China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) and JAK1 inhibitor golidocitinib (DZD4205) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
Sunvozertinib: A Promising EGFR Inhibitor for NSCLC
Sunvozertinib, under development for the treatment of EGFR exon 20 insertion mutation non-small-cell lung cancer (NSCLC), was awarded priority review status in China in January this year. The latest results from the first China regulatory study (WU-KONG6) showed an objective response rate (ORR) of 60.8% among 97 patients with advanced NSCLC with EGFR Exon20ins mutant who had failed previous platinum-containing chemotherapy. Sunvozertinib demonstrated good anti-tumor activity across multiple EGFR Exon20ins mutation subtypes and in patients with treated and stable brain metastases.
Sunvozertinib in First-Line EGFR Exon20ins Mutant Advanced NSCLC
Based on the WU-KONG1A part and the WU-KONG15 summary analysis, the optimal ORR of sunvozertinib in first-line EGFR Exon20ins mutant advanced NSCLC at the recommended Phase II dosage (RP2D) (300mgQD) was as high as 77.8%.
Sunvozertinib in EGFR Mutant Advanced NSCLC with Failed EGFR-TKI Treatment
A summary analysis of WU-KONG1 Part A, WU-KONG2, and WU-KONG15 revealed that among 37 patients who had previously received a median of 5-line systemic treatment, the median progression-free survival (mPFS) as of April 3, 2023, was 5.8 months, and the median duration of remission (mDoR) was 6.5 months. The safety profile was consistent with previous reports.
Golidocitinib: Global, Multi-Center Regulatory Study in r/r PTCL
Among 88 patients who failed standard treatment, the ORR confirmed by the Independent Review Committee (IRC) was 44.3%, with 21 patients achieving complete response (CRR: 23.9%). The anti-tumor efficacy covered multiple common pathological subtypes of PTCL. The mDoR has not yet been reached, with a maximum DoR of 16.8 months. The longest treatment duration was 18 months, and the overall safety of golidocitinib was good.-Fineline Info & Tech
