{"id":966237,"date":"2026-05-21T18:26:16","date_gmt":"2026-05-21T22:26:16","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lynozyfic-linvoseltamab-monotherapy-demonstrates-deep-and-rapid-responses-in-all-treated-patients-with-second-line-plus-systemic-amyloid-light-chain-amyloidosis\/"},"modified":"2026-05-21T18:26:16","modified_gmt":"2026-05-21T22:26:16","slug":"lynozyfic-linvoseltamab-monotherapy-demonstrates-deep-and-rapid-responses-in-all-treated-patients-with-second-line-plus-systemic-amyloid-light-chain-amyloidosis","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lynozyfic-linvoseltamab-monotherapy-demonstrates-deep-and-rapid-responses-in-all-treated-patients-with-second-line-plus-systemic-amyloid-light-chain-amyloidosis\/","title":{"rendered":"Lynozyfic\u00ae (linvoseltamab) Monotherapy Demonstrates Deep and Rapid Responses in All Treated Patients with Second-Line-Plus Systemic Amyloid Light Chain Amyloidosis"},"content":{"rendered":"
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\n Normalization of free light chains occurred by day 15 across all doses<\/strong>\n <\/p>\n

\n 100% of patients achieved a hematologic complete response (CR) at the highest tested dose<\/strong>\n <\/p>\n

\n Majority of patients with renal or cardiac involvement demonstrated improvement in organ function, despite short follow-up<\/strong>\n <\/p>\n

\n First results from the Phase 1\/2 LINKER-AL2 trial to be detailed in an ASCO oral presentation; the Phase 2 portion of the trial with registrational intent is ongoing <\/strong>\n <\/p>\n

TARRYTOWN, N.Y., May 21, 2026 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from the Phase 1\/2 LINKER-AL2 trial evaluating Lynozyfic\u00ae<\/sup> (linvoseltamab) in adults with second-line-plus systemic amyloid light chain (AL) amyloidosis, which will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting on Friday, May 29 at 2:45 p.m. CDT. The Phase 2 portion of the trial with registrational intent is underway, part of a broad clinical development program investigating Lynozyfic. Lynozyfic is a BCMAxCD3 bispecific antibody that is already approved to treat certain adults with relapsed or refractory (R\/R) multiple myeloma (MM).<\/p>\n

Systemic AL amyloidosis is a rare and potentially fatal hematologic disorder for which there are currently no approved therapies after initial treatment fails. The disorder is characterized by plasma cells that produce abnormal light chain proteins, which clump together to form amyloid deposits in tissues and vital organs (e.g., heart, kidneys, etc.), resulting in life-threatening organ dysfunction. The current standard-of-care for initial treatment is a four-drug combination that includes daratumumab, bortezomib, cyclophosphamide and dexamethasone. In first-line treatment, this daratumumab-and-chemotherapy-containing quadruple combination showed a 53% hematologic complete response (CR), with a median time to response of 59 days per historical clinical data. In LINKER-AL2, the safety and efficacy of Lynozyfic as a monotherapy was evaluated in patients who received at least one prior therapy, and were either relapsed, refractory or had a suboptimal response (\u201csecond-line-plus\u201d).<\/p>\n

“The nearly 100% hematologic complete response rate in previously treated systemic AL amyloidosis is remarkable given the 53% hematologic complete response rate with the standard-of-care, multi-drug combination in untreated patients with similar median follow up. Coupled with the notable major organ responses seen in those receiving linvoseltamab monotherapy, these data support further investigation as a promising treatment for these patients,\u201d said Hans Lee, M.D., Director of Myeloma Research for Sarah Cannon Research Institute and investigator for the LINKER-AL2 trial. \u201cThe stark reality for patients with systemic AL amyloidosis facing relapsed or refractory disease is that there are no approved treatment options for them. They are grappling with life-threatening organ deterioration, which demands urgent therapeutic innovation. We look forward to the data maturing to better understand if these results can be maintained and translate to further organ improvement.\u201d<\/p>\n

LINKER-AL2 is an ongoing, open-label, Phase 1\/2 trial investigating the safety and efficacy of fixed-duration Lynozyfic monotherapy in adults with second-line-plus systemic AL amyloidosis. The primary endpoint in Phase 1 was the incidence of dose-limiting toxicities through 28 days. In the ongoing Phase 2 portion of the trial, the primary endpoint is the achievement of hematologic CR.<\/p>\n

In the preliminary analysis, 20 patients received Lynozyfic 80 mg (n=7) or 240 mg (n=13) subcutaneously, including 60% who previously received a daratumumab-containing regimen. With a median follow-up of 9.5 months (range: 1.6-13.3 months), Lynozyfic had no observed dose-limiting toxicities, with additional results across both doses showing:<\/p>\n