- The FDA has signed off Sorrento Therapeutics Inc's (NASDAQ:SRNE) investigational new drug application (IND) for Abivertinib (Fujovee) for Phase 2 MAVERICK study in metastatic castrate-resistant prostate cancer (mCRPC).
- The MAVERICK study will be conducted in a partnership with the Prostate Cancer Clinical Trials Consortium and will enroll participants with both abiraterone-naïve and abiraterone-progressing mCRPC.
- The MAVERICK trial will be conducted as an open-label study of Abivertinib with abiraterone in up to 100 participants harboring the adrenal-permissive HSD3β1 allele (heterozygous or homozygous).
- The study's primary objective is to evaluate the efficacy of Abivertinib with abiraterone for 6-month radiographic progression-free survival (rPFS).
- The primary endpoint is the 6-month rPFS.
- Sorrento Therapeutics' partner, China Oncology Focus Limited, a subsidiary of Lee's Pharmaceutical Holdings Limited, has completed the patient enrollment for a Phase 3 trial of socazolimab in extensive-stage small-cell lung cancer.
- A total of 498 patients have been enrolled in the study. An interim analysis is expected to be conducted in April 2023.
- Price Action: SRNE shares are up 8.68% at $1.57 during the market session on the last check Tuesday.
