J&J Reports Durable Response in EMD Myeloma With Dual Therapy

• Talvey and Tecvayli combo delivers 78.9% ORR in relapsed/refractory multiple myeloma (RRMM) with extramedullary disease (EMD)
• More than half of the patients achieved complete response or better, with durable outcomes at 13.4 months median follow-up
• No new safety signals observed; low discontinuation rates and favorable tolerability profile

Johnson & Johnson reported positive results from a Phase 2 study of the combination of Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv)—both bispecific antibodies that have been approved by the FDA. 

The study enrolled patients with relapsed/refractory multiple myeloma (RRMM) and extramedullary disease (EMD). EMD is a rare and highly aggressive form of myeloma that is difficult to treat and has a poor prognosis. 

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A total of 90 patients were included in the trial with 84% being triple-class refractory. The combination therapy yielded an overall response rate (ORR) of 78.9%, including 54.4% completing response or better. Durable outcomes were achieved with 66.2% of patients responding at 13.4 months (median follow-up). The one-year progression-free survival was 61% with 74.5% of patients still alive at one year. 

Safety events were consistent with known safety profiles, with low-grade cytokine release syndrome and almost none related to neurotoxicity. Talvey targets GPRC5D, while Tecvayli targets BCMA which establishes a dual-antigen targeting hope to overcome myeloma resistance via dual-antigen targeting. These findings indicate this could be a treatment option for patients with hard to treat myeloma with EMD.