Forty Seven expects to initiate Phase 3 ENHANCE trial in 2020
Forty Seven is focused on advancing magrolimab in registration-enabling programs for the treatment of patients with untreated, higher-risk myelodysplastic syndrome and heavily-pretreated, relapsed or refractory diffuse large B-cell lymphoma. Magrolimab has previously been granted Fast Track designation by the FDA for the treatment of MDS and acute myeloid leukemia, and for the treatment of relapsed or refractory DLBCL and follicular lymphoma, as well as Orphan Drug designation by the U.S. Food and Drug Administration and European Medicines Agency for the treatment of AML. In December 2019, the FDA granted Orphan Drug designation to magrolimab for the treatment of MDS. The company expects to achieve the following milestones in 2020: Myelodysplastic Syndrome: Initiate Phase 3 ENHANCE trial evaluating the combination of magrolimab and azacitidine compared to azacitidine alone in patients with untreated, higher risk-MDS in the second quarter; Present updated data from the ongoing Phase 1b clinical trial evaluating the combination of magrolimab and azacitidine in untreated patients with higher risk MDS mid-year; Complete enrollment in the ongoing Phase 1b clinical trial in the third quarter. Diffuse Large B-Cell Lymphoma: Initiate single-arm, registration-enabling trial evaluating the combination of magrolimab and rituximab in heavily pre-treated relapsed or refractory DLBCL patients who have failed at least two prior lines of therapy in the first quarter; Present initial data from the registration-enabling trial in the fourth quarter.