SOHO Italy 2025 | LINKER-MM1 trial update and the potential approval of linvoseltamab for R/R myeloma

Linvoseltamab is a BCMA bispecific antibody that’s currently under investigation in multiple myeloma. It’s under investigation in several different areas of multiple myeloma – in late relapsed/refractory multiple myeloma through the LINKER-MM1 study, for earlier relapsed/refractory multiple myeloma through the LINKER-MM3 study, and even in newly diagnosed myeloma patients through the LINKER-MM4 study. 

And so the original LINKER-MM1 study was a pivotal Phase I/II study for relapsed/refractory multiple myeloma. They evaluated heavily pre-treated multiple myeloma patients with linvoseltamab at 200 milligrams initially once a week, which was then de-escalated to every other week for cycles three through six, and then once every four weeks, starting cycle number seven, if a patient attained a very good partial response or better. 

And the responses were quite impressive with a 71% overall response rate. Over half of patients had a complete response or better. And the responses seem very durable and at an extended follow-up, the median progression-free survival has still not been reached for this drug. 

And so, you know, this is a very promising drug for multiple myeloma. It’s currently under review by the regulatory agencies, such as the FDA, for potential approval later this year. And so we’ll see where this drug ends up in terms of the availability for our patients, hopefully later this year.

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