Dizal, a biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sunvozertinib. The application seeks approval 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) whose disease has progressed on or after platinum-based chemotherapy. This submission marks a significant step toward addressing the unmet medical needs of patients with this specific type of lung cancer.
The NDA is supported by data from the pivotal WU-KONG1 Part B study, a multinational trial evaluating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients across Asia, Europe, North America, and South America. The study's results, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated that sunvozertinib met its primary endpoint by achieving a statistically significant and clinically meaningful objective response rate (ORR), as assessed by an independent review committee (IRC), while maintaining a manageable safety profile.
Clinical Efficacy and Safety
Sunvozertinib has already received accelerated approval in China, making it the world's first and only oral drug approved 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 drug's innovatively designed molecular structure aims to provide enhanced efficacy, safety, and ease of administration compared to existing treatments.
Xiaolin Zhang, PhD, CEO of Dizal, stated, "We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC. 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."
Addressing Unmet Needs in NSCLC
Lung cancer remains the leading cause of cancer incidence and mortality worldwide, with NSCLC accounting for approximately 80%-85% of all lung cancers. Patients with NSCLC harboring EGFR exon20ins mutations are reported to have poorer prognoses compared to those with other EGFR sensitizing mutations. Sunvozertinib, as an irreversible EGFR inhibitor, targets a wide spectrum of EGFR mutations with wild-type EGFR selectivity.
Prior Clinical Data
In August 2023, sunvozertinib received approval from China's NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies, based on the results of the WU-KONG6 study. This pivotal study demonstrated a confirmed overall response rate (cORR) of 60.8% as assessed by the Independent Review Committee (IRC). Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, including in patients with pretreated and stable brain metastasis. Sunvozertinib has also shown encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.
Clinical trials have indicated that sunvozertinib has a well-tolerated and manageable safety profile, with most drug-related treatment-emergent adverse events (TEAEs) being 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.
