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Phase I Study of DZD9008 in EGFR Exon 20 HER2 NSCLC

*September 2021*

DZD9008 is an orally bioavailable irreversible EGFR inhibitor being developed for EGFR and HER2 mutant NSCLC. This analysis is of the WU-KONG1 and WU-KONG2 trials and presented by Dr. Pasi Janne. Efficacy set included 56 patients (18 escalation, 38 expansion), all pretreated, 25 with prior EGFR TKI therapy, 7 patients with prior IO, 4 patients with prior amivantamab, and  23 patients with brain metastases.

Safety/Toxicity: Grade 3+ treatment‐related adverse event (TRAE) in 33% of patients with only 6% discontinuation rate for TRAE. Not a lot of granularity presented but footnote explains most TRAEs were diarrhea and rash, most grades 1 and 2.

Efficacy: Confirmed Response Rate (RR) of 38%. Impressive waterfall plot with efficacy seen across multiple subgroups: responses with prior amivantamab and with brain metastases though not in the 2 patients with prior poziotinib. Efficacy seen across different EGFR exon 20 mutations. Overall, DZD9008 shows encouraging activity in EGFR exon 20 NSCLC across different types of mutations with some durability noted.