Dizal announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.

This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1). At 2023 ESMO, Dizal reported main study results, showing sunvozertinib as a single agent with confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months.

Sunvozertinib was previously granted  BTDs by both the US FDA and the China Center for Drug Evaluation (CDE) for relapsed or refractory patients  It was subsequently approved in China in 2023 for the treatment of patients who failed 1^st line treatment. NDA submissions for US and EU approvals in the same setting is anticipated later in 2024.

"We are delighted with the FDA's decision granting the Breakthrough Therapy Designation to sunvozertinib for first-line treatment, coming on the heels of earlier BTD approval in later lines of therapy — a clear indication of sunvozertinib's transformative potential in the treatment of patients with EGFR exon20ins NSCLC. Multiple clinical trials have consistently demonstrated sunvozertinib's significant clinical benefits to our patients. As a single, oral agent, it offers apparent advantages in both safety and patient compliance over chemotherapies and infusion." said Xiaolin Zhang, PhD, CEO of Dizal, "Now enrollment for the global pivotal study in relapsed and refractory setting (WU-KONG1 PART B) has been completed, and we are going to report the study results as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. A randomized global phase III study in the first line setting (WU-KONG28) is well underway. This new BTD will enable us work more closely with the FDA and accelerate its clinical development and regulatory submission."

Affecting roughly 2%-4% of NSCLC patients, EGFR Exon20ins mutations have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, 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.

Sunvozertinib's innovative molecular structure enables it to overcome the inherent difficulties of targeting EGFR Exon20ins mutations, offering improved efficacy, safety, and ease of administration. Supported by findings yielded in the multicenter phase 2 pivotal study WU-KONG6, sunvozertinib was approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy, validating its potent and well-tolerated profile in previously treated NSCLC patients with EGFR Exon20ins mutations.