On May 17, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that it has received clearance from the FDA for its investigational new drug application (IND) for Abivertinib (Fujovee) for the Phase 2 MAVERICK study to be conducted in participants with metastatic castrate resistant prostate cancer (mCRPC) at multiple centers in the United States (Press release, Sorrento Therapeutics, MAY 17, 2022, View Source [SID1234614735]). 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 primary objective of the study is to evaluate the efficacy of Abivertinib with abiraterone via an assessment of 6-month radiographic progression-free survival (rPFS) and the primary endpoint is the 6-month rPFS defined as a percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases. Participants will remain on treatment until radiographic progression, unacceptable toxicity, intercurrent illness or other reasons (such as subject withdrawal).
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Extragonadal androgen production requires the activity of 3β-hydroxysteroid dehydrogenase isoenzyme-1 (3β-HSD1) encoded by the HSD3β1 allele and an identified single nucleotide polymorphism (SNP) can create an adrenal-permissive phenotype that allows for more rapid development of mCRPC resulting in earlier castration resistance and shortened overall survival. Increased BTK expression has been observed in various solid tumors, including prostate cancer, and it is believed that the interplay between BTK inhibition and 3βHSD is responsible. BTK inhibition has been shown to inhibit androgen production, particularly from extragonadal precursor steroids, in preclinical models. In addition to selectively targeting both mutant forms of EGFR (T790M and exon 19 and 21 mutations), Abivertinib irreversibly binds to the BTK receptor, preventing phosphorylation of the receptor. Abivertinib is an oral capsule taken twice daily and has been well tolerated across multiple cancer types in doses up to 300 mg twice daily.
The global market for CRPC for 2021 was $2.7 billion, with the U.S. accounting for 67% ($1.83 billion), and a CAGR of 4.15%, projected to reach $4.56 billion, with the U.S. projected to account for 68% ($3.08 billion) by 2031(1).