TARRYTOWN, N.Y., May 21, 2026
Regeneron Pharmaceuticals announced highly encouraging early clinical data from the Phase 1/2 LINKER-AL2 trial evaluating Lynozyfic® (linvoseltamab) monotherapy in patients with second-line-plus systemic amyloid light chain (AL) amyloidosis, a rare and life-threatening blood disorder with no approved therapies after first-line treatment failure. The data, which will be presented during an oral session at the 2026 ASCO Annual Meeting, showed rapid, deep, and durable hematologic responses, including a 100% complete response (CR) rate at the highest tested dose level, highlighting Lynozyfic’s potential as a breakthrough therapy in relapsed or refractory AL amyloidosis.
Rapid Hematologic Responses and Organ Improvement
The ongoing LINKER-AL2 study is evaluating fixed-duration Lynozyfic monotherapy in adults previously treated for systemic AL amyloidosis. In the preliminary analysis, 20 patients received either 80 mg or 240 mg subcutaneous doses of Lynozyfic, including a majority who had already received daratumumab-containing regimens. Results demonstrated that all treated patients achieved hematologic responses, with patients in the 240 mg cohort achieving a 100% hematologic complete response rate. At the lower 80 mg dose, 71% of patients achieved complete response while all participants achieved at least a very good partial response (VGPR)..
Importantly, free light chain normalization occurred by day 15 across all dose levels, demonstrating extremely rapid plasma cell suppression. The median time to complete response was just 47 days, significantly faster than historical data seen with current frontline quadruplet regimens. Additionally, investigators reported meaningful organ improvements despite relatively short follow-up periods. Among evaluable patients, 73% demonstrated renal improvement while 50% showed cardiac biomarker improvement, a major finding given that cardiac involvement is one of the leading causes of death in AL amyloidosis.
Dr. Hans Lee of the Sarah Cannon Research Institute described the findings as “remarkable,” noting that the nearly universal complete response rates compare favorably against existing first-line treatment combinations and may represent a major advancement for patients facing relapsed or refractory disease.
Safety Profile Consistent with BCMAxCD3 Therapies
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Lynozyfic’s safety profile was generally consistent with other BCMAxCD3 bispecific antibodies currently used in hematologic cancers. The most commonly reported treatment-emergent adverse events included cytokine release syndrome (CRS), neutropenia, infusion-related reactions, and infections. Notably, no Grade 3 or higher CRS events were observed. Most adverse events were manageable and resolved during treatment, allowing the majority of patients to continue therapy.
One patient discontinued due to pneumonia after achieving complete response, while two deaths were reported in patients with significant pre-existing cardiac conditions; investigators determined one cardiac-related fatality to be unrelated to Lynozyfic treatment. Despite these events, investigators highlighted the manageable safety profile alongside the unusually strong efficacy signals observed in heavily pretreated patients.
Lynozyfic is already approved in certain settings for relapsed or refractory multiple myeloma, and Regeneron is now expanding development into plasma cell disorders beyond myeloma, including AL amyloidosis and precursor conditions.
Regeneron Expands Hematology Pipeline with Registrational Phase 2 Study
The ongoing Phase 2 portion of LINKER-AL2 carries registrational intent, signaling Regeneron’s ambitions to pursue regulatory approval if the promising early findings continue. Systemic AL amyloidosis affects approximately 4,400 patients annually in the United States and remains a devastating disease due to progressive amyloid deposition in critical organs such as the heart and kidneys.
Lynozyfic was developed using Regeneron’s proprietary VelocImmune® technology and functions as a BCMAxCD3 bispecific antibody, redirecting T-cells to eliminate abnormal plasma cells producing toxic light chains. Beyond AL amyloidosis, the company is advancing a broad clinical development program exploring Lynozyfic in multiple myeloma across earlier treatment lines and combination regimens.
The latest LINKER-AL2 results reinforce growing industry momentum around bispecific antibody therapies in hematologic diseases and position Lynozyfic as a potentially transformative option for patients with relapsed systemic AL amyloidosis, where therapeutic choices remain extremely limited.
Source: Regeneron press release
