By Puyaan Singh
(Reuters) – 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)
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