- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment closed, Trial completion date, Trial primary completion date: Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes (clinicaltrials.gov) - Jan 18, 2022 P1, N=30, Active, not recruiting, N=45 --> 68 | Trial primary completion date: Feb 2023 --> Feb 2024 Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2023
- |||||||||| tolinapant (ASTX660) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Dec 23, 2021 P1, N=68, Active, not recruiting, Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jan 2022 --> Jan 2023 Recruiting --> Active, not recruiting | Trial completion date: Oct 2021 --> Apr 2022 | Trial primary completion date: Oct 2021 --> Apr 2022
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Inqovi (decitabine/cedazuridine) / Otsuka
Trial completion date, Trial primary completion date, Metastases: Decitabine/Cedazuridine and Enzalutamide for the Treatment of Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov) - Dec 22, 2021 P1b, N=19, Not yet recruiting, Recruiting --> Active, not recruiting | Trial completion date: Oct 2021 --> Apr 2022 | Trial primary completion date: Oct 2021 --> Apr 2022 Trial completion date: Nov 2025 --> Jan 2024 | Trial primary completion date: Nov 2024 --> Jan 2024
- |||||||||| Onureg (azacitidine oral) / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
Journal: The path to approval for oral hypomethylating agents in acute myeloid leukemia and myelodysplastic syndromes. (Pubmed Central) - Dec 16, 2021 CC-486 has been shown to improve overall survival as maintenance therapy for older patients with acute myeloid leukemia in complete remission, whereas the combination of decitabine with cedazuridine, a cytidine deaminase inhibitor, is indicated for the treatment of adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia with intermediate-1, or higher, International Prognostic Scoring System risk. This article briefly summarizes the clinical development of both drugs, the pivotal studies that led to their approval and some of the issues faced in extending the use of these drugs to other indications.
- |||||||||| sabatolimab (MBG453) / Novartis
Trial initiation date: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) - Dec 10, 2021 P2, N=90, Not yet recruiting, This article briefly summarizes the clinical development of both drugs, the pivotal studies that led to their approval and some of the issues faced in extending the use of these drugs to other indications. Initiation date: Aug 2021 --> Nov 2021
- |||||||||| azacitidine / Generic mfg.
Clinical, Review, Journal: Increasing recognition and emerging therapies argue for dedicated clinical trials in chronic myelomonocytic leukemia. (Pubmed Central) - Nov 21, 2021 To date, approved drugs for CMML treatment are HMA, including azacitidine, decitabine, and more recently the oral combination of decitabine and cedazuridine...Several novel agents, such as sotatercept, ruxolitinib, lenzilumab, and tagraxofusp have shown promising clinical efficacy in CMML...This review focuses on recent therapeutic advances and innovative treatment strategies in CMML, including global and molecularly targeted approaches. We also discuss what may help to make progress in the design of rationally derived and disease-modifying therapies for CMML.
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Efficacy of Oral Decitabine/Cedazuridine (ASTX727) in the CMML Subgroup from the Ascertain Phase 3 Study (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5375; In the overall study, oral decitabine/cedazuridine delivered equivalent PK exposure to 5 days of IV decitabine 20mg/m 2 with a resultant clinical activity safety and efficacy profile in CMML patients consistent with the published literature (e.g Zeidan, et al 2017) and the Phase 2 experience. The use of oral decitabine/cedazuridine is a reasonable approach in CMML patients
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, IO biomarker, Metastases: Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients (clinicaltrials.gov) - Oct 29, 2021 P1/2, N=13, Active, not recruiting, References: Garcia-Manero, et al, ASH 2019 Savona, et al, Int. Recruiting --> Active, not recruiting | N=59 --> 13 | Trial completion date: Aug 2024 --> Jan 2025 | Trial primary completion date: Aug 2022 --> Jan 2023
- |||||||||| Opdivo (nivolumab) / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
New P1/2 trial, Combination therapy, Checkpoint inhibition, IO biomarker, Checkpoint block, Metastases: Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma (clinicaltrials.gov) - Oct 21, 2021 P1/2, N=30, Not yet recruiting,
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Trial initiation date: Inqovi Maintenance Therapy in Myeloid Neoplasms (clinicaltrials.gov) - Oct 6, 2021 P1, N=22, Recruiting, Further investigation of oral decitabine/cedazuridine in all-oral combination studies is warranted and underway. Not yet recruiting --> Recruiting | Initiation date: Jan 2022 --> Sep 2021
- |||||||||| azacitidine / Generic mfg.
[VIRTUAL] MECHANISMS AND PREDICTORS OF DRUG RESISTANCE, INTOLERANCE TO HMAS AND CLINICAL MANAGEMENT STRATEGIES IN HIGH RISK MDS () - Sep 26, 2021 - Abstract #MDS2021MDS_293; More recently, machine learning/artificial intelligence statistical approaches have been able to identify patients with discrete combinations of three molecular mutations who are more or less likely to respond to HMAs, and personalized predictive models that incorporate easy-to-obtain clinical variables to predict early in an HMA treatment course whether or not patients will respond to HMAs. Critical to maximizing response likelihoods is maintaining HMA treatment for a minimum of six treatment cycles, either by adjusting route of administration, setting expectations for treatment side effects, or educating patients and health care providers about the association between treatment duration and treatment response.
- |||||||||| sabatolimab (MBG453) / Novartis
[VIRTUAL] STIMULUS MDS-US Trial in Progress: Evaluating Sabatolimab in Combination with Hypomethylating Agents (HMAs) in Patients with Intermediate-, High-, or Very High– Risk Myelodysplastic Syndromes (MDS) () - Sep 6, 2021 - Abstract #SOHO2021SOHO_568; P1b, P2 Main Outcome Measures: Primary endpoints are incidence and severity of adverse events (AEs) and serious AEs. Secondary endpoints are complete remission (CR) rate, progression-free survival, overall survival, leukemia-free survival, percentage of patients with CR/marrow CR/ partial remission, duration of CR, time to CR, and improvement in transfusion independence.
- |||||||||| [VIRTUAL] Use of Oral Hypomethylating Agents for the Treatment of Myelodysplastic Syndromes () - Sep 6, 2021 - Abstract #SOHO2021SOHO_373;
P1, P1/2, Conclusion Long-awaited approval of FDC oral C-DEC 100/35 mg for patients with MDS has paved the way for future development of oral combinations and the possibility of receiving total oral therapy with ease and convenience for patients requiring prolonged duration of therapy. Several trials evaluating oral DEC + cedazuridine in combination with the BCL2 inhibitor venetoclax in MDS (NCT04655755) or IDH inhibitors enasidenib or ivosidenib in AML (NCT04774393) are underway.
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