Sunvozertinib Granted Breakthrough Therapy Designation by China CDE for First-Line Treatment of Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutation

Fourth Breakthrough Therapy Designation for sunvozertinib in NSCLC with EGFR exon20ins

SHANGHAI, October 13, 2024 /PRNewswire/ — Dizal (SSE (LON:):688192), a biopharmaceutical company committed to developing new medicines for the treatment of cancer and immunological diseases, announced that Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to sunvozertinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who had not received prior systemic therapy.

This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. It follows the grant by US Food and Drug Administration (FDA) for the first line setting in April this year. Sunvozertinib was previously given BTDs by both the ACE FDA and China CDE for relapsed or refractory patients.

BTD procedures in the US and China designed to accelerate the development and regulatory review of new drugs intended to treat serious or life-threatening conditions with early clinical evidence showing substantial improvement over available therapies. Drug candidates with BTD may be considered a review priority when submitting a New Drug Application (NDA).

“A total of four Breakthrough Therapy Designations by these two ACE and Chinese regulatory agency, not only reflects the transformative potential of sunvozertinib in EGFR exon20ins NSCLC, but also Dizal’s commitment to developing innovative new medicines to address unmet medical needs globally. Xiaolin ZhangPhD, CEO Dizal, “Sunvozertinib is the first and only oral drug approved for the treatment of lung cancer patients with EGFR exon20ins. rapidly.”

CDE provides BTD based on the results of a combined analysis of a global multi-center phase I/II study (WU-KONG1) and a phase II study (WU-KONG15) focusing on patients from China. The results of the study showed that sunvozertinib, as a single oral agent, produced a confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months in treatment-naïve patients with advanced or metastatic disease. NSCLC with EGFR exon20ins. In addition, sunvozertinib is well tolerated with an overall safety profile similar to classical EGFR-TKIs.

Currently, sunvozertinib is being evaluated in the WU-KONG28 study, a phase III, multinational, randomized study to compare sunvozertinib vs. platinum doublet chemotherapy in the treatment of global naïve patients.

NSCLC with EGFR exon20ins is difficult to treat because of its unique spatial conformation, diverse mutational subtypes, and high heterogeneity. In some parts of the world, antibodies with platinum containing chemotherapies are the only treatment options in the first line setting.

Sunvozertinib was approved in China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins in 2023 based on the results of the WU-KONG6 study. In an oral presentation in 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Dizal announced the results of the WU-KONG1 Part B study, a multinational study with patients from Asian, Europe, North Americaand South America. The study met its endpoint. Regulatory submissions for market approval are ongoing.

References
(1) Yan Xuetc. 2023ASCO Abstract#9073.
(2) Bazhenova L, et al. Lung Cancer. 2021 December, 162154-161.
(3) James Chih-Hsin Yang, et al. 2024 ASCO #8513.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists that targets a broad spectrum of EGFR mutations with wild-type EGFR selectivity. At August 2023sunvozertinib received approval from the NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of the WU-KONG6 study, a 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) assessed by the Independent Review Committee (IRC) reaching 60.8%. Anti-tumor efficacy was observed in different subtypes of EGFR exon20ins, and in patients with previously treated and stable brain metastases. In addition, sunvozertinib also showed promising anti-tumor activity in NSCLC patients with EGFR sensitization, 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 (emergence adverse events) are 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), in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib are published in peer-reviewed journals Cancer Discovery (NASDAQ: (YEN: 39,397) and Lancet Respiratory Medicine (If: 76.2).

About Diesel

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-class and innovative new medicines, and further address unmet medical needs around the world. Deeply rooted in translational science and molecular design, it has created an internationally competitive portfolio with two key assets in global pivotal studies, both of which have been launched in China.

To learn more about Dizal, visit www.dizalpharma.comor follow us on Linkedin or Twitter.

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