard-to-treat cancers. That is why the Group allocates over 50% of its R&D budget to developing targeted and innovative therapies in oncology.  

Neuroscience and immuno-inflammatory diseases are the future growth drivers. In these areas, Servier is focused on a limited number of diseases in which accurate patient profiling makes it possible to offer a targeted therapeutic response through precision medicine.  

To promote access to quality care for all at a lower cost, the Group also offers a range of quality generic drugs covering most pathologies, relying on strong brands in France, Eastern Europe, Brazil and Nigeria. 

In all these areas, the Group includes the patient voice at each stage of the life cycle of a medicine.  

Headquartered in France, Servier relies on a strong geographical footprint in over 150 countries and achieved a revenue of €4.7 billion in 2021. 

For more information on the new Group website: servier.com 

Press contacts 

Servier Pharmaceuticals (U.S.) 

Julia Ferreira 

julia.ferreira@servier.com 

 

Servier Group (France and worldwide) 

Sonia Marques 

presse@servier.com  

+33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13 

 

Disclosures 
This release contains general information about the Servier Group and its entities (hereinafter "Servier and its Affiliates") and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect. 

Servier and its Affiliates are not acting as an advisor to the recipient of this information, and the ultimate decision to proceed with any transaction rests solely with the recipient of this information. Therefore, prior to entering into any proposed transaction, the recipient of this information should determine, without reliance upon Servier or its Affiliates, the economic risks and merits, as well as the legal, tax, and accounting characterizations and consequences, of the transaction and that it is able to assume these risks. 

This statement also contains forward-looking statements that are subject to varying levels of uncertainty and risk. Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval. They are not approved for use by the FDA. 

Any reliance placed on this document is done entirely at the risk of the person placing such reliance. The information contained in this document is neither an offer to sell nor the solicitation of an offer to enter into a transaction. 

The content of this document is a summary only, is not complete, and does not include all material information about Servier and its Affiliates, including potential conflicts of interest. 

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates disclaim all representations, warranties, conditions and guarantees, whether express, implied, statutory or of other kind, nor does it accept any duty to any person, in connection with this document. Without prejudice to the generality of the foregoing, Servier and its Affiliates do not warrant or represent that the information or opinions contained in this document is accurate or complete. 

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. 

About TIBSOVO (ivosidenib tablets) 

INDICATIONS 

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: 

Newly Diagnosed Acute Myeloid Leukemia (AML) 

  • In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy  

Relapsed or Refractory AML 

  • For the treatment of adult patients with relapsed or refractory AML 

Locally Advanced or Metastatic Cholangiocarcinoma 

  • For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML 
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 multiorgan dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS 

Differentiation Syndrome in AML: In the combination study AG120-C-009, 15% (11/71) of patients with newly diagnosed AML treated with TIBSOVO plus azacitidine experienced differentiation syndrome. 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. Of the 11 patients with newly diagnosed AML who experienced differentiation syndrome with TIBSOVO plus azacitidine, 8 (73%) recovered. Differentiation syndrome occurred as early as 3 days after start of therapy and during the first month on treatment. 

In the monotherapy clinical trial AG120-C-001, 25% (7/28) of patients with newly diagnosed AML and 19% (34/179) of patients with relapsed or refractory AML treated with TIBSOVO experienced differentiation syndrome. Of the 7 patients with newly diagnosed AML who experienced differentiation syndrome, 6 (86%) patients recovered. Of the 34 patients with relapsed or refractory AML who experienced differentiation syndrome, 27 (79%) patients recovered after treatment or after dose interruption of TIBSOVO. Differentiation syndrome occurred as early as 1 day and up to 3 months after TIBSOVO initiation and has been observed with or without concomitant leukocytosis.  

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 antifungals, 5HT3 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, or electrolyte abnormalities, or in 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 

  • In patients with AML, the most common adverse reactions including laboratory abnormalities (≥25%) are leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphate decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, calcium decreased, neutrophils decreased, and myalgia  

  • In patients with cholangiocarcinoma, the most common adverse reactions (≥15%) are fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash. The most common laboratory abnormalities (≥10%) in patients with cholangiocarcinoma are hemoglobin decreased, aspartate aminotransferase increased, and bilirubin increased 

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 

Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with TIBSOVO and for 1 month after the last dose. 

Please see Full Prescribing Information, including BOXED WARNING for AML patients 

Data as of October 2022

*Servier has an exclusive collaboration and license agreement with CStone for the development and commercialization of TIBSOVO (ivosidenib tablets) in Mainland China, Taiwan, Hong Kong, Macau and Singapore.