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).

Approval
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.

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Ivosidenib monotherapy
Ivosidenib monotherapy has breakthrough therapy designation in IDH1 mutated R/R MDS and Servier will be presenting updated efficacy and safety results at ASCO/

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“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.”

Key presentations
Abstract/Poster*Date/TimePresenting Author
#7042/#273Saturday, June 4 at 8 a.m. CDTHartmut 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/#250Saturday, 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 + azacitidineHematologic 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/#284Saturday, June 4 at 8 a.m. CDTDavid 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 substudyHematologic 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 PresentationTuesday, June 7 at 11:33 a.m. CDTStéphane 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 trialHematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
J Clin Oncol 40, 2022 (suppl 16; abstr 7005) | DOI10.1200/JCO.2022.40.16_suppl.7005
#7032/#263Saturday, June 4 at 8 a.m. CDTCourtney 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/#362Saturday, June 4 at 8 a.m. CDTTakayuki 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/#210Monday, June 6 at 8 a.m. CDTRobert A. Ramirez DO, FACP
Trends in Treatment Patterns Associated with Small Cell Lung Cancer in a U.S. Medicare PopulationLung 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/#249Saturday, June 4 at 8 a.m. CDTCurtis Andrew Lachowiez MD

M.D. Anderson Cancer Center, Houston, TX

A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated hematologic malignanciesHematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
J Clin Oncol 40, 2022 (suppl 16; abstr 7018) | DOI10.1200/JCO.2022.40.16_suppl.7018
#3612/#406Saturday, June 4 at 8 a.m. CDTCesar 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 programGastrointestinal Cancer—Colorectal and Anal
J Clin Oncol 40, 2022 (suppl 16; abstr 3612) | DOI10.1200/JCO.2022.40.16_suppl.3612
#TPS4185/#157bSaturday, June 4 at 8 a.m. CDTEfrat 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 progressGastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
J Clin Oncol 40, 2022 (suppl 16; abstr TPS4185)| DOI10.1200/JCO.2022.40.16_suppl.TPS4185
#4005/Oral PresentationSunday, June 5 at 9 a.m. CDTMairead 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

 

Abstract/Publication Only
 
TitleAuthor
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
10.1200/JCO.2022.40.16_suppl.e19024
Characterizing Platinum Sensitivity among Medicare FFS Patients with Limited vs Extensive Stage Small Cell Lung Cancer Receiving NCCN® Category 1 RegimensPaul 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 PopulationRobert 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 PopulationPaul Cockrum

Ipsen, Cambridge, MA

J Clin Oncol 40, 2022 (suppl 16; abstr e20617) | DOI10.1200/JCO.2022.40.16_suppl.e20617

 

Clinical trials
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

Highlights of prescribing information
Ivosidenib tablets (Tibsovo®; Servier) (Prescribing Information)
Azacitidine (Vidaza®; Celgene/Bristol Myers Squibb)(Prescribing Information)

Featured image: ASCO annual meeting 2019. Photo courtesy: © 2019 – 2022 Sunvalley Communication/Evan Wendt. Used with permission.

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