Antitumor activity of sunvozertinib in NSCLC patients with EGFR Exon20 insertion mutations after platinum and anti-PD(L)1 treatment failures.

• DOI: 10.1200/jco.2022.40.16_suppl.9015
• Publication Date: 2022-06-06T18:04:22Z
• Authors: Pasi A. Janne; Mengzhao Wang; D. Ross Camidge; Paul Mitchell; Jian Fang; Weiqi Nian; Chao-Hua Chiu; Jianying Zhou; Yanqiu Zhao; Wu-Chou Su; Tsung-Ying Yang; Viola Weijia Zhu; Michael Millward; Yun Fan; Wen-Tsung Huang; Ying Cheng; Liyan Jiang; Daniel Brungs; Li Zheng; James Chih-Hsin Yang
• Keywords: 0301 basic medicine; 03 medical and health sciences; 3. Good health

9015 Background: Platinum-based chemotherapy is the 1 st line standard of care for NSCLC patients with EGFR exon 20 insertion mutations (Exon20ins), anti-PD(L)1 frequently used as well. Here we present anti-tumor activity sunvozertinib in these whose disease had progressed on therapies from two ongoing phase 1/2 studies (WK-KONG1, NCT03974022 and WU-KONG2, CTR20192097). Based data, was granted Breakthrough Therapy Designation by both US FDA China NMPA. Methods: The objective this study to characterize safety efficacy platinum-pretreated advanced harboring Exon20ins, or without anti-PD(L1) treatment. In addition, effect prior treatment sunvozertinib’s were explored. Results: As July 30, 2021, a total 52 locally metastatic Exon20ins post platinum enrolled into WU-KONG1 WU-KONG2 studies, included analysis set (dose range: 50 mg 400 mg, once daily). Male/Female: 21/31; Median age 59; Asian/White: 44/8; Prior therapies: median 2.5 (range 1-10); 31% received (all £ 300 cohorts); 40% subjects baseline brain metastasis. Partial response observed at ≥ 100 mg. At dose level 200 confirmed ORR 50% (1/2), 55.6 % (5/9), 44.8% (13/29) 22.2% (2/9), respectively. With follow-up time 10.5 months, DoR not reached cohort; 7 group 5.6 months. Progression free survival (PFS) rate 6 months cohorts 50%, 53.3%, 44.6% 44.4%, with/without treatment, comparable profiles observed. Conclusions: data suggest active irrespective after updated will be presented meeting. Sunvozertinib currently 2 pivotal clinical development (NCT03974022 CTR20211009). Clinical trial information: NCT03974022.