Roche Advances First-in-Class FcRH5/CD3 Bispecific Antibody Cevostamab into Phase III Trial for Relapsed/Refractory Multiple Myeloma
Roche
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On September 23, 2025, Roche held its "Pharma Day" event for this year. During the event, Roche announced the upcoming launch of its FcRH5/CD3 bispecific antibody.Cevostamab'sPhase III Clinical Study and Named asCevolution。
The phase III trial, named "Cevolution" and planned to launch in 2026, will test the efficacy of cevostamab combined with pomalidomide and dexamethasone in the treatment of relapsed or refractory multiple myeloma at second-line and above. At the event, Roche also highlighted data from the phase I Camma 1 trial of the same combination regimen for second-line and above treatment: among 54 patients, the overall response rates for cevostamab at doses of 70mg and 105mg reached 86% and 88%, respectively. According to Roche's disclosure, the incidence of grade 3 infections was less than 30%.
Roche Skips Phase II, DecidesCevostamab Pushed to Phase III to a Certain ExtentIt is a risky move since the efficacy of this target has not been validated. Moreover, there are hardly any players in this field developing similar molecules; currently, only a few assets from Legend Biotech and Moderna are in the early stages of testing. Roche hopes it can compete with numerous other products vying for market share in multiple myeloma, but at the same time, there are high expectations for cevostamab as part of combination therapies.
The company believes that with the increasing popularity of quadruple therapies containing anti-CD38 antibodies such as Darzalex in first-line treatment, there is a significant unmet medical need in the relapsed/refractory treatment space. Charles Fuchs, Head of Global Oncology and Hematology Development at Roche, pointed out that FcRH5 is expressed on "nearly 100%" of myeloma cells; however, drug development targeting this antigen has faced challenges due to its similarity to other members of the FcRH family.
Competitive Landscape
Other companies still hoping to succeed in this field include Legend Biotech (whose CAR-T project LCAR-F33S has recently entered clinical trials) and Moderna. The latter is developing an mRNA-based asset that can encode three TCE bispecific antibodies targeting BCMA, FcRH5, and GPRC5D within a single product.
Despite the scarcity of projects targeting FcRH5, cevostamab may still face competition from products with different mechanisms of action in the rapidly evolving treatment landscape for multiple myeloma. Legend Biotech and Johnson & Johnson's CAR-T therapy Carvykti, which targets BCMA, has already been approved for second-line treatment. Meanwhile, Johnson & Johnson, Pfizer, and Regeneron aim to expand their respective BCMA-targeting T-cell engagers Tecvayli, Elrexfio, and Lynozyfic from current later-line treatments to earlier lines of therapy.
In addition, several companies are developing trispecific T-cell engagers, including Johnson & Johnson's BCMA x GPRC5D program JNJ-79635322 and AbbVie’s recently licensed Eclinos Granmark BCMA x CD38 program ISB 2001.
However, Fuchs emphasized that cevostamab's novel target and its efficacy and safety profile are expected to make it an "ideal partner for cross-industry multiple myeloma therapies." He added that the company is "actively discussing these combination options with multiple potential companies."
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