Parallel phase 1 clinical trials in the US and in China: accelerating the test of avitinib in lung cancer as a novel inhibitor selectively targeting mutated EGFR and overcoming T790M-induced resistance.

Avitinib, a new generation inhibitor of epidermal growth factor receptor (EGFR), was approved for clinical trial in both China and the United States, and the phase 1 trials were initiated in both countries in parallel. In the preclinical studies, avitinib showed three novel features including (1) irreversibly binding EGFR by forming a covalent bound with Cys 797 in the ATP-binding pocket, (2) sparing wild-type EGFR, and (3) overcoming T790M-induced resistance. Avitinib is the first China-developed novel EGFR inhibitor that has entered in global clinical trials, and will provide a precision targeted therapy for non-small cell lung cancer patients.