On June 1, 2022 Servier, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that data will be presented from multiple studies across its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, June 9-12 (Press release, Servier, JUN 1, 2022, View Source [SID1234615395]). Data highlighted at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) 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.
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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) (Free ASH Whitepaper) 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 (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).
"Several of the studies being presented at this year’s ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) 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 (Free ASCO Whitepaper) are listed below and are available online on the ASCO (Free ASCO Whitepaper) website: View Source
Abstract #7042/Poster #273: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia.
Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: H. Dohner
Abstract #7019/Poster #250: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine
Date & Time: Saturday, June 4 at 1:15 p.m. CDT; poster will be on display in the poster hall from 8 – 11 a.m.
Poster Discussion: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: S. de Botton
Abstract/Publication Only: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine.
Author: A. Schuh
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
Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: D. Andrew Sallman
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
Date & Time: Tuesday, June 7 at 11:33 a.m. CDT
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: S. de Botton
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
Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C. Dinardo
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
Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Presenting Author: T. Yoshino
Abstract/Publication Only: Characterizing Platinum Sensitivity among Medicare FFS Patients with Limited vs Extensive Stage Small Cell Lung Cancer Receiving NCCN Category 1 Regimensiii
Presenting Author: G. Dieguez
Abstract/Publication Only: Patient Characteristics and Outcomes Associated with Small Cell Lung Cancer by Treatment Status in a U.S. Medicare Populationiii
Presenting Author: P. Cockrum
Abstract/Publication Only: Treatment Patterns and Outcomes Associated with Small Cell Lung Cancer by Platinum Sensitivity Status in a U.S. Medicare Populationiii
Presenting Author: P. Cockrum
Abstract #8584/Poster #210: Trends in Treatment Patterns Associated with Small Cell Lung Cancer in a U.S. Medicare Populationiii
Date & Time: Monday, June 6 at 8 a.m. CDT
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Presenting Author: R. Ramirez
Abstract #7018/Poster #249: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated hematologic malignancies
Date & Time: Saturday, June 4 at 8 a.m. CDT
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C. Lachowiez
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
Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Presenting Author: C. Gregorio Muñoz
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
Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: E. Dotan
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)
Date & Time: Sunday, June 5 at 9 a.m. CDT
Oral Abstract Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: M. McNamara
Servier will be hosting a continuing medical educational program at ASCO (Free ASCO Whitepaper) focused on hematology:
"Advantage with Innovation in AML: Guidance on Developing and Delivering Effective and Highly Personalized Care," administered by PeerView, June 3, 2022
In addition, encore presentations from ASCO (Free ASCO Whitepaper) will be presented at EHA (Free EHA Whitepaper):
Poster #2209: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia
Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: H. Dohner
Poster #2374: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine
Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: A. Schuh
Poster #2356: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine
Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: S. de Botton
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)
Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: C. DiNardo