Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
Summary
This was a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult participants with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study was to assess clinical effects of MBG453 in combination with azacytidine in adult participants with IPSS-R intermediate, high, very high risk MDS and CMML-2.
Timeline
- Start
- 2020-06-08
- Primary completion
- 2024-10-02
- Completion
- 2024-10-02
Outcome
Missed primary endpoint
Stopped: “In December 2023, Novartis decided to terminate the sabatolimab clinical development program early after Phase II (MDS1) and Phase III (MDS2) studies failed to meet their primary objectives. The termination was not due to safety concerns.”
registry analysis (superiority test); Sabatolimab (MBG453) + Azacitidine vs Placebo + Azacitidine; p = 0.0825; Hazard Ratio (HR) 0.847 (95% CI 0.671 to 1.070) NCT04266301 ↗
registry analysis (superiority test); Sabatolimab (MBG453) + Azacitidine vs Placebo + Azacitidine; Hazard Ratio (HR) 0.863 (95% CI) 0.693 to 1.076 NCT04266301 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sabatolimab | Monoclonal antibody | 800 mg | Intravenous |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Intravenous |