On November 5, 2021 Servier, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported new data in acute myeloid leukemia (AML) to be presented at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) taking place December 11 – 14, 2021 (Press release, Servier, NOV 5, 2021, View Source [SID1234594616]).
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"Our growing oncology portfolio is designed to tackle hard-to-treat cancers and deliver new therapies for patients in need," said David K. Lee, Chief Executive Officer of Servier Pharmaceuticals. "At this year’s ASH (Free ASH Whitepaper) meeting, we are proud to present new data demonstrating significant clinical outcomes for patients living with AML."
"We look forward to sharing our findings with the medical community around the world, leveraging our leadership in oncology to strengthen our commitment to patients with hematological malignancies," said Claude Bertrand, Executive Vice President, R&D, Servier Group.
Servier abstracts being presented at ASH (Free ASH Whitepaper) include:
Abstract Title
Lead Author
Presentation Type/#
Session Title
Session Date/Time
Acute Myeloid Leukemia
AGILE: A Global, Randomized, Double-Blind, Phase 3 Study
of Ivosidenib + Azacitidine Versus Placebo + Azacitidine in
Patients with Newly Diagnosed Acute Myeloid Leukemia
Pau Montesinos, M.D., Ph.D., et. al.
Oral
Abstract #697
616. Acute Myeloid Leukemias:
Investigational Therapies, Excluding
Transplantation and Cellular
Immunotherapies: Targeted Therapies
and Novel Therapies
Monday, December 13 at 2:45 pm ET
Updated Survival and Response Analyses from a Phase 1
Study of Ivosidenib or Enasidenib Combined with Induction
and Consolidation Chemotherapy in Patients with Newly
Diagnosed AML with an IDH1 or IDH2 Mutation
Eytan M. Stein, M.D, et. al.
Poster
Abstract #1276
616. Acute Myeloid Leukemias:
Investigational Therapies,
Excluding Transplantation and Cellular
Immunotherapies: Poster I
Saturday, December 11 at 5:30 pm ET
Acute Lymphoblastic Leukemia
Safety and Pharmacokinetics of Calaspargase Pegol in
Adults with Newly Diagnosed Philadelphia-Negative ALL: A Phase
2/3 Study
Wendy Stock, M.D., et. al.
Abstract Only
N/A
N/A
About NCT03173248 AGILE Phase 3 AML Trial
The AGILE trial is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO in combination with azacitidine compared with placebo in combination with azacitidine, in patients with newly diagnosed IDH1 mutant AML who are not candidates for intensive chemotherapy. The study’s primary endpoint is EFS, defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure is defined as failure to achieve complete remission (CR) by Week 24.
Other key secondary endpoints included complete remission rate (CR rate), defined as the proportion of participants who achieve a CR; overall survival (OS), defined as the time from date of randomization to the date of death due to any cause; CR and complete remission with partial hematologic recovery (CRh) rate, defined as the proportion of participants who achieve a CR or CRh; and objective response rate (ORR), defined as the rate of CR, CR with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery [CRp]), partial remission (PR), and morphologic leukemia-free state (MLFS).
About NCT02632708 Phase 1 AML Trial
The NCT02632708 is a U.S., Phase 1 multicenter, clinical trial designed to evaluate the safety of ivosidenib (AG-120) or enasidenib (AG-221) when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate up to 2 dose levels of AG-120 in participants with an isocitrate dehydrogenase protein 1 (IDH1) mutation and up to 2 dose levels of AG-221 in participants with an isocitrate dehydrogenase protein 2 (IDH2) mutation. AG-120 or AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide [ME] or cytarabine). After consolidation therapy, participants may continue on to maintenance therapy and receive daily treatment with single-agent AG-120 or AG-221 until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT). The study will end when all participants have discontinued study treatment. The primary endpoints are the percentage of participants with adverse events (AEs).
Other key secondary endpoints include recommended phase 2 dose when administered with induction and consolidation therapy; pharmacokinetics of AG-120 and AG-221 in plasma when administered with induction and consolidation therapy; 2-hydroxyglutarate (2-HG) Levels in Plasma; and Clinical Activity of AG-120 and AG-221 According to the 2003 Revised International Working Group (IWG) Criteria for AML.
About NCT04817761 Phase 2/3 ALL Trial
The NCT04817761 is a U.S., Phase 2/3 multi-center, open-label, single-arm clinical trial to confirm the recommended doses and to evaluate the safety and pharmacokinetics of calaspargase pegol for treatment of adults aged 22 to >65 years with newly-diagnosed Philadelphia-negative acute lymphoblastic leukemia (ALL). The study’s primary endpoint is adverse events (AEs) (Part 1) 30 days after administration at days 4, 5 and 6 in the remission induction phase, AEs (Part 2) 30 days after the last dose of the study drug in delayed intensification phase, plasma asparaginase activity (PAA) (Part 1) days 4, 5 and 6 for PAA samples, and nadir plasma asparaginase activity (NPAA) (Part 2).
Other key secondary endpoints include PAA level ≥0.1 U/mL at any time during remission induction phase and post-remission induction phase; PAA level ≥0.025, ≥0.1, ≥0.2, or ≥0.4 U/mL at predefined time points during remission induction phase and post-remission induction phase; PAA-derived maximum concentration (Cmax) after the remission induction phase day 4 dose; PAA-derived area under the PAA-time curve from time 0 to day 21 (AUC 0-21) after the remission induction phase day 4 dose (Part 1 and 2); minimal residual disease (MRD); complete remission (CR); survival, event-free survival (EFS),disease-free survival (DFS) and overall survival (OS), 2-year EFS, DFS, OS, 3-year EFS, DFS, OS; anti-drug (calaspargase pegol) antibody (ADA) development (Part 1 and 2).
About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow marked by rapid disease progression and is the most common acute leukemia affecting adults with approximately 20,000 new cases in the U.S., and 43,000 cases in Europe each year. The majority of patients with AML eventually relapse. Relapsed or refractory AML has a poor prognosis. The five-year survival rate is approximately 27%. For 6% to 10% of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia.
About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is the most common form of childhood acute leukemia. It is a rapidly progressing cancer that starts in the bone marrow and spreads into the blood, where it can cause problems elsewhere in the body, such as in the spleen, thymus, lymph nodes, liver, testicles, and the central nervous system. ALL represents approximately 12% of all leukemia cases worldwide, and about 80% of childhood leukemia cases. The five-year survival rate for children with ALL is now about 90%.