- |||||||||| itacitinib (INCB039110) / Incyte, Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date, Pan tumor: Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO) (clinicaltrials.gov) - Aug 20, 2021 P1/2, N=105, Not yet recruiting, Trial completion date: Mar 2021 --> Dec 2024 | Trial primary completion date: Mar 2021 --> Dec 2024 Trial completion date: Feb 2025 --> Aug 2025 | Trial primary completion date: Feb 2024 --> Aug 2024
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Xospata (gilteritinib) / Astellas, Inqovi (decitabine/cedazuridine) / Otsuka
New P1/2 trial: NCI-2021-06095: ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Aug 17, 2021 P1/2, N=42, Recruiting,
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Journal: Decitabine and Cedazuridine. (Pubmed Central) - Jul 21, 2021 Active, not recruiting --> Recruiting No abstract available
- |||||||||| cedazuridine/azacitidine (ASTX030) / Otsuka, Onureg (azacitidine oral) / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
[VIRTUAL] Industry Supported Session 04- Not Included in main event CME/CPD Credit () - Jul 9, 2021 - Abstract #MDS2021MDS_74; We will review the clinical data which led to the approval of oral decitabine and cedazuridine, including new overall survival data from the ASCERTAIN Phase 3 clinical trial, and will outline how Astex is continuing to develop the product to address the emerging new standards of care for the treatment of AML and MDS. We will also outline some of the other products being developed by Astex for the treatment of hematological malignancies and solid tumors, including an oral azacitidine and cedazuridine product which uses the same fixed dose combination concept as oral decitabine and cedazuridine to deliver an equivalent pharmacokinetic exposure to IV or SC azacitidine.
- |||||||||| Jakafi oral (ruxolitinib) / Novartis, Incyte, Inqovi (decitabine/cedazuridine) / Otsuka
Review, Journal: Contemporary risk stratification and treatment of chronic myelomonocytic leukemia. (Pubmed Central) - Jul 7, 2021 Recently, oral decitabine with cedazuridine was approved and represents a convenient treatment option for CMML patients...Ruxolitinib may be effective in ameliorating proliferative symptoms and splenomegaly. Allogeneic stem cell transplantation remains the only treatment with curative potential, however novel therapies are in clinical development which may significantly alter the therapeutic landscape of CMML.
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Review, Journal: Decitabine/Cedazuridine: First Approval. (Pubmed Central) - Jun 30, 2021 Clinical studies for AML, glioma and solid tumours are underway in several countries worldwide. This article summarizes the milestones in the development of decitabine/cedazuridine leading to this first approval for the treatment of MDS and CMML.
- |||||||||| [VIRTUAL] Management Strategies for MDS () - Jun 5, 2021 - Abstract #ASCO2021ASCO_5870;
This article summarizes the milestones in the development of decitabine/cedazuridine leading to this first approval for the treatment of MDS and CMML. Design, eligibility criteria and key endpoints of the ASTX727-01-B and ASTX727-02 (ASCERTAIN) studies evaluating the oral combination of decitabine and cedazuridine for patients with MDS Response rates, duration of response and rates of transfusion independence achieved with oral decitabine/cedazuridine; FDA approval and current clinical role opposite standard IV decitabine Key efficacy and safety endpoints achieved in the randomized Phase III MEDALIST trial leading to the FDA approval of luspatercept for the management of MDS-associated anemia; optimal patient selection for and timing of therapy Activity observed with approved AML therapies (eg, venetoclax, ivosidenib, enasidenib, CC-486) in patients with MDS; current off-protocol role Magrolimab for MDS: Mechanism of action, available data, FDA breakthrough therapy designation and potential clinical role; activity in patients with AML Biologic rationale for the investigation of pevonedistat in combination with azacitidine for patients with higher-risk MDS; FDA breakthrough therapy designation for pevonedistat, ongoing evaluation and potential clinical role
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Preclinical, Journal: Cedazuridine/decitabine: from preclinical to clinical development in myeloid malignancies. (Pubmed Central) - Jun 1, 2021 Phase 2 data confirmed bioequivalence of C-DEC when compared with parenteral decitabine, and a larger phase 3 trial has demonstrated similar results, leading to the FDA approval of C-DEC for use in intermediate/high-risk myelodysplastic syndrome (MDS) and CMML. This review will focus upon the current role of HMA therapy in MDS/CMML, preclinical and clinical development of C-DEC, and potential roles of oral HMA therapy in myeloid malignancies moving forward.
- |||||||||| eltanexor (KPT-8602) / Ono Pharma, Karyopharm
Trial completion date, Trial primary completion date: KCP-8602-801: Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications (clinicaltrials.gov) - May 20, 2021 P1/2, N=119, Active, not recruiting, This review will focus upon the current role of HMA therapy in MDS/CMML, preclinical and clinical development of C-DEC, and potential roles of oral HMA therapy in myeloid malignancies moving forward. Trial completion date: Mar 2021 --> Aug 2024 | Trial primary completion date: Mar 2021 --> Aug 2024
- |||||||||| azacitidine / Generic mfg.
Review, Journal: Myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes: a focused review. (Pubmed Central) - May 5, 2021 While these agents epigenetically restore hematopoiesis in a subset of responding patients, they do not impact mutational allele burdens and eventual disease progression to AML remains inevitable. Newer treatment modalities exploiting epigenetic, signaling and splicing abnormalities commonly seen in CMML are much needed.
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Clinical, P2 data, PK/PD data, Journal: Oral cedazuridine/decitabine: a phase 2, pharmacokinetic/pharmacodynamic, randomized, crossover study in MDS and CMML. (Pubmed Central) - Mar 10, 2021 P1/2 Oral cedazuridine/decitabine (100/35 mg) produced similar systemic decitabine exposure, DNA demethylation, and safety vs decitabine 20 mg/m2 IV in the first 2 cycles, with similar efficacy. ClinicalTrials.gov NCT02103478.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Trial initiation date, Combination therapy: Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - Mar 2, 2021 P2, N=40, Recruiting, Trial completion date: Dec 2020 --> Jun 2023 | Trial primary completion date: Dec 2020 --> Jun 2023 Not yet recruiting --> Recruiting | Initiation date: May 2021 --> Feb 2021
- |||||||||| Revlimid (lenalidomide) / BMS, Reblozyl (luspatercept-aamt) / Acceleron, BMS, Inqovi (decitabine/cedazuridine) / Otsuka
Journal: Myelodysplastic Syndromes: 2021 update on Diagnosis, Risk-stratification and Management. (Pubmed Central) - Dec 31, 2020 At the present time there are no approved interventions for patients with progressive or refractory disease particularly after HMA based therapy. Options include participation in a clinical trial or cytarabine based therapy or alloSCT.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), guadecitabine (SGI-110) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date, Combination therapy: HyPeR: Combination Study of Guadecitabine/ASTX727 and Pembrolizumab (clinicaltrials.gov) - Nov 17, 2020 P1, N=34, Active, not recruiting, Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
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