DSP-5336
- Generic Name
- DSP-5336
- Drug Type
- Small Molecule
- Chemical Formula
- C33H43FN6O3
- CAS Number
- 2412555-70-3
- Unique Ingredient Identifier
- VW83Y2JLZ5
- Background
DSP-5336 is a menin inhibitor.
ASH 2024: Novel Therapies and Strategies Advance Hematologic Cancer Treatment
• Bispecific T-cell engagers show promising real-world outcomes for relapsed/refractory large B-cell lymphoma, offering a new treatment avenue.
• Menin-MLL inhibitors like enzomenib demonstrate encouraging Phase 1 results in relapsed/refractory acute leukemia, potentially altering treatment paradigms.
• Odronextamab monotherapy exhibits efficacy in diffuse large B-cell lymphoma progressing after CAR T-cell therapy, addressing a critical unmet need.
• Studies highlight the impact of novel combinations and targeted therapies in improving outcomes for various lymphoma subtypes and multiple myeloma.
Ziftomenib Shows Promise in Treatment of Relapsed/Refractory AML
• Ziftomenib, a selective menin inhibitor, demonstrates promising clinical activity in relapsed/refractory AML patients, especially those with _NPM1_ mutations or _KMT2A_ rearrangements.
• The KOMET-001 trial revealed a 25% complete remission rate in patients with _KMT2A_ rearrangement or _NPM1_ mutations at the 600 mg dose, with a 35% complete remission rate in _NPM1_ mutated patients.
• Ziftomenib exhibits a manageable safety profile, with the most common severe adverse events including anemia, febrile neutropenia, and pneumonia, and a low incidence of _MEN1_ mutation development.
• Ongoing clinical studies are exploring ziftomenib in combination with other therapies, such as 7+3 induction chemotherapy and azacytidine/venetoclax, to enhance its effectiveness in AML treatment.
Revumenib Demonstrates Sustained Responses in Relapsed/Refractory KMT2Ar Acute Leukemia
• Revumenib shows continued clinically meaningful responses in patients with relapsed/refractory _KMT2Ar_ acute leukemia.
• The Phase 2 AUGMENT-101 trial update reveals higher minimal residual disease negativity rates with revumenib.
• Treatment with revumenib led to a significant percentage of patients proceeding to hematopoietic stem cell transplant.
• The safety profile of revumenib remains manageable, with no discontinuations due to differentiation syndrome or QTc prolongation.
FDA's July Roundup: Approvals, Fast Tracks, and Designations in Oncology
• The FDA approved FoundationOne Liquid CDx as a companion diagnostic for niraparib and abiraterone in BRCA-mutated metastatic castration-resistant prostate cancer.
• Several therapies received fast track designations, including OBX-115 for advanced melanoma and ADI-270 for metastatic clear cell renal cell carcinoma.
• Biologics license applications were accepted for remestemcel-L in pediatric steroid-refractory acute graft-vs-host disease and tabelecleucel for Epstein-Barr virus-positive posttransplant lymphoproliferative disease.
• The Oncologic Drugs Advisory Committee voted to require comprehensive phase assessments for new trial designs in perioperative regimens for non-small cell lung cancer.
Drug Development Updates
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