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Novartis Terminates Phase 2 Trial of MBG453 with Azacitidine and Venetoclax in AML Patients
By AppliedXL Automation
(AppliedXL)
Termination of Novartis’ Phase 2 Trial for MBG453 in Combination With Azacitidine and Venetoclax in AML Patients
- Novartis has terminated its Phase 2 trial studying the combination of MBG453, Azacitidine, and Venetoclax in AML patients unfit for chemotherapy.
- The trial, which enrolled 90 patients across 28 sites, was originally completed on October 25, 2024, after experiencing a total of 9 changes in the primary completion date, resulting in a delay of 2 years 1 month from the original projection.
- The decision to terminate came following negative results from two trials in the program, leading Novartis to discontinue the program entirely.
This story was triggered by a recent change on clinicaltrials.gov. View the story on AppliedXL for the full experience and to dive deeper into the data. To view the trial on clinicaltrials.gov, click here.
Novartis’s Sabatolimab Program for MDS and AML
- Novartis is conducting a clinical trial program for Sabatolimab in the therapeutic area of Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). The program aims to evaluate the safety and efficacy of Sabatolimab, often in combination with Azacitidine, Venetoclax, and other agents, targeting patients with intermediate to very high risk MDS, those unfit for chemotherapy, and those with measurable residual disease post-transplantation.
- The program spans from Phase 1 to Phase 2 and the most progressed trial detected is in Phase 2, with a projected primary completion date of October 26, 2029.
- The program is being run in the United States, Italy, Japan, Spain, Germany, and an additional 19 countries.
- A total of 8 trials have been identified for this program, with 1 currently active. These trials were identified based on their similarities.
- The total enrollment across all trials in this program is 585 patients, with 33 patients detected in the currently active trial.
- The trials in this program focus on safety, efficacy, complete remission, and progression-free survival in different patient populations.
Similar Programs Detected in the Myelodysplastic Syndromes and Acute Myeloid Leukemia Therapeutic Area
- I-Mab Biopharma Co. Ltd. is conducting trials for Lemzoparlimab and TJ011133 targeting Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML), with a phase range from Phase 1 to Phase 3. The furthest trial has a projected primary completion date of March 31, 2027.
- Celgene is evaluating CC-486 for hematological disorders, focusing on myelodysplastic syndromes, in a program covering Phase 1 to Phase 2 trials. The furthest trial has a projected primary completion date of January 03, 2026.
- Faron Pharmaceuticals Ltd is exploring Bexmarilimab for MDS, CMML, and AML in a program spanning Phase 1 to Phase 2, with the furthest trial projected to complete by April 01, 2025.
- Astex Pharmaceuticals, Inc. is sponsoring trials for ASTX727, Magrolimab, and Venetoclaxtargeting MDS, CMML, and AML, with trials ranging from Phase 1 to Phase 3. The furthest trial has a projected primary completion date of May 01, 2027.
- Bristol-Myers Squibb is conducting trials for Oral Azacitidine targeting DNA methylation in MDS and AML, with a phase range from Phase 1 to Phase 3. The furthest trial has a projected primary completion date of January 31, 2026.
- Syros Pharmaceuticals is testing Tamibarotenefor RARA-positive MDS and AML in a program covering Phase 2 to Phase 3 trials. The furthest trial has a projected primary completion date of November 13, 2024.
- BeiGene is evaluating BGB-11417 for myeloid malignancies in Phase 1 to Phase 2 trials, with the furthest trial projected to complete by February 08, 2028.
- Akeso is conducting trials for AK117 targeting CD47 in higher-risk MDS and AML, with a phase range from Phase 1 to Phase 2. The furthest trial has a projected primary completion date of April 01, 2026.
- AbbVie is sponsoring trials for Venetoclax in higher-risk MDS, spanning Phase 1 to Phase 3. The furthest trial has a projected primary completion date of September 10, 2025.
- GCP-Service International West GmbH is conducting a Phase 2 trial for Imetelstat in high-risk MDS and AML, with the furthest trial projected to complete by September 30, 2025.
Additional Active Programs in Novartis’s Clinical Pipeline
- Novartis’s clinical trial program evaluates Pelacarsen for Atherosclerotic Cardiovascular Disease, focusing on cardiovascular risk reduction and Lp(a) management in Phase 1 to 3 trials, with the furthest trial having a projected primary completion date of August 24, 2028.
- The efficacy and safety of Ianalumab and VAY736are being assessed for autoimmune diseases in Phase 1 to 3 trials, aiming for sustained remission and safety, with a projected primary completion date of July 16, 2030 for the most advanced trial.
- Remibrutinib is being tested for Chronic Spontaneous Urticaria in Phase 1 to 3 trials, targeting efficacy and safety, with the most progressed trial expected to complete by March 22, 2027.
- The program for Remibrutinib in Relapsing Multiple Sclerosis is in Phase 3 trials, focusing on efficacy and safety, with the primary completion date for the furthest trial being February 10, 2030.
- KLU156 is under evaluation for uncomplicated malaria in a Phase 3 trial, comparing its efficacy to Coartem, with a completion date projected for July 07, 2025.
- The Ianalumab program for Primary Sjögren’s Syndrome is in Phase 2 to 3 trials, focusing on long-term safety and efficacy, with the primary completion date set for August 21, 2028.
- Radioligand therapies like 225Ac-PSMA-617 and others are being tested for prostate cancer in Phase 1 to 3 trials, with the most progressed trial’s completion date being May 09, 2028.
- Remibrutinib is being tested for moderate to severe hidradenitis suppurativa in Phase 3 trials, with the primary completion date projected for September 21, 2028.
- Iptacopan is under evaluation for primary IgA nephropathy in Phase 2 to 3 trials, focusing on proteinuria reduction, with the furthest trial completing on November 11, 2032.
- Lutetium (177Lu) Vipivotide Tetraxetan is being tested for castration-resistant prostate cancer in Phase 1 to 3 trials, with a focus on progression-free survival, and the most advanced trial completing by December 21, 2027.
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