Wide range of research across tumor types underscores Servier’s commitment to discovering novel approaches to addressing difficult-to-treat cancers.
| Wide range of research across tumor types underscores Servier’s commitment to discovering novel approaches to addressing difficult-to-treat cancers Phase 3 AGILE data support recent U.S. Food and Drug Administration approval of TIBSOVO® (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy Updated results of ivosidenib monotherapy to be presented in relapsed/refractory myelodysplastic syndrome (MDS) BOSTON, June 1, 2022 /PRNewswire/ -- Servier a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced that data will be presented from multiple studies across its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, June 3-7 and the European Hematology Association (EHA) 2022 Congress, June 9-12. Data highlighted at ASCO and EHA include multiple company-sponsored and investigator-initiated trials, which underscore the breadth of Servier’s oncology portfolio and commitment to improving outcomes for patients with difficult-to-treat cancers, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), cholangiocarcinoma (CCA), colorectal cancer, pancreatic cancer and lung cancer. At both congresses, new data will be presented from Servier’s phase 3 AGILE study, a global, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO® (ivosidenib tablets) in combination with azacitidine compared with placebo in combination with azacitidine, in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy (≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy). These data build on the efficacy and safety results presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition. Patients with IDH1-mutated AML have a poor prognosis and have fewer treatment options, especially for newly diagnosed patients who are not eligible for intensive chemotherapy. This new AGILE data presentation comes on the heels of the U.S. Food and Drug Administration approval of TIBSOVO in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated AML. Ivosidenib monotherapy has breakthrough therapy designation in IDH1 mutated R/R MDS and Servier will be presenting updated efficacy and safety results at both ASCO and EHA. “Several of the studies being presented at this year’s ASCO and EHA highlight the potential role of IDH inhibition and the company’s overall innovative research portfolio in generating new therapies based on precision approaches,” said David K. Lee, CEO, Servier Pharmaceuticals. “Servier Pharmaceuticals has made immense progress since we’ve launched our oncology program in 2018, and we will continue to move the needle for patients with difficult-to-treat cancers.” In the short time the company has been in the U.S., Servier Pharmaceuticals has established a presence in oncology. The company has tripled its oncology portfolio since 2021 with 21 oncology assets at varying stages of clinical development, and 20 research projects. “Our significant presence at these key congresses demonstrates our long-term commitment to developing innovative therapeutic solutions to meet the needs of patients with difficult-to-treat cancers,” said Claude P. Bertrand, Executive Vice President of Research and Development, Servier Group. “We look forward to presenting to the scientific community data across our diverse portfolio, including research on the potential of IDH inhibition in the treatment of cancers with high unmet needs.” Key highlights of data from Servier and its partners at ASCO are listed below and are available online on the ASCO website: https://conferences.asco.org/am/abstracts. Abstract #7042/Poster #273: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia.
Abstract #7019/Poster #250: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine
Abstract/Publication Only: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine.
Abstract #7053/Poster #284: Ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS): Updated enrollment and results of a phase 1 dose escalation and expansion substudy
Abstract #7005/Oral Presentation: Overall survival by IDH2 mutant allele (R140 or R172) in patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib or conventional care regimens in the phase 3 IDHENTIFY triali
Abstract #7032/Poster #263: Health-related quality of life (HRQoL) with enasidenib vs conventional care regimens in older patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML)i
Abstract #3568/Poster #362: Trifluridine/tipiracil plus bevacizumab (FTD/TPI + BEV) and trifluridine/tipiracil (FTD/TPI) monotherapy in metastatic colorectal cancer (mCRC): results of a meta-analysisii
Abstract/Publication Only: Characterizing Platinum Sensitivity among Medicare FFS Patients with Limited vs Extensive Stage Small Cell Lung Cancer Receiving NCCN® Category 1 Regimensiii
Abstract/Publication Only: Patient Characteristics and Outcomes Associated with Small Cell Lung Cancer by Treatment Status in a U.S. Medicare Populationiii
Abstract/Publication Only: Treatment Patterns and Outcomes Associated with Small Cell Lung Cancer by Platinum Sensitivity Status in a U.S. Medicare Populationiii
Abstract #8584/Poster #210: Trends in Treatment Patterns Associated with Small Cell Lung Cancer in a U.S. Medicare Populationiii
Abstract #7018/Poster #249: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated hematologic malignancies
Abstract #3612/Poster #406: Phase II, multicenter, open-label, non-randomized study of neoadjuvant chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by chemoradiotherapy in patients with rectal cancer in a watch-and-wait program
Abstract #TPS4185/Poster #157b: A randomized phase II study of gemcitabine and nab-paclitaxel compared with 5-fluorouracil, leucovorin, and liposomal irinotecan in older patients with treatment-naïve metastatic pancreatic cancer (GIANT): ECOG-ACRIN EA2186—Trials in progress
Abstract #4005/Oral Presentation: NET-02: A multi-centre, randomised, phase II trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients (pts) with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC)
Servier will be hosting a continuing medical educational program at ASCO focused on hematology:
In addition, encore presentations from ASCO will be presented at EHA: Poster #2209: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia
Poster #2374: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine
Poster #2356: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine
Poster #P765: Updated enrollment and results from the phase 1 substudy of ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS)
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. A privately held company, Servier has the unique freedom to devote its time and energy toward putting those who require our treatment and care first, with future growth driven by innovation in areas of unmet medical need. As a growing leader in oncology, Servier is committed to finding solutions that will address today’s challenges. The company’s oncology portfolio of innovative medicines is 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 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 our 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. More information: www.servier.us About Servier Servier is a global pharmaceutical group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2020, Servier employs 22,500 people worldwide. Servier is an independent group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient’s voice at the heart of its activities. A leader in cardiology, the ambition of the Servier Group is to become a recognized and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology and immuno-inflammatory, and neurodegenerative diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies. More information: www.servier.com Follow us on Social Media: LinkedIn, Twitter Press contacts Servier Group (France and worldwide) Disclosures 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)
Relapsed or Refractory AML
Locally Advanced or Metastatic Cholangiocarcinoma
IMPORTANT SAFETY INFORMATION
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 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, 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
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.
i In partnership with Bristol-Myers Squibb ii In partnership with Taiho Pharmaceutical Co., Ltd iii In partnership with Ipsen Biopharmaceuticals
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