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BOREAS: Efficacy and safety of navtemadlin in JAKi R/R MF
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Navtemadlin is a potent, selective, oral MDM2 inhibitor that restores p53 function.1 Results from the phase III BOREAStrial (NCT03662126) evaluating the safety and efficacy of navtemadlin vs BAT in 183 patients with TP53wt MF who were R/R to JAK inhibitors were presented by John Mascarenhas at the 66th ASH Annual Meeting and Exposition.1
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| Key learnings |
| At Week 24, the SVR35 assessed by central review MRI/CT (15% vs 5%), driver gene VAF reduction (21% vs 12%), and BM fibrosis (47% vs 24%) were higher with navtemadlin monotherapy compared with BAT. |
| TSS50 at Week 24 (24% vs 12%; p = 0.0507) and absolute change in TSS at Week 24 (p = 0.0078) were higher with navtemadlin monotherapy compared with BAT. |
| Thrombocytopenia (37% vs 25%), anemia (29% vs 28%), neutropenia (25% vs 12%), diarrhea (6% vs 2%), nausea (4% vs 0%), and vomiting (2% vs 0%) were the most frequent Grade 3 or 4 hematologic and GI TEAEs with navtemadlin and BAT, respectively. |
| These findings demonstrate that navtemadlin monotherapy is effective, with an acceptable safety profile and disease-modifying potential, and warrants further studies investigating navtemadlin in MF. |
Abbreviations: BAT, best available therapy; BM, bone marrow; CT. computed tomography; GI, gastrointestinal; JAKi, Janus kinase inhibitor; MF, myelofibrosis; MRI, magnetic resonance imaging; R/R relapsed/refractory; SVR35; spleen volume reduction ≥35%; TSS50, total symptom score reduction ≥50%; VAF, variant allele frequency; WT, wild-type.
- Mascarenhas J. Results from the randomized, multicenter, global phase 3 BOREAS study: Navtemadlin versus best available therapy in jak inhibitor relapsed/refractory myelofibrosis. Oral abstract #1000. 66th American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 10, 2024; San Diego, US.
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