Abivertinib – EGFR & BTK Inhibitor
Abivertinib inhibits the T790M “gatekeeper” mutation of EGFR and common activating mutations (L858R and del19) but has minimal inhibitory activity towards the normal (wild-type) receptor. The T790M mutation of EGFR is the major cause of acquired resistance and is detected in more than half of patients treated with first-generation EGFR TKIs, such as Tarceva (erlotinib) and Iressa (gefitinib).
Multiple phase 1 and 2 clinical trials have been completed, with over 600 NSCLC patients treated.
Abivertinib is initially being developed as an oral treatment for patients with NSCLC in whom prior EGFR-directed therapy has failed due to the emergence of the EGFR T790M mutation. ACEA is also evaluating abivertinib as first-line therapy for NSCLC patients with confirmed EGFR mutational status.
Several Phase 1 and 2 clinical trials have been completed, with over 600 NSCLC patients receiving treatment with abivertinib in China, the U.S., and Europe. We have recently submitted a new drug application (NDA) to the Chinese FDA and anticipate a positive recommendation for abivertinib as a treatment for NSCLC in China in the near future.
Abivertinib also have clinical utility as an inhibitor of Bruton’s tyrosine kinase (BTK) which impacts B cell proliferation and survival and is currently being investigated in clinical trials for B cell lymphoma. In addition, BTK places critical role in immune regulation and host inflammatory responses. Sorrento Therapeutics is conducting global trials of Abivertinib for patients hospitalized with Covid-19.
For more information about our completed and ongoing clinical trials, please visit www.clinicaltrials.gov.