Bispecific antibodies targeting BCMA and GPRC5D were initially approved in late-line multiple myeloma for patients with at least 4 prior lines of therapy who were triple-class exposed to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Since then, randomized phase 3 trials have shown improvements in progression-free and overall survival with these agents compared with standard therapy in earlier relapse. Additionally, the FDA has approved teclistamab-cqyv (Tecvayli) plus daratumumab (Darzalex) for patients after at least 1 prior line of therapy.
Hans Lee, MD, director of Myeloma Research at Sarah Cannon Research Institute in Nashville, Tennessee, spoke with CancerNetwork® about how he characterizes the current stage of this shift toward earlier use of bispecific antibodies.
Transcript:
CancerNetwork: Bispecific antibodies have moved quickly from late-line, heavily pretreated indications to being studied and even approved earlier in the treatment course. How would you characterize the current stage of that evolution across the field right now?
There [was] certainly a lot of excitement when bispecific antibodies targeting BCMA and GPRC5D were approved in late-line myeloma. Initial approvals were in patients with at least 4 prior lines of therapy, triple-class exposed to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. In the last year or so, we have seen multiple trial readouts looking at bispecific antibodies in randomized phase 3 studies, demonstrating that bispecific antibodies targeting BCMA and GPRC5D not only improve progression-free survival but also overall survival compared with standard conventional therapies in patients with early relapsed/refractory multiple myeloma. There is a number of pending phase 3 trial readouts in this space that we expect to be positive as well.
We are seeing a shift of bispecific antibodies into earlier-line myeloma. Now, we have teclistamab plus daratumumab approved [after] at least 1 prior line of therapy,1 and we would expect more to come soon thereafter. In newly diagnosed myeloma, there are also many clinical trials evaluating bispecific antibodies, both as part of induction therapy and as part of consolidation, and these trials are very promising and very exciting. It will only be a matter of time before we incorporate these agents in newly diagnosed patients as well.
Reference
FDA grants third approval under the National Priority Voucher Program. News release. FDA. March 5, 2026. Accessed August 14, 2026. https://tinyurl.com/45hhbpau
