Dizal has discovered sunvozertinib as a groundbreaking first-line treatment for individuals with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.
Sunvozertinib's unique molecular structure allows it to address the inherent challenges of targeting EGFR Exon20ins mutations, delivering enhanced efficacy, safety, and administration convenience.
Based on data from the multicenter phase 2 pivotal study WU-KONG6, sunvozertinib has received approval in China for the treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 20 insertion mutations and whose disease has advanced after receiving platinum-based chemotherapy.
This validation underscores its potent and well-tolerated profile in previously treated NSCLC patients with EGFR Exon20ins mutations, with sunvozertinib exhibiting a well-tolerated and manageable safety profile in clinical settings.
The approval is anchored in the results of the WU-KONG6 study, the pivotal investigation of sunvozertinib in NSCLC patients pretreated with platinum-based chemotherapy and carrying EGFR exon20ins mutations. The primary endpoint of the study, confirmed the overall response rate (cORR).
Significant anti-tumor efficacy was evident across various EGFR exon20ins subtypes, and notably, in patients with pretreated and stable brain metastasis.
Additionally, sunvozertinib exhibited promising anti-tumor activity in NSCLC patients with EGFR sensitizing mutations, T790M mutations, uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins mutations.
