- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
P1/2 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal, Combination therapy, IO biomarker: MDS-520 A Phase I/II Study of Venetoclax in Combination With ASTX727 (Decitabine/Cedazuridine) in Treatment-Naïve High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML). (Pubmed Central) - Sep 29, 2022 P1/2 Ven+ASTX727 combination appears safe and demonstrates preliminary efficacy in pts with higher risk MDS or CMML with excess blasts. Total-oral regimen of Ven+ASTX727 combination appears to be a promising strategy for high-risk MDS or CMML pts.
- |||||||||| Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Inqovi (decitabine/cedazuridine) / Otsuka
Review, Journal: Diagnosis and Treatment of Myelodysplastic Syndromes: A Review. (Pubmed Central) - Sep 14, 2022 For those with higher-risk MDS, hypomethylating agents such as azacitidine, decitabine, or decitabine/cedazuridine are first-line therapy...Treatments are tailored to the patient's disease characteristics and comorbidities and range from supportive care with or without erythropoiesis-stimulating agents for patients with low-risk MDS to hypomethylating agents, such as azacitidine or decitabine, for patients with higher-risk MDS. Hematopoietic cell transplantation is potentially curative and should be considered for patients with higher-risk MDS at the time of diagnosis.
- |||||||||| BMS-986253 / BMS
Enrollment open: BMS-986253 in Myelodysplastic Syndromes (clinicaltrials.gov) - Sep 9, 2022 P1/2, N=200, Recruiting, Hematopoietic cell transplantation is potentially curative and should be considered for patients with higher-risk MDS at the time of diagnosis. Not yet recruiting --> Recruiting
- |||||||||| Inqovi (decitabine/cedazuridine) / Otsuka
FDA event, Journal: FDA approval summary: decitabine and cedazuridine tablets for myelodysplastic syndromes. (Pubmed Central) - Aug 18, 2022 Adverse reactions were consistent with IV decitabine. Post-marketing assessments were issued to address the effect of cedazuridine on QT prolongation, food effect, moderate and severe hepatic impairment, and severe renal impairment on the pharmacokinetics and safety of DEC-C.
- |||||||||| Lutathera (lutetium Lu 177 dotatate) / Novartis, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Trial initiation date, Metastases: LANTana: Lutathera and ASTX727 in Neuroendocrine Tumours (clinicaltrials.gov) - Jul 18, 2022 P1, N=27, Recruiting, Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2022 --> Jul 2023 Not yet recruiting --> Recruiting | Initiation date: Jan 2022 --> Apr 2022
- |||||||||| Opdivo (nivolumab) / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Trial initiation date, 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) - May 30, 2022 P1/2, N=30, Recruiting, N=119 --> 277 Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> May 2022
- |||||||||| 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) - May 26, 2022 P1, N=34, Active, not recruiting, Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> May 2022 Trial completion date: Jun 2021 --> Sep 2024 | Trial primary completion date: Jun 2021 --> Sep 2024
- |||||||||| sabatolimab (MBG453) / Novartis
SABATOLIMAB (MBG453) COMBINATION TREATMENT REGIMENS FOR PATIENTS WITH HIGHER-RISK MYELODYSPLASTIC SYNDROMES: THE MYELODYSPLASTIC SYNDROMES STUDIES IN THE STIMULUS IMMUNO-MYELOID CLINICAL TRIAL PROGRAM () - May 13, 2022 - Abstract #EHA2022EHA_1812; P2, P3 STIMULUS-MDS2 ( NCT04266301) is an international, randomized, double-blind, placebo-controlled, ph III trial of sabatolimab + azacitidine (AZA) in pts with vH/H/IR-MDS or chronic myelomonocytic leukemia-2; the study has completed recruiting (N=530)...STIMULUS MDS-US (NCT04878432) is a US-based, open-label, single-arm, ph II trial of sabatolimab + HMA of investigator’s choice (AZA intravenous [IV] or subcutaneous, decitabine IV, or oral decitabine/cedazuridine) in pts with vH/H/IR-MDS...STIMULUS-MDS3 (NCT04812548) is an international, open-label, single-arm, ph II trial that explores triplet therapy of sabatolimab + AZA + BCL-2 inhibitor venetoclax (VEN) in pts with vH/HR-MDS...Results None. Conclusion None.
