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news.Dizal Pharmaceutical has obtained breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its sunvozertinib for the first-line treatment of individuals with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
Sunvozertinib already received BTDs for relapsed or refractory NSCLC patients in both the US and China. Credit: Michal Jarmoluk from Pixabay.
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This designation is based on results from the global multi-center Phase I/II study, WU-KONG1.
The BTD was awarded following the presentation of results at the 2023 ESMO conference, where sunvozertinib demonstrated a confirmed objective response rate (cORR) of 78.6% and 12.4 months median progression-free survival (mPFS) .
Sunvozertinib’s molecular structure is designed to effectively target EGFR Exon20ins mutations, which have been challenging to address with existing therapies.
The drug’s improved efficacy, safety, and ease of administration are supported by results from the multicenter Phase II pivotal study, WU-KONG6.
Sunvozertinib, also known as DZD9008, is an irreversible EGFR inhibitor that targets a broad spectrum of EGFR mutations with selectivity over wild-type EGFR.
The primary endpoint of the WU-KONG6 study, the confirmed overall response rate (cORR), reached 60.8%, as assessed by the Independent Review Committee (IRC).
Sunvozertinib has shown anti-tumour efficacy across various EGFR exon20ins subtypes and demonstrated activity in patients with stable brain metastases and other EGFR and HER2 mutations.
A randomised global phase III study is being carried out in the first line setting (WU-KONG28).
Dizal CEO Xiaolin Zhang said: “Multiple clinical trials have consistently demonstrated sunvozertinib’s significant clinical benefits to our patients. As a single, oral agent, it offers apparent advantages in both safety and patient compliance over chemotherapies and infusion.”
Earlier, Sunvozertinib received BTDs for relapsed or refractory NSCLC patients in both the US and China and was approved in China in 2023 for patients who failed first-line treatment.
Submissions for New Drug Applications (NDAs) in the US and EU are expected in 2024.
