ASCO 2026 | First results of LINKER-AL2: linvoseltamab in patients with R/R systemic AL amyloidosis

Yeah, so at this year’s ASCO 2026 meeting, I presented initial results of a phase one/phase two study of linvoseltamab in relapsed/refractory light chain amyloidosis, known as the LINKER-AL2 study. Just as a little background, light chain amyloidosis is a rare clonal plasma cell disorder. It’s associated with significant morbidity and mortality, and there’s no approved treatment options in the relapsed/refractory setting. So in this study, we evaluated linvoseltamab, which is a BCMA bispecific antibody approved for the treatment of relapsed/refractory multiple myeloma, and studied it in the setting of relapsed/refractory light chain amyloidosis. So in terms of the study design, it’s a two-part study of phase one and a phase two part of the study. We reported the phase one dose escalation results. 

So eligible patients or patients with a confirmed diagnosis of light chain amyloidosis and had at least one prior line of therapy. In the dose escalation, we looked at two different doses of linvoseltamab, either 80 milligrams or 240 milligrams. And patients were dosed for a minimum of 12 cycles and a maximum of 24 cycles. And so as of the data cut off of April of 2026, 20 patients have been dosed so far on the study. Patients had had a median of one prior line of therapy with 60% of patients with prior daratumumab exposure. 

In terms of the safety findings so far, we’re very encouraged. There have been no dose-limiting toxicities to date. The most common adverse event is cytokine release syndrome, which was predominantly low-grade in nature, so mostly grade one, some grade two, and no grade three or higher CRS events. Infections occur in a quarter of patients of grade three or higher in severity, but all infections resolve with routine clinical care. What was most striking about the study was really the efficacy we’re seeing though. So among 20 patients dosed on study, 100% of patients have achieved a hematologic very good partial response or better, and 90% of patients have achieved a hematologic complete response. And it’s not just the depth of response that we’re seeing, but it’s really the time to response. The median time to onset of hematologic CR is one and a half months. And the median time to normalization of the involved free light chain is only 2.1 weeks. And these really rapid and deep hematologic responses have translated into high rates of organ response. We’re seeing 50% cardiac response rate, 73% renal response rate. So very, very encouraging results so far. So we’re very excited and encouraged by these initial phase one findings from the LINKER-AL2 study. And based on these results, the part two, phase two part of the study is currently enrolling with potential registrational intent.

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