Dizal's Sunvozertinib Pivotal Study Results Published in The Lancet Respiratory Medicine

SHANGHAI, Dec. 13, 2023 /PRNewswire/ -- Dizal today announced that the results of a phase 2 pivotal study of sunvozertinib for the treatment of platinum-pretreated non-small-cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins) (WU-KONG6) were published in the peer-reviewed journal The Lancet Respiratory Medicine (IF: 76.2). The publication of these research results further reinforces sunvozertinib's leading position as a potential best-in-class treatment option, following its selection for an oral presentation at this year's ASCO Annual Meeting.

Lung cancer is the leading type of cancer with the highest incidence and mortality rates in China. In NSCLC, EGFR represents the most common driver gene mutation, with exon20ins mutations being the most prevalent rare subtype, accounting for approximately 12% of all EGFR mutations. However, due to its unique spatial configuration and high heterogeneity, there has been a persistent lack of safe and effective targeted treatment options for this mutation, leading to limited survival benefits for patients.

Yun Fan, MD, PhD from the Department of Thoracic Oncology at the Cancer Hospital of the University of Chinese Academy of Sciences, and the first author of the paper, emphasized the significant challenge presented by EGFR exon20ins mutations in drug development. Despite various treatment modalities including chemotherapy, traditional EGFR-TKIs, immunotherapy and other targeted therapies, the objective response rate (ORR) in platinum-pretreated NSCLC patients with EGFR exon20ins mutations has not exceeded 50%.

Sunvozertinib is a selective EGFR TKI developed to target a wide spectrum of EGFR mutations. It is the first Chinese innovative drug approved for NSCLC patients with EGFR exon20ins mutations. The National Medical Products Administration (NMPA) granted approval based on the results from the WU-KONG6 study, a single-arm, multicenter phase 2 pivotal study, conducted to evaluate the antitumor efficacy of sunvozertinib in platinum-pretreated advanced stage NSCLC patients with EGFR exon20ins mutations. The study's primary endpoint, the independent review committee (IRC) -assessed ORR reached 61%, indicating a significant improvement over existing treatment options. With more than 100 different subtypes of EGFR exon20ins reported in NSCLC so far, thus making the treatment with a single agent even more challenging due to the diversified protein structure of different subtypes. However, owing to its unique chemical design and flexible compound, sunvozertinib was able to bind to different subtype proteins, and showed potent anti-tumor activities in cell lines expressing a broad variety of subtypes. More importantly, its activity was translatable to human. The ORRs were higher than 50% among different subtypes enrolled into this study. Additionally, the overall safety is similar to other EGFR TKIs and clinically manageable, which can be well managed in the clinic.

Mengzhao Wang, MD, PhD of the Department of Pulmonary Medicine at the Lung Cancer Center at Peking Union Medical College Hospital, and the first and corresponding author of the paper 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."

"Sunvozertinib marks the first approved innovative drug from Dizal. We are delighted to see the increasing recognition of sunvozertinib's potential as the best-in-class therapy for NSCLC patients with EGFR exon20ins mutations," said Xiaolin Zhang, PhD, Chairman and CEO of Dizal, "Dizal is expediting the global clinical research of sunvozertinib and eagerly anticipates collaborating with experts to explore additional treatment possibilities. Our goal is to deliver life-changing treatment options for patients worldwide."

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA for the treatment of advanced NSCLC with EGFR exon20ins mutations after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins mutations. The primary endpoint of the study, which was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins mutations.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug related TEAEs (treatment emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 PART B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins mutations.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).

About Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs around the world. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already launched. 

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