Multicenter phase 2 trial of sunvozertinib for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation

Sunvozertinib is an oral, irreversible, and selective TKI with favorable safety and antitumoractivity shown in phase 1 studies of heavily pretreated non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation (exon20ins). The phase 2 WU-KONG6 trial, at 37 centers in China, evaluated sunvozertinib monotherapy for locally advanced or metastatic (LA/M) NSCLC with exon20ins after at least one previous line of therapy including at least one line of platinum-based chemotherapy. Among 97 patients evaluable for efficacy, 59 patients had response, for an ORR of 61% (95% CI 50-71). All responses were partial. Responses were seen irrespective of age, sex, smoking history, EGFR exon20ins subtype, baseline brain metastasis, and previous lines of therapy. Sunvozertinib was well tolerated at 300 mg once daily. The authors conclude that sunvozertinib demonstrated antitumor efficacy in this patient population, with a manageable safety profile. A multinational phase 3 trial of sunvozertinib versus platinum-doublet chemotherapy for EGFR exon20ins NSCLC is ongoing.