Dizal announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for sunvozertinib for the treatment of advanced NSCLC with EGFR exon20ins mutations after platinum-based chemotherapies. Sunvozertinib (DZD9008) is an investigational, best-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) exon20 insertion (exon20ins) mutations. Sunvozertinib has been granted Breakthrough Therapy Designation by both the US FDA and China CDE.

The NDA submission for sunvozertinib is based on data from the WU-KONG6 study, a multicenter, single-arm, Phase II pivotal study conducted in China to evaluate the efficacy and safety of sunvozertinib in platinum-pretreated NSCLC patients with EGFR exon20ins mutations. The primary objective of the study was Objective Response Rate according to RECIST v1.1, with Duration of Response (DOR) as the key secondary objective. As of July 31, 2022, the confirmed objective response (cORR), as assessed by blinded independent central review (BICR), was 59.8% .

The objective response rate for patients with baseline brain metastasis was 48.4%. Sunvozertinib showed superior safety profile. The most common drug related TEAEs (treatment emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Global pivotal studies of sunvozertinib in patients with advanced NSCLC with EGFR exon20ins in the 1st line and = 2nd line setting are ongoing.