Clinical and laboratory findings are presented from a 64-year-old female with myelodysplastic syndrome and increased blasts-2 (MDS-IB2) from Phase I/II trial evaluating the anti-IL8 antibody, BMS-986253, in combination with oral decitabine/cedazuridine (NCT05148234). Optical genome mapping identified ETS-related gene, ERG, somatic duplication with post-treatment decreased variant allele frequency. Post-treatment molecular changes with clinical disease stability, suggest IL-8 pathway inhibition biological activity after even short duration.

11 days ago

Journal

KIT (KIT proto-oncogene, receptor tyrosine kinase) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD33 (CD33 Molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • ERG (ETS Transcription Factor ERG)

Inqovi (decitabine/cedazuridine) • BMS-986253

13d

Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia (clinicaltrials.gov)

P1, N=13, Active, not recruiting, OHSU Knight Cancer Institute | Trial completion date: Jun 2026 --> Dec 2026

13 days ago

Trial completion date

TP53 (Tumor protein P53)

TP53 mutation

Rozlytrek (entrectinib) • Inqovi (decitabine/cedazuridine)

25d

A phase 1 study of ASTX727 plus talazoparib in patients with triple-negative or hormone resistant/HER2-negative metastatic breast cancer. (PubMed, Cancer)

ASTX727 plus talazoparib produces significant myelosuppression without other adverse events. Modest methylation changes in PBMCs were detected. There were no objective responses, but some heavily pretreated patients had stable disease for >4 months despite the attenuated doses.

25 days ago

P1 data • Journal • BRCA Biomarker • PARP Biomarker

HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset) • DNMT1 (DNA methyltransferase 1)

HER-2 negative • BRCA mutation

Talzenna (talazoparib) • Inqovi (decitabine/cedazuridine)

26d

Serial Determinations of Molecular Aberrations in Patients with Acute Myeloid Leukemia During Treatment with Oral Decitabine/Cedazuridine. (PubMed, Cancers (Basel))

Disease-modifying activity with decreases in mutated clones is rare. Although the exact mechanism behind our findings remains undetermined, they are in line with the proposed effects of HMA on epigenetics in leukemia cells.

26 days ago

Journal

FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1)

IDH2 mutation • NPM1 mutation • RAS mutation

Inqovi (decitabine/cedazuridine)

2ms

NIBIT-ML-1: A randomized, run-in, phase II study of nivolumab combined with ipilimumab and oral decitabine/cedazuridine (ASTX727) or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1 (2024-518891-29-00)

P1/2, N=148, Recruiting, Fondazione NIBIT Onlus | Not yet recruiting --> Recruiting

2 months ago

Enrollment open

EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

EGFR mutation • BRAF mutation • ALK translocation

Opdivo (nivolumab) • Yervoy (ipilimumab) • Inqovi (decitabine/cedazuridine)

2ms

ASTX030-01: A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) (clinicaltrials.gov)

P2/3, N=316, Recruiting, Taiho Oncology, Inc. | N=236 --> 316 | Trial completion date: May 2028 --> Nov 2028 | Trial primary completion date: May 2027 --> Nov 2027

2 months ago

Enrollment change • Trial completion date • Trial primary completion date

Venclexta (venetoclax) • cedazuridine/azacitidine (ASTX030)

2ms

ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1 (clinicaltrials.gov)

P1/2, N=31, Not yet recruiting, University of Wisconsin, Madison

2 months ago

New P1/2 trial

Inqovi (decitabine/cedazuridine) • Zynyz (retifanlimab-dlwr)

2ms

ETCTN: Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (clinicaltrials.gov)

P2, N=19, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Jan 2027

2 months ago

Trial completion date

Inqovi (decitabine/cedazuridine) • Beleodaq (belinostat) • guadecitabine (SGI-110)

2ms

Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)

P2, N=126, Not yet recruiting, National Cancer Institute (NCI)

2 months ago

New P2 trial

ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • PML (Promyelocytic Leukemia)

Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)

2ms

Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)

P2, N=93, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting

2 months ago

Enrollment open

ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)

IDH2 mutation

Venclexta (venetoclax) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine)

3ms

ASTX660-03: A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) (clinicaltrials.gov)

P1, N=33, Active, not recruiting, Taiho Oncology, Inc. | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2026 --> Mar 2026

3 months ago

Phase classification • Trial completion date

Inqovi (decitabine/cedazuridine) • tolinapant (ASTX660)