Shanghai-based biopharmaceutical company Dizal has published new pivotal Phase II trial data on sunvozertinib in non-small-cell lung cancer (NSCLC) patients after receiving platinum-based chemotherapies. 

The single-arm, multi-centre Phase II WU-KONG6 study (NCT05712902) evaluated the safety, efficacy, and pharmacokinetics of sunvozertinib in 104 NSCLC patients with EGFR exon 20 insertion mutations (exon20ins).  

Results from the study were published in The Lancet Respiratory Medicine. As of the data cut-off on 3 April 2023, the blinded independent central review-assessed confirmed objective response rate (cORR) was 60.8%, meeting the trial’s primary endpoint.  

The median progression-free survival was 6.5 months. While 12-month overall survival (OS) was 64.9%, the OS data was immature.  

In the announcement accompanying the data, 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.” 

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By GlobalData

Sunvozertinib, marketed as Zegfrovy, is a small molecule irreversible EGFR inhibitor designed to target a range of EGFR mutations with wild-type EGFR selectivity. The drug candidate gained approval from China’s National Medicines Products Administration (NMPA) in August 2023 based on data from the WU-KONG6 study.  

Other marketed drugs in the NSCLC space include AstraZeneca’s EGFR inhibitor Tagrisso, which gained approval from the US Food and Drug Administration in 2015. The drug is approved in 94 countries for the treatment of patients with early-stage EGFR-mutated (EGFRm) NSCLC and in 99 countries for the first and second line of treatment of advanced EGFRm NSCLC.  

Tagrisso generated $5.4bn last year, as per AstraZeneca’s 2022 financial report. According to GlobalData’s Pharma Intelligence Center, Tagrisso is forecasted to generate $8bn in sales in 2029. 

GlobalData is the parent company of Clinical Trials Arena.  

Dizal has several other candidates in the pipeline such as DZD-8586, a small molecule drug indicated for the treatment of several different cancers including non-Hodgkin lymphoma, B-cell non-Hodgkin lymphoma, and chronic lymphocytic leukaemia (CLL).  

The candidate is currently being investigated in an open-label, randomised Phase I/II study (NCT05844956), which is evaluating the safety, tolerability, and pharmacokinetics of DZD-8586 in 386 patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The trial is expected to be completed in October 2027, as per ClinicalTrials.gov registry