During the upcoming 2022 annual meeting of the American Society of Clinical Oncology (ASCO) to be held June 3 – 7, 2022, French pharmaceutical company Servier will be presenting results from multiple studies across its oncology portfolio.
The highlighted data will include results from multiple company-sponsored and investigator-initiated trials, underscoring 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.
The presentations include results from the phase 3 AGILE study, a global, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of ivosidenib tablets (Tibsovo®), a potent oral targeted inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1), in combination with the demethylation agent azacitidine (Vidaza®; Celgene/Bristol Myers Squibb), 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 ivosidenib tablets 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 ASCO/
“Several of the studies being presented at this year’s ASCO highlight the potential role of IDH inhibition and the company’s overall innovative research portfolio in generating new therapies based on precision approaches,” explained 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,”Lee added.
Building an oncology portfolio
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.”
|#7042/#273||Saturday, June 4 at 8 a.m. CDT||Hartmut Dohner MD|
|Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia.||Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant|
|J Clin Oncol 40, 2022 (suppl 16; abstr 7042) | DOI 10.1200/JCO.2022.40.16_suppl.7042|
|#7019/#250||Saturday, June 4 at 1:15 p.m. CDT (The poster will be on display in the poster hall from 8 – 11 a.m)||Stéphane De Botton|
Institut Gustave Roussy, Villejuif, France
|Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine||Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant|
J Clin Oncol 40, 2022 (suppl 16; abstr 7019) | DOI 10.1200/JCO.2022.40.16_suppl.7019
|#7053/#284||Saturday, June 4 at 8 a.m. CDT||David Andrew Sallman MD|
|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||Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant|
|J Clin Oncol 40, 2022 (suppl 16; abstr 7053) | DOI10.1200/JCO.2022.40.16_suppl.7053|
|#7005/Oral Presentation||Tuesday, June 7 at 11:33 a.m. CDT||Stéphane De Botton|
Institut Gustave Roussy, Villejuif, France
|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 trial||Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant|
|J Clin Oncol 40, 2022 (suppl 16; abstr 7005) | DOI10.1200/JCO.2022.40.16_suppl.7005|
|#7032/#263||Saturday, June 4 at 8 a.m. CDT||Courtney Denton Dinardo MD|
The University of Texas MD Anderson Cancer Center, Houston, TX
|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)||Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant|
|J Clin Oncol 40, 2022 (suppl 16; abstr 7032) | DOI10.1200/JCO.2022.40.16_suppl.7032|
|#3568/#362||Saturday, June 4 at 8 a.m. CDT||Takayuki Yoshino, MD, Ph.D.|
|Trifluridine/tipiracil plus bevacizumab (FTD/TPI + BEV) and trifluridine/tipiracil (FTD/TPI) monotherapy in metastatic colorectal cancer (mCRC): results of a meta-analysis.||Gastrointestinal Cancer—Colorectal and Anal Cancer|
|J Clin Oncol 40, 2022 (suppl 16; abstr 3568) | DOI</span10.1200/JCO.2022.40.16_suppl.3568|
|#8584/#210||Monday, June 6 at 8 a.m. CDT||Robert A. Ramirez DO, FACP|
|Trends in Treatment Patterns Associated with Small Cell Lung Cancer in a U.S. Medicare Population||Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers|
|J Clin Oncol 40, 2022 (suppl 16; abstr 8584) | DOI10.1200/JCO.2022.40.16_suppl.8584|
|#7018/#249||Saturday, June 4 at 8 a.m. CDT||Curtis Andrew Lachowiez MD|
M.D. Anderson Cancer Center, Houston, TX
|A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated hematologic malignancies||Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant|
|J Clin Oncol 40, 2022 (suppl 16; abstr 7018) | DOI10.1200/JCO.2022.40.16_suppl.7018|
|#3612/#406||Saturday, June 4 at 8 a.m. CDT||Cesar Gregorio Muñoz|
MDHM-CIOCC, Madrid, Spain
|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||Gastrointestinal Cancer—Colorectal and Anal|
|J Clin Oncol 40, 2022 (suppl 16; abstr 3612) | DOI10.1200/JCO.2022.40.16_suppl.3612|
|#TPS4185/#157b||Saturday, June 4 at 8 a.m. CDT||Efrat Dotan MD|
Fox Chase Cancer Center, Philadelphia, PA
|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||Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary|
|J Clin Oncol 40, 2022 (suppl 16; abstr TPS4185)| DOI10.1200/JCO.2022.40.16_suppl.TPS4185|
|#4005/Oral Presentation||Sunday, June 5 at 9 a.m. CDT||Mairead Geraldine McNamara PhD, MBBCh, BSc|
University of Manchester, Manchester, United Kingdom
|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)||Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary|
|J Clin Oncol 40, 2022 (suppl 16; abstr 4005) | DOI10.1200/JCO.2022.40.16_suppl.4005|
|Note: * All abstracts are available on the ASCO 2022 conference website #ASCO22|
|Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine.||Andre Claudius Schuh MD|
Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada
|J Clin Oncol 40, 2022 (suppl 16; abstr e19024) | DOI|
|Characterizing Platinum Sensitivity among Medicare FFS Patients with Limited vs Extensive Stage Small Cell Lung Cancer Receiving NCCN® Category 1 Regimens||Paul Cockrum|
Ipsen, Cambridge, MA
|J Clin Oncol 40, 2022 (suppl 16; abstr e20601) | DOI10.1200/JCO.2022.40.16_suppl.e20601|
|Patient Characteristics and Outcomes Associated with Small Cell Lung Cancer by Treatment Status in a U.S. Medicare Population||Robert A. Ramirez DO, FACP|
Vanderbilt University Medical Center, Nashville, TN
|J Clin Oncol 40, 2022 (suppl 16; abstr e20614) | DOI10.1200/JCO.2022.40.16_suppl.e20614|
|Treatment Patterns and Outcomes Associated with Small Cell Lung Cancer by Platinum Sensitivity Status in a U.S. Medicare Population||Paul Cockrum|
Ipsen, Cambridge, MA
|J Clin Oncol 40, 2022 (suppl 16; abstr e20617) | DOI10.1200/JCO.2022.40.16_suppl.e20617|
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE) – NCT03173248
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation – NCT02074839
An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation (IDHENTIFY) – NCT02577406
Featured image: ASCO annual meeting 2019. Photo courtesy: © 2019 – 2022 Sunvalley Communication/Evan Wendt. Used with permission.