- |||||||||| Opdivo (nivolumab) / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
Trial initiation date, 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) - Apr 28, 2022 P1/2, N=30, Not yet recruiting, Total oral therapy of ASTX727+ven is safe and feasible, particularly in the advanced elderly population, and demonstrates significant efficacy in pts unfit for chemotherapy both in the FL and R/R settings. Initiation date: Mar 2022 --> Mar 2023
- |||||||||| Clinical, Journal: The development and clinical use of oral hypomethylating agents in acute myeloid leukemia and myelodysplastic syndromes: dawn of the total oral therapy era. (Pubmed Central) - Mar 4, 2022
Following the approval of the cedazuridine/decitabine combination, ASTX727, as well as development of an oral formulation of azacitidine, CC-486, in the USA in 2020, these agents could gradually replace their injectable counterparts...However, their FDA-approved indications at this point are narrow and efficacy needs to be shown in clinical trials before considering use beyond the approved indications. Areas of special interest include; identification of predictive biomarkers for clinical benefit, post-transplant maintenance therapy, and potential combination therapies with other oral agents such as venetoclax, IDH and FLT3 inhibitors.
- |||||||||| Beleodaq (belinostat) / Aurobindo, Assertio, guadecitabine (SGI-110) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
Trial suspension, Metastases: ETCTN: Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (clinicaltrials.gov) - Mar 4, 2022 P2, N=32, Suspended, Areas of special interest include; identification of predictive biomarkers for clinical benefit, post-transplant maintenance therapy, and potential combination therapies with other oral agents such as venetoclax, IDH and FLT3 inhibitors. Recruiting --> Suspended
- |||||||||| Onureg (azacitidine oral) / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
Journal: Oral hypomethylating agents: beyond convenience in MDS. (Pubmed Central) - Feb 22, 2022 The availability of oral HMAs may support the optimal application of these agents by contributing to adherence and lessening the burden of therapy, potentially encouraging patients to stay on longer-term treatment. Distinct pharmacokinetic profiles for the recently approved oral HMAs (oral azacitidine and decitabine-cedazuridine) result in differential toxicity profiles and have prompted their clinical trial development in lower- and higher-risk MDS, respectively.
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Inqovi (decitabine/cedazuridine) / Otsuka
Enrollment open, Metastases: Decitabine/Cedazuridine and Enzalutamide for the Treatment of Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov) - Feb 22, 2022 P1b, N=19, Recruiting, Distinct pharmacokinetic profiles for the recently approved oral HMAs (oral azacitidine and decitabine-cedazuridine) result in differential toxicity profiles and have prompted their clinical trial development in lower- and higher-risk MDS, respectively. Not yet recruiting --> Recruiting
- |||||||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD), Inqovi (decitabine/cedazuridine) / Otsuka
Journal: Novel agents for myelodysplastic syndromes. (Pubmed Central) - Feb 9, 2022 Together, our findings indicate that OR21 is a promising candidate drug for phase 1 study as an alternative to azacitidine or decitabine. The novel myelodysplastic syndromes agents luspatercept-aamt and decitabine/cedazuridine provide a clinical benefit in the studied populations.
- |||||||||| sabatolimab (MBG453) / Novartis
Enrollment open: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) - Feb 9, 2022 P2, N=90, Recruiting, The novel myelodysplastic syndromes agents luspatercept-aamt and decitabine/cedazuridine provide a clinical benefit in the studied populations. Not yet recruiting --> Recruiting
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