Topline results for the alpha-isotope based targeted radiopharmaceutical therapy highlight significant improvement in progression-free survival in SSTR-positive GEP-NETs.
RayzeBio’s (a Bristol Myers Squibb company) have presented new, positive topline clinical data for its targeted radiopharmaceutical therapy (RPT) RYZ101 (225Ac-DOTATATE).
The interim analysis outcomes showed significant and clinically meaningful improvement in progression-free survival (PFS) in somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs). It represents the first findings from a Phase III trial of an alpha-based targeted RPT (225Ac).
RYZ101 comprises of DOTATATE bound to Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope. The treatment was evaluated against standard of care (high-dose or high-frequency long-acting somatostatin analogues, everolimus, or sunitinib) in the Phase III ACTION-1 trial.
“The improvement in progression-free survival is a defining moment for RYZ101 and for the patients we built this programme around — people with advanced GEP-NETs whose cancer has progressed after Lu177-based therapy and who have few remaining options”
Dr Amreen Husain, Chief Medical Officer of RayzeBio
Dr Amreen Husain, Chief Medical Officer of RayzeBio, said: “The improvement in progression-free survival is a defining moment for RYZ101 and for the patients we built this programme around — people with advanced GEP-NETs whose cancer has progressed after Lu177-based therapy and who have few remaining options.”
Dr Simron Singh, Medical Oncologist at the University of Toronto, and principal investigator of the ACTION-1 study, explained that “Lu177-based therapy is widely used in GEP-NETs, but unfortunately the vast majority of patients will eventually progress.”
Separate to the outcome of this analysis, patients will be followed so investigators can ascertain how RYZ101 affects overall survival.
Detailed findings of the ACTION-1 study are expected to be presented at a future medical meeting.
As for its potential in additional disease areas, RYZ101 is also being evaluated in earlier-stage trials in hormone receptor-positive (HR+) metastatic breast cancer.
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