Sunvozertinib Demonstrates Best-in-Class Potential as a First-Line Treatment for EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer Patients

• Sunvozertinib monotherapy demonstrated superior efficacy and excellent safety in patients in the 1st line setting for advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion (Exon20ins) mutations, achieving a confirmed objective response rate (cORR) of 78.6% 
• Anti-tumor efficacy of sunvozertinib was durable, as indicated by a median progression-free survival (PFS) of 12.4 months at the recommended phase II dose (RP2D) of 300mg
• Anti-tumor activity was observed across various subtypes of EGFR Exon20ins mutations.

SHANGHAI, Oct. 20, 2023 /PRNewswire/ -- Dizal today announced the latest research findings on the efficacy and safety of sunvozertinib in treatment-naïve patients with advanced or metastatic NSCLC with EGFR Exon20ins mutations at the 2023 European Society for Medical Oncology (ESMO) Congress.

The pooled analysis is based on the treatment-naïve NSCLC patients with EGFR Exon20ins mutations from the global multi-center phase I/II study (WU-KONG1) and the phase II study initiated by Chinese investigators (WU-KONG15). As of September 15, 2023, 28 patients were included in the efficacy analysis and 57 patients were included in the safety analysis.

The research findings revealed that among the 28 patients included in the efficacy analysis, 100% of them exhibited a reduction in target lesions. The confirmed objective response rate (cORR) by investigator assessment reached an impressive 78.6%. Notably, the 300mg cohort demonstrated a median progression-free survival (mPFS) of 12.4 months, surpassing previous research findings. Sunvozertinib showcased potent and durable anti-tumor efficacy, demonstrating favorable efficacy across various subtypes of EGFR Exon20ins mutations. These results highlight its potential as a leading treatment option for treatment-naïve NSCLC patients with EGFR Exon20ins mutations.

Additionally, sunvozertinib is well tolerated with overall safety profile consistent with previous reports in the later-line settings and similar to traditional EGFR-TKIs.

"Currently, there is a lack of targeted therapeutic drugs for first-line treatment of EGFR Exon20ins-mutated NSCLC, resulting in limited survival benefits for patients. However, significant advances have been made in research in this field in recent years. At this year's ESMO Congress, the results from the PAPILLON study were presented, evaluating the potential of Amivantamab in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic NSCLC with EGFR Exon 20ins mutations," said Xiaolin Zhang, PhD, Chairman and CEO of Dizal, "Moreover,  the latest research results from the pooled analysis of sunvozertinib provide further evidence to this therapeutic area and showcase its significant tumor response and clinically meaningful outcomes as a potential 'best-in-class' treatment. This is particularly exciting for us, and we eagerly anticipate the ongoing evaluation of efficacy and safety of sunvozertinib as a first-line treatment for NSCLC with EGFR Exon20ins mutations as compared to platinum-based doublet chemotherapy in the global multicenter, randomized phase III study (WU-KONG28). This study will offer new and effective treatment options in this realm."

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. As assessed by the Independent Review Committee (IRC), the primary endpoint of cORR at RP2D of 300mg QD 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 journal of Cancer Discovery (IF:39.397).

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. 

To learn more about Dizal, please visit www.dizalpharma.com, or follow us at Linkedin or Twitter.

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