Dizal Submits New Drug Application To The U.S. FDA For Sunvozertinib In Treating Relapsed Or Refractory Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

The submission is supported by data from the pivotal WU-KONG1 Part B study, which featured in an oral session at the 2024 ASCO Annual Meeting

Sunvozertinib is the world's first and only oral drug approved for NSCLC patients with EGFR exon20ins

SHANGHAI, Nov. 8, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases,
announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of
locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Previously, sunvozertinib received accelerated approval in China, making it the world's first and only oral drug for NSCLC patients with EGFR exon20ins. It has also been granted Breakthrough Therapy Designations (BTDs) by both the U.S. FDA and the China Center for Drug Evaluation (CDE) for treating EGFR exon20ins NSCLC.

The submission is supported by results from the WU-KONG1 Part B study, a multinational pivotal study investigating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients from Asia, Europe, North America, and South America. Sunvozertinib met the primary endpoint by demonstrating statistically significant and clinically meaningful objective response rate (ORR), as assessed by an independent review committee (IRC), while maintaining a manageable safety profile. Data from the study were presented in an oral session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

"We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC." said Xiaolin Zhang, PhD, CEO of Dizal. "The filing for approval of sunvozertinib marks Dizal's first NDA submission to the FDA, which represents an important step forward as we continue our efforts to address unmet medical needs globally. We look forward to working closely with the FDA on their review of our application."

Lung cancer is the leading cause of cancer incidence and mortality worldwide. NSCLC accounts for approximately 80%-85% of all lung cancers. Patients with NSCLC harboring EGFR exon20ins are
reported to have poorer prognosis than those with other EGFR sensitizing mutations.
Sunvozertinib, with its innovatively designed molecular structure, provides enhanced efficacy, safety, and ease of administration.

References:

About
s unvozertinib (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.

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