Roche Launches Phase III CEVOLUTION Trial of First-in-Class FcRH5/CD3 Bispecific Antibody Cevostamab in Relapsed/Refractory Multiple Myeloma

▎Armstrong

On April 29, 2026, Roche registered a Phase III clinical trial, CEVOLUTION, on Clinicaltrials.gov, investigating the efficacy of FcRH5/CD3 bispecific antibody Cevostamab in combination with pomalidomide and dexamethasone versus standard therapy for the treatment of relapsed multiple myeloma.

Cevostamab is an FcRH5/CD3 bispecific antibody, FcRH5 inAlmost 100% of myeloma cells‌High expression, and expression is independent of BCMA.

Roche has a wide-ranging layout in the field of hematological tumors. Its CD79b ADC holds a commanding position in first-line DLBCL, two CD3/CD20 bispecific antibodies are targeting B-cell lymphoma, while Cevostamab and universal CAR-T are focusing on multiple myeloma.

Cevostamab is the world's first FcRH5/CD3 bispecific antibody, demonstrating excellent efficacy in Phase I clinical trials.

2025 ASHAt the meeting,Data from Arm B of the CAMMA 1 Study on Cevostamab Combined with Pomalidomide and Dexamethasone (Cevos+Pd) for the Treatment of Relapsed/Refractory Multiple Myeloma Officially Released.In the 70mg and 105mg dose groups, the objective response rate (ORR) reached 86.2% and 88.0%, respectively, with very good partial response or better (VGPR+) rates of 72.4% and 76.0%, and complete response or better (CR+) rates of 44.8% and 60.0%, respectively.In patients achieving CR, over 90% reached MRD negativity.。This combination regimen does not cause sustained B-cell depletion in the later stages of treatment, demonstrating a unique profile of immune safety.

Summary

In recent years, there have been continuous new clinical advancements in the field of multiple myeloma (MM), covering various drug formats and novel targets. As a leader in the MM field, Johnson & Johnson has expanded from BCMA to GPRC5D and from CAR-T to bispecific and trispecific T-cell engagers (TCE). Gilead Sciences acquired Arcellx for $7.8 billion, gaining access to a potential best-in-class BCMA CAR-T therapy. Roche’s FcRH5/CD3 bispecific antibody demonstrated promising efficacy in early clinical trials and showed a differentiated immunological safety profile, rapidly advancing to Phase III clinical trials.