Dizal Pharmaceutical Co., Ltd. announced the publication of the pre-clinical and early clinical data of sunvozertinib (DZD9008) for the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations in Cancer Discovery. Due to the unique structural features of EGFR exon20ins proteins, most approved EGFR TKIs are not active against them. Sunvozertinib (DZD9008) was designed with the goal to address the limitations of existing therapies.

It is an irreversible inhibitor targeting EGFR exon20ins as well as EGFR sensitizing, T790M and uncommon mutations while maintaining selectivity against wild-type EGFR. Sunvozertinib shows potent antitumor activity against EGFR exon20ins mutations at the enzymatic and cellular levels, and in patient-derived xenograft and transgenic animal models. These findings support the ongoing clinical development of sunvozertinib for the treatment of EGFR exon20ins NSCLC.

Based on the data, sunvozertinib has been granted Breakthrough Therapy Designation by US FDA and China CDE.