Bayer announces presentation of new Phase II ARASEC data on NUBEQA

New data from the Phase II ARASEC trial show NUBEQA plus androgen deprivation therapy resulted in a 71% reduction in the risk of progression or death per CHAARTED criteria compared to ADT alone in U.S. patients with metastatic castration-sensitive prostate cancer. NUBEQA plus ADT was also associated with significant improvements in overall survival, time to metastatic castration-resistant prostate cancer, and radiological progression-free survival vs a matched ADT alone arm from a historical control. Some notable limitations of the study include: open-label Phase II study design, the absence of randomization, and the use of historical external control. Primary results are being presented as a plenary session during the American Urological Association Annual Meeting. NUBEQA is indicated in the U.S. for the treatment of adult patients with mCSPC, both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer. In the ARASEC trial, no new safety signals were observed in the NUBEQA plus ADT arm, consistent with previous studies. Safety results were reported descriptively for the NUBEQA plus ADT arm only, as safety data were not routinely collected in the CHAARTED ADT-alone arm. In the NUBEQA plus ADT matched population, 58% of treatment-emergent adverse events were grade 1/2 and 8% discontinued NUBEQA due to TEAEs.