For Health Care Providers
The Cervino (M22-574) Study is an open label phase 3, randomised study designed to evaluate the safety profile, tolerability, preliminary efficacy, and pharmacokinetics of ABBV-383 in comparison to combinations of pre-existing standard of care treatments for R/R MM.
ABBV-383 is a gene recombinant product (biopharmaceuticals) manufactured via Chinese hamster ovary cell line. ABBV-383 is a fully human bispecific antibody that is designed to target BCMA on the surface of MM cells and CD3 on the surface of T-cells, resulting in T-cell activation and selective destruction of BCMA-positive MM cells. Preliminary results from first-in-human Phase 1 and 2 studies of ABBV-383 monotherapy, as well as combination therapy, suggest that ABBV-383 is active in R/R MM
(D’Souza A, Shah N, Rodriguez C, et al. A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen x CD3 Bispecific T-Cell Redirecting Antibody, in Patients with Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2022 Aug27; JCCO2201504. DOI: 10.1200/JCO.22.01504. Online ahead of print.).
For Health Care Providers
The Cervino (M22-574) Study is an open label phase 3, randomised study designed to evaluate the safety profile, tolerability, preliminary efficacy, and pharmacokinetics of ABBV-383 in comparison to combinations of pre-existing standard of care treatments for R/R MM.
ABBV-383 is a gene recombinant product (biopharmaceuticals) manufactured via Chinese hamster ovary cell line. ABBV-383 is a fully human bispecific antibody that is designed to target BCMA on the surface of MM cells and CD3 on the surface of T-cells, resulting in T-cell activation and selective destruction of BCMA-positive MM cells. Preliminary results from first-in-human Phase 1 and 2 studies of ABBV-383 monotherapy, as well as combination therapy, suggest that ABBV-383 is active in R/R MM
(D’Souza A, Shah N, Rodriguez C, et al. A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen x CD3 Bispecific T-Cell Redirecting Antibody, in Patients with Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2022 Aug27; JCCO2201504. DOI: 10.1200/JCO.22.01504. Online ahead of print.).
Cervino is a Phase 3 clinical study of an investigational drug combination that is not approved by the US FDA or any other global health authorities in R/R MM. Safety and efficacy have not been confirmed in R/R MM.
To determine if your patient may be eligible to participate in the study, they must meet all criteria found in the study protocol. The following highlights key eligibility criteria for the Cervino Study:
- Subjects must have a diagnosis of R/R MM during or after the subject’s last treatment.
- Subjects must have measurable disease within 28 days prior to randomisation.
- Subjects must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD and an anti-CD38 mAb.
- Subjects must have a eGFR ≥ 30 mL/min within 2 weeks prior to the first dose of the investigational drug.
- Subjects received BCMA-targeted therapy.
- Subjects received a peripheral autologous SCT within 12 weeks, or an allogeneic SCT within 1 year of the first dose of investigational drug treatment.