Regeneron Pharmaceuticals (REGN -2.4%) announces positive initial data from an open-label Phase 1/2 dose-escalation study evaluating REGN5458 in multiple myeloma (MM) patients who have exhausted all therapeutic options. The results were presented at ASH in Orlando.
The overall response rate (ORR) in the first two dose arms was 57% (n=4/7), including a 75% ORR (n=3/4) in the higher dose (6 mg weekly) group. Two of the participants in the latter showed no cancer cells in their bone marrow.
On the safety front, no neurotoxicity, dose-limiting toxicities or treatment-related discontinuations were observed. The most common REGN5458-related adverse events were lymphopenia (71%), anemia (57%), thrombocytopenia (43%) and cytokine release syndrome (43%). Serious/life-threatening treatment-related adverse events were observed in five (71%) subjects, including lymphopenia (n=3), hypertension (n=2) and anemia, atrial fibrillation, fatigue, febrile neutropenia, pain in extremity, septic shock and thrombocytopenia (one each).
Additional data should be available in 2020.
REGN5458 is a BCMAxCD3 bispecific antibody designed to bind to BCMA (B-cell maturation antigen) and the CD3 receptor on T cells, bridging them together and activating cancer cell-killing activity of T cells. It is one of six bispecific antibodies that company has in clinical development.
The company has launched another Phase 1 evaluating REGN5459, also a BCMAxCD3 bispecific but with differing binding characteristics, in relapsed/refractory MM.
#ASH19
Regeneron Pharmaceuticals (REGN -2.4%) announces positive initial data from an open-label Phase 1/2 dose-escalation study evaluating REGN5458 in multiple myeloma (MM) patients who have exhausted all therapeutic options. The results were presented at ASH in Orlando.
The overall response rate (ORR) in the first two dose arms was 57% (n=4/7), including a 75% ORR (n=3/4) in the higher dose (6 mg weekly) group. Two of the participants in the latter showed no cancer cells in their bone marrow.
On the safety front, no neurotoxicity, dose-limiting toxicities or treatment-related discontinuations were observed. The most common REGN5458-related adverse events were lymphopenia (71%), anemia (57%), thrombocytopenia (43%) and cytokine release syndrome (43%). Serious/life-threatening treatment-related adverse events were observed in five (71%) subjects, including lymphopenia (n=3), hypertension (n=2) and anemia, atrial fibrillation, fatigue, febrile neutropenia, pain in extremity, septic shock and thrombocytopenia (one each).
Additional data should be available in 2020.
REGN5458 is a BCMAxCD3 bispecific antibody designed to bind to BCMA (B-cell maturation antigen) and the CD3 receptor on T cells, bridging them together and activating cancer cell-killing activity of T cells. It is one of six bispecific antibodies that company has in clinical development.
The company has launched another Phase 1 evaluating REGN5459, also a BCMAxCD3 bispecific but with differing binding characteristics, in relapsed/refractory MM.
#ASH19
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