By Puyaan Singh
Sept 19 (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 ( JNJ ) Darzalex Faspro for the
treatment of SMM, indicating a potential approval.