Alpha1H has received regulatory approval from the European Medicines Agency for its phase III clinical study of the therapy in bladder cancer. The approval represents a milestone for the clinical development of Alpha1H and provides a clear regulatory path toward a potential future marketing application in Europe.
Two drug combinations, Tecvayli (teclistamab-cqyv) + Talvey (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and Talvey + pomalidomide (Pomalyst, sponsored by Bristol Myers Squibb), demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival compared with investigator’s choice standard of care for adult patients with relapsed or refractory multiple myeloma who received 1 to 4 prior lines of therapy, including an anti-CD38 antibody and lenalidomide.
