Shanghai-based biopharmaceutical company, Dizal, has published new Pivotal Phase II Trial Data on sunvozertinib in non-small cell lung cancer (NSCLC). Sunvozertinib is an oral and selective tyrosine kinase inhibitor that has a favorable encouraging anti tumor activity, as shown in Phase 1 studies of patients with non-small cell lung cancer. It is discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity.
The results from this study were published in The Lancet Respiratory Medicine. WU-KONG6 is an open-label, multicentre Phase 2 trial of sunvozertinib monothetapy which was conducted across 37 medical centres in China. All patients had received at least one line of previous systemic therapy and at least one line containing platinum-based chemotherapy. This phase II study evaluated the safety, efficacy and pharmacokinetics of sunvozertinib in 104 patients. These NSCLC patients were with EGFR exon 20 insertion mutations.
In August 2023, sunvozertinib has received approval from NMPA (National Medical Products Administration) of China for treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum based chemotherapies.
In this latest announcement, the first author of the paper Dr Mengzhao Wang said: “Sunvozertinib, the first Category-I Innovative Drug approved for the treatment of EGFR exon20ins NSCLC in China, has demonstrated a superior efficacy, safety, and convenience profile. It overcomes the existing treatment challenges faced by advanced NSCLC patients with EGFR Exon20ins mutations, offering an effective treatment option for this patient population.”
The publication of these research results reinforces sunvozertinib’s leadjng position as a potential best-in-class treatment option. Though there are various treatment modalities such as chemotherapy, immunotherapy and other targeted therapies but the objective response rate in platinum-pretreated NSCLC patients with EGFR Exon20ins mutations has not exceeded even 50%. On the other hand, sunvozertinib is a selective EGFR TKI which is developed to target a wide spectrum of EGFR mutations. Also, it is the first Chinese innovative drug which is approved for NSCLC patients with EGFR Exon20ins mutations.
The information shared in this blog is for educational purposes only.
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