Found 1 Presentation For Request "987P"
987P - Sunvozertinib in NSCLC patients with EGFR exon 20 insertion mutations
- Mengzhao Wang (Beijing, China)
Abstract
Background
DZD9008 (sunvozertinib) is a rationally designed selective, irreversible EGFR inhibitor targeting EGFR mutations and with wild type EGFR selectivity. Results from the ongoing phase I/II studies showed promising anti-tumor activity of sunvozertinib in NSCLC patients with EGFR exon20 insertion mutation (exon20ins) and benign safety profile. Based on these data, sunvozertinib was granted the Breakthrough Therapy Designation by both US FDA and China NMPA. Here we analyzed the effect of prior therapies on safety and efficacy of sunvozertinib.
Methods
Data from the ongoing WK-KONG1 (NCT03974022) and WU-KONG2 (CTR20192097) studies were pooled together for the analysis. The results of anti-tumor efficacy were compared between those assessed by investigators and independent review committee (IRC). Retrospective analysis of EGFR exon20ins in tumor tissue was conducted in central laboratory. The relationship between prior treatment and sunvozertinib’s safety and efficacy was analyzed.
Results
As of July 30, 2021, a total of 110 NSCLC patients with EGFR or HER2 mutations were enrolled into WU-KONG1 and WU-KONG2 studies, among whom 56 carried EGFR exon20ins. In efficacy analysis set, patients received 1 to10 lines of prior treatment, including platinum-based chemotherapy (52, 92.9%), EGFR TKIs (25, 44.6%), PD(L)-1 (17, 30.4%), and others. Partial response was observed from the dose level of 100 mg to 400 mg (MTD dose). There was a high concordance rate between objective response rate (ORR) assessed by investigators and IRC. There was also a high concordance rate between EGFR exon20ins status in tumor tissue assessed by local and central laboratory. Anti-tumor activity was observed in patients with different categories of prior treatment. Prior platinum-based chemotherapy, EGFR TKIs or PD(L)-1 treatment did not impact the safety profiles of sunvozertinib.
Conclusions
The data suggest sunvozertinib is active in NSCLC with EGFR exon20ins, irrespective of different types of prior treatment. The updated data will be presented at the meeting. Sunvozertinib is currently in phase II pivotal clinical development (NCT03974022 and China CTR20211009).
Clinical trial identification
NCT03974022.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.