Abstract 987P
Background
Sunvozertinib (DZD9008) is a rationally designed selective, irreversible EGFR inhibitor with wild-type EGFR selectivity. Several pivotal studies are ongoing for 2nd and 1st line treatment of NSCLC with EGFR exon20 insertion mutations (exon20ins). Here we reported preliminary results of WU-KONG6 (CTR20211009), the first pivotal study of sunvozertinib as a ≥ 2nd line treatment after platinum-containing chemotherapy.
Methods
WU-KONG6 is a phase 2, multi-center pivotal study in China in advanced NSCLC with EGFR exon20ins, whose diseases had progressed on or after platinum-based chemotherapy. The primary endpoint was ORR by Blinded Independent Central Review (BICR). Patients received 300 mg sunvozertinib once daily until discontinuation criteria were met. Data from the ongoing WU-KONG1 and WU-KONG2 studies were pooled with WU-KONG6 for the safety analysis.
Results
A total of 97 Chinese patients were enrolled between July 19, 2021 and May 6, 2022, and included in full analysis set (FAS). By July 31, 2022, the BICR evaluated confirmed ORR (cORR) was 59.8% (58/97). In patients with baseline brain metastasis, the cORR was 48.5% (16/33). Median DoR was not mature. Anti-tumor efficacy was observed across 30 different mutation subtypes. In a safety population of 277 patients, adverse events (AEs) resulting in permanent discontinuation of sunvozertinib was 6.1%. About 19.5% of patients required dose reduction due to AEs, with blood creatine phosphokinase increase as the most frequent cause (4.7%), followed by grade 3 diarrhea (4.0%).
Conclusions
The first pivotal study results confirmed sunvozertinib's superior anti-tumor efficacy. The safety profile from WU-KONG6 study was consistent with previously reported findings. A global multi-center pivotal study (NCT03974022) with the same study design is ongoing in Asia, Europe, Australia and US.
Clinical trial identification
NCT03974022.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.