CC-486

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Acute Myeloid LeukemiaPilot StudyPlasmacytoma

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

1

Idamycin

Pfizer

Phase 3

592

Xospata

Astellas

Phase 3

243

Fludara

Sanofi

Phase 3

174

Vepesid

AAvyxa

Phase 3

525

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

386

Vanflyta

Daiichi Sankyo

Phase 3

147

Neupogen

EEastern Cooperative Oncology Group

Phase 3

318

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

309

Nexavar

Bayer

Phase 3

1210

Busulfex

Akero Therapeutics

Phase 3

25Show 42 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia3 trials

An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission

Active, not recruiting·Bristol-Myers Squibb·Phase 2·NCT05413018·34 enrolled

CC-486 and Venetoclax for Acute Myeloid Leukemia

Recruiting·UUniversity of Colorado, Denver·Phase 1·NCT05287568·35 enrolled

A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

Completed·Bristol-Myers Squibb·Phase 1·NCT04887857·6 enrolled

Oral1 trial

A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders

Completed·Bristol-Myers Squibb·Phase 2·NCT02494258·5 enrolled

Myelodysplastic Syndromes1 trial

Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).

Completed·Bristol-Myers Squibb·Phase 1/2·NCT01835587·31 enrolled

Myeloid Malignancies1 trial

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Terminated·Gilead·Phase 2·NCT04778410·54 enrolled

Lymphoma1 trial

Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT04639843

14 more indications

Non-Small Cell Lung Cancer1 trial

Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer

Completed·Bristol-Myers Squibb·Phase 2·NCT02250326·240 enrolled

Colorectal Cancer1 trial

A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02512172·27 enrolled

ESS1 trial

Expanded Access for CC-486

Approved for marketing·Bristol-Myers Squibb··NCT03723135

Nasopharyngeal Carcinoma1 trial

Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma

Completed·Bristol-Myers Squibb·Phase 2·NCT02269943·36 enrolled

Hematologic Malignancies1 trial

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

Completed·Bristol-Myers Squibb·Phase 1·NCT02223052·89 enrolled

Plasmacytoma1 trial

A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04174196·21 enrolled

CLE1 trial

Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486

Completed·KKirby Institute·Phase 2·NCT03493646·40 enrolled

Pilot Study1 trial

Pilot Study of CC 486 (Oral Azacitidine) Plus BSC as Maintenance After sc Azacitidine in Elderly HR-IPSS-R MDS Patients

Active, not recruiting·UUniversity of Florence·Phase 2·NCT04806906·11 enrolled

Refractory Solid Tumors1 trial

A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors

Completed·Bristol-Myers Squibb·Phase 1·NCT01478685·169 enrolled

Efficacy and Safety1 trial

Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant

Terminated·Bristol-Myers Squibb·Phase 2·NCT02374099·97 enrolled

Ovarian Cancer1 trial

Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer

Terminated·TTranslational Research in Oncology·Phase 2·NCT02900560·34 enrolled

Follicular Lymphoma1 trial

A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma

Terminated·UUniversity of Chicago·Phase 1/2·NCT04722601·2 enrolled

Cutaneous T-cell lymphoma1 trial

A Phase 1 Study of Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT04447027·26 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Phase 2 Multicenter, Randomized, Placebo Controlled, Double Blind Study to Assess the Safety and Efficacy of CC-486 (Oral Azacitidine) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Plus Placebo in Subjects With Previously Treated Locally Advanced or Metastatic Non-small Cell Lung Cancer

Terminated·Bristol-Myers Squibb·Phase 2·NCT02546986·100 enrolled

Details

Drug Info

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