Linvoseltamab-gcpt

Bengaluru: Regeneron said on Friday its experimental therapy showed either a complete or partial disappearance of a precancerous disorder , which manifests into blood cancer, in all patients in a mid-stage trial. The bispecific antibody therapy, Lynozyfic , showed a 100% overall response rate in a study with 24 patients with high-risk smoldering multiple myeloma . The data was presented at the annual meeting of the International Myeloma Society in Toronto. SMM is a disorder characterized by abnormal plasma cells in the bone marrow and an abnormal protein in the blood, but without the symptoms or organ damage of active multiple myeloma, a type of blood cancer. The disorder can progress into multiple myeloma. Regeneron estimates that there are around 4,900 new SMM cases in the United States annually, with its high-risk form accounting for about 1,300 to 1,600 of those cases. In the first part of the study the disease disappeared completely in 83.3% of patients after over a year of treatment. In total, 36.8% of patients saw a complete response, however with a median of 3.9 months of treatment. "We know that (responses) will deepen over time," said Andres Sirulnik, Regeneron's clinical development head for hematology. Earlier this year, Lynozyfic was approved for patients with multiple myeloma that has recurred, and who had received at least four other therapies earlier. Sirulnik said testing the therapy in earlier lines of treatment such as in the SMM trial is based on a hypothesis that "we potentially start talking about not just treating cancer, but potentially changing the treatment paradigm in curing a percentage of those patients." Currently there are no approved treatments for the disease in the U.S. Earlier this year, the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee voted in favor of Johnson & Johnson's Darzalex Faspro for the treatment of SMM, indicating a potential approval. (Reporting by Puyaan Singh in Bengaluru; Editing by Shailesh Kuber)

Regeneron reported efficacious early results on its T cell engager Lynozyfic in smoldering multiple myeloma, a precancerous condition that can turn into active multiple myeloma. The study is part of a bid to expand the use of its recently approved bispecific antibody. In the Phase 2 study, all 19 people responded to Lynozyfic, which is also known as linvoseltamab. About three-quarters of patients achieved a “very good partial response,” meaning that levels of an abnormal protein that’s a signal of the disease fell by at least 90% but were still detectable. Regeneron said all responses were ongoing as of May 28. “Our conversation is shifting from treating to potentially — in premalignant conditions — asking the question now, can we cure people? Are we there yet? No,” said Andres Sirulnik, Regeneron’s head of hematology clinical development. “We are asking that question, and that means going to early lines of therapies with a shorter duration or a fixed duration of treatment, and see whether we can obtain long-term remissions,” he said. Regeneron is planning to pit the drug against Johnson & Johnson’s Darzalex in a Phase 3 trial of smoldering multiple myeloma that’s slated to begin late this year or early next year, Sirulnik said. J&J is awaiting an FDA decision on Darzalex Faspro, an injectable version of the drug, in this condition following a favorable advisory committee vote in May. The Tarrytown, NY biotech noted that the safety of Lynozyfic “appeared more favorable” compared to people with more severe disease of relapsed or refractory multiple myeloma. Regeneron reported no ICANS, a form of neurotoxicity, and no treatment discontinuations. It reported that 10 of 24 patients experienced cytokine release syndrome, a side effect of immunotherapies where the immune system overactivates. All of those cases were mild to moderate. Nineteen of 24 patients faced infections, three of which were grade 3. Lynozyfic is a BCMAxCD3 T cell engager, latching onto a protein called BCMA on myeloma cells as well as CD3 on T cells. By bridging the two together, the drug’s goal is to trigger T cells to attack the cancer cells. In July, the FDA granted accelerated approval to Lynozyfic for adults with multiple myeloma who have tried at least four previous treatment regimens. The approval followed an initial rejection last year over manufacturing problems. The new Lynozyfic data cap off an active week of trial readouts for Regeneron — starting with Phase 3 results of an ultra-rare bone disease drug garetosmab , for which the biotech is planning to ask the FDA for approval. Regeneron also shared detailed data on its muscle-sparing regimens for weight loss.