As of August 2025, the drug is in late-stage clinical development for patients with relapsed or refractory multiple myeloma (RRMM), particularly those who have exhausted standard treatment options.[2]
Mechanism of action
Cevostamab is a bispecific T-cell engager antibody that facilitates T cell-mediated killing of multiple myeloma cells through a dual-targeting mechanism.[3]
The antibody binds simultaneously to two distinct targets: FcRH5 (Fc receptor-like 5) expressed on the surface of myeloma cells, and CD3 expressed on T cells.[4] FcRH5 is particularly attractive as a therapeutic target because it is expressed on myeloma cells with near 100% prevalence, making it an ideal target for immunotherapy.[4]
By creating a bridge between the cancer cells and immune effector cells, cevostamab redirects T cells to recognize and eliminate myeloma cells, even in patients who have become resistant to other treatments.[5]
Administration
Cevostamab is administered as an intravenous infusion.[6] The specific dosing regimen is determined based on the clinical trial protocol and patient factors.
Clinical development
Phase I studies
The initial Phase I dose-escalation study (GO39775; NCT03275103) evaluated the safety, pharmacokinetics, and activity of cevostamab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma.[7] Results from this study demonstrated that cevostamab was clinically active and had a manageable toxicity profile.[7][8]
Phase II studies
The clinical development program includes several Phase II studies under the CAMMA (Cevostamab in Multiple Myeloma Assessment) program:
CAMMA 1 study
CAMMA 1 (NCT04910568) is a multicenter Phase Ib trial evaluating the safety, pharmacokinetics, and activity of cevostamab-containing regimens in patients with relapsed or refractory multiple myeloma.[9] The study evaluates cevostamab in combination with pomalidomide and dexamethasone (Pd), cevostamab plus daratumumab and dexamethasone (Dd), and cevostamab monotherapy.[9][10]
CAMMA 2 study
CAMMA 2 is a Phase I/II trial specifically designed for patients with triple-class refractory multiple myeloma who have previously received BCMA-targeted therapies.[11] This study addresses a critical unmet medical need, as it enrolls patients who have exhausted most available treatment options, including those who have received prior BCMA-targeted antibody-drug conjugates, CAR T-cell therapy, or bispecific antibodies.[11][12]
Recent data from CAMMA 2 presented in 2024 showed that cevostamab has manageable safety in patients with triple-class refractory multiple myeloma who have received prior BCMA-targeted therapies.[13] However, clinical responses were observed to be less frequent in patients who had received prior bispecific antibodies compared to those who had received antibody-drug conjugates or CAR T-cell therapy.[13]
Safety profile
Clinical studies have demonstrated that cevostamab has a manageable safety profile in heavily pretreated patients with relapsed or refractory multiple myeloma.[7] The drug has shown clinical activity even in patients with triple-class refractory disease, representing one of the most challenging patient populations to treat.[13]
Target population
Cevostamab is being developed for patients with relapsed or refractory multiple myeloma, with particular focus on those who have:
The drug represents a potential treatment option for patients in the post-BCMA therapy setting, addressing a significant unmet medical need in multiple myeloma treatment.[14]
Development history
Cevostamab was developed by Genentech, a member of the Roche group, under the development codes BFCR4350A and RO7187797.[15] The drug represents part of a new paradigm in multiple myeloma therapy, utilizing the FcRH5 × CD3 bispecific approach to orchestrate T cell-directed assault on myeloma cells.[15]
Regulatory status
As of August 2025, cevostamab has investigational status and has not been approved by any regulatory agency for clinical use. The drug is being evaluated in multiple ongoing clinical trials across different treatment settings in multiple myeloma
↑ Kumar S (2024). "Biomarker Correlates and Clinical Activity of Cevostamab in Patients with Triple-Class Refractory Multiple Myeloma Who Have Received ≥1 Prior B-Cell Maturation Antigen-Targeted Bispecific Antibody". Blood. 144 (Supplement 1): 4732. doi:10.1016/j.blood.2024.S1.4732 (inactive 20 August 2025).{{cite journal}}: CS1 maint: DOI inactive as of August 2025 (link)
1 2 Kumar S, Bachier CR, Cavo M, Corradini P, Delforge M, Janowski W, etal. (2023). "CAMMA 2: A phase I/II trial evaluating the efficacy and safety of cevostamab in patients with relapsed/refractory multiple myeloma who have triple-class refractory disease and have received a prior anti-B-cell maturation antigen agent". Journal of Clinical Oncology. 41 (16_suppl) TPS8064. doi:10.1200/JCO.2023.41.16_suppl.TPS8064.
This page is based on this Wikipedia article Text is available under the CC BY-SA 4.0 license; additional terms may apply. Images, videos and audio are available under their respective licenses.
(what is this?)