Trials that led to bispecific antibodies approval in MM and NHL
| Trial name (NCT#) . | Bispecific antibody . | Hematological malignancy . | Population/indication . | Primary end point . | Overall response rate . | FDA approval date . |
|---|---|---|---|---|---|---|
| MajesTEC-1 (NCT04557098) | Teclistamab | MM | Patients who were refractory to at least an IMiD, a PI, and an anti-CD38 antibody, with at least 3 prior lines of therapy, and an ECOG of 0 to 1 | Overall response rate | 63% | 25 October 2022 |
| GO29781 (NCT02500407) | Mosunetuzumab | NHL (FL) | Patients with R/R FL (grade 1 to 3A) with at least 2 prior lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent), and an ECOG 0 to 1 | Complete response | 80% | 22 December 2022 |
| EPCORE NHL-1 (NCT03625037) | Epcoritamab | NHL (DLBCL and FL) | Patients with a relapsed or refractory mature B-cell neoplasm (DLBCL, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, grade 3B FL), with at least 2 prior lines of systemic therapy (including an anti-CD20 antibody), prior failure or ineligibility to ASCT, and an ECOG of 0 to 1 | Overall response rate | 61% (DLBCL) | 19 May 2023 |
| 82% (FL) | 26 June 2024 | |||||
| NP30179 | Glofitamab | NHL (DLBCL) | Patients with a relapsed or refractory mature B-cell neoplasm (DLBCL, transformed FL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma), with at least 2 prior lines of systemic therapy (including an anti-CD20 antibody and an anthracycline) | Complete response | 52% | 15 June 2023 |
| MonumenTAL-1 | Talquetamab | MM | Patients who were refractory to at least an IMiD, a PI, and an anti-CD38 antibody, with at least 4 prior lines of therapy | Overall response rate | 70% | 9 August 2023 |
| MagnetisMM-3 (NCT04649359) | Elranatamab | MM | Patients who were refractory to at least an IMiD, a PI, and an anti-CD38 antibody | Overall response rate | 61% | 14 August 2023 |
| Trial name (NCT#) . | Bispecific antibody . | Hematological malignancy . | Population/indication . | Primary end point . | Overall response rate . | FDA approval date . |
|---|---|---|---|---|---|---|
| MajesTEC-1 (NCT04557098) | Teclistamab | MM | Patients who were refractory to at least an IMiD, a PI, and an anti-CD38 antibody, with at least 3 prior lines of therapy, and an ECOG of 0 to 1 | Overall response rate | 63% | 25 October 2022 |
| GO29781 (NCT02500407) | Mosunetuzumab | NHL (FL) | Patients with R/R FL (grade 1 to 3A) with at least 2 prior lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent), and an ECOG 0 to 1 | Complete response | 80% | 22 December 2022 |
| EPCORE NHL-1 (NCT03625037) | Epcoritamab | NHL (DLBCL and FL) | Patients with a relapsed or refractory mature B-cell neoplasm (DLBCL, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, grade 3B FL), with at least 2 prior lines of systemic therapy (including an anti-CD20 antibody), prior failure or ineligibility to ASCT, and an ECOG of 0 to 1 | Overall response rate | 61% (DLBCL) | 19 May 2023 |
| 82% (FL) | 26 June 2024 | |||||
| NP30179 | Glofitamab | NHL (DLBCL) | Patients with a relapsed or refractory mature B-cell neoplasm (DLBCL, transformed FL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma), with at least 2 prior lines of systemic therapy (including an anti-CD20 antibody and an anthracycline) | Complete response | 52% | 15 June 2023 |
| MonumenTAL-1 | Talquetamab | MM | Patients who were refractory to at least an IMiD, a PI, and an anti-CD38 antibody, with at least 4 prior lines of therapy | Overall response rate | 70% | 9 August 2023 |
| MagnetisMM-3 (NCT04649359) | Elranatamab | MM | Patients who were refractory to at least an IMiD, a PI, and an anti-CD38 antibody | Overall response rate | 61% | 14 August 2023 |
ASCT, autologous stem cell transplantation; ECOG, Eastern Cooperative Oncology Group performance status scale; IMiD, immunomodulatory agent; PI, proteasome-inhibitor.