Sunvozertinib, as a single agent, demonstrated promising antitumor activity and favorable safety profile in heavily pretreated patients with EGFR-mutated NSCLC who had developed resistance to EGFR TKI treatment

SHANGHAI, Dec. 11, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today the publication of a pooled analysis evaluating sunvozertinib in epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI)-resistant non-small cell lung cancer (NSCLC) in the official journal of the European Society for Medical Oncology (ESMO) Lung Cancer. The results of the analysis demonstrated that sunvozertinib exhibited promising antitumor activity and favorable safety profile, warranting future investigations into its potential in patients with EGFR mutated NSCLC who have developed resistance to EGFR TKIs.

The analysis pooled data from three Phase 1 and 2 studies (WU-KONG1, WU-KONG2 and WU-KONG15). A total of 40 NSCLC patients with EGFR sensitizing mutations who had developed resistance to EGFR TKI treatment were enrolled, 90% of whom had received ≥ 3 prior lines of therapy. Eligible patients received sunvozertinib at doses ranging from 50 mg to 400 mg once daily. As of September 15, 2023, the key findings of the analysis were as follows:

• The best objective response rate (ORR) was 27.5 %, and disease control rate (DCR) was 60 %.
• The median duration of response (mDoR) and progression free survival (mPFS) were 6.5 months and 6 months, respectively.
• Greater ORR of 55.6% was seen in patients with EGFR sensitizing and T790M double mutations (78% had received third-generation EGFR-TKI treatment in prior lines of therapy).
• Sunvozertinib was well-tolerated, and the safety profile was consistent with previous reports.

"Resistance to chemotherapy or EGFR TKIs remains a major challenge in the management of EGFR mutated NSCLC. In clinical practice, EGFR-targeted therapeutic strategies are one of the main approaches to addressing EGFR-TKI resistance," said Mengzhao Wang, MD, PhD, at Peking Union Medical College Hospital, the first and corresponding author of the paper. "Sunvozertinib is an oral, irreversible EGFR TKI that targets a broad spectrum of EGFR mutations while maintaining high selectivity for wild-type EGFR. Previous studies suggested that sunvozertinib demonstrated anti-tumor activity in NSCLC patients with EGFR-sensitizing mutations, T790M mutations, and exon 20 insertion mutations. This new analysis further validated sunvozertinib's potential in overcoming resistance to prior EGFR TKI treatments, warranting further investigation."

"Encouragingly, the pooled analysis has revealed the potential clinical value of sunvozertinib in EGFR TKI-resistant NSCLC," said Xiaolin Zhang, PhD, CEO of Dizal. "Confronted with the challenge of resistance to third-generation EGFR TKIs, we will continue to advance our exploration in this area, aiming to bring new treatment options to patients with EGFR mutated NSCLC."

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 to treat advanced NSCLC with EGFR exon20ins 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. The primary endpoint of the study 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.

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.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.

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 worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies, both of which have already been launched in China.

To learn more about Dizal, please visit , or follow us on Linkedin or Twitter.

Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions.

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect.

Contacts
Investor Relations: [email protected]
Business Development: [email protected]
Media Contact: [email protected]

SOURCE Dizal Pharmaceutical