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"Since the phase 2 data of the combination therapy of LAE002 (afuresertib) plus LAE001 demonstrated encouraging anti-tumor activity and safety profile in patients with mCRPC, a following phase 3 pivotal trial design has been discussed with the US FDA and the approval for the protocol has been received this month," said Yong Yue, MD, PhD.

Prostate cancer, 3D illustration showing presence of tumor inside prostate gland which compresses urethra | Image Credit: @ Dr_Microbe - stock.adobe.com

The approval is supported by data from the phase 3 EMBARK trial, which demonstrated that enzalutamide with or without leuprolide prolonged metastasis-free survival compared with leuprolide alone in patients with high-risk biochemically recurrent nmHSPC.