Glossary:
Objective response rate: patients who respond partially or completely to treatment.
Duration of response: how long a patient responds to treatment.
Complete response: the disappearance of cancer.
News
Article
FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC
Key Takeaways
- Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression.
- The WU-KONG1 Part B study showed a 53.3% objective response rate and 57% nine-month duration of response for sunvozertinib.
The Food and Drug Administration has accepted and granted priority review to a new drug application for sunvozertinib.
The FDA has granted priority review to a new drug application for sunvozertinib, a treatment for patients with NSCLC with a specific genetic mutation.
The Food and Drug Administration has accepted and granted priority review to a new drug application for sunvozertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) whose disease has progressed on or after platinum-based chemotherapy.
The acceptance of the application and granting of priority review was announced in a news release issued by biopharmaceutical company Dizal, the manufacturer of sunvozertinib.
Efficacy and safety of sunvozertinib were established in the WU-KONG1 Part B study, findings from which were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Dizal previously announced that in the WU-KONG1 Part B study, sunvozertinib exhibited a best objective response rate of 53.3%, and a nine-month duration of response rate of 57%.
“On a global scale, sunvozertinib demonstrated potent and durable anti-tumor efficacy. … The revelation of three patients (2.8%) achieving a confirmed complete response (CR) indicated deep tumor shrinkage with sunvozertinib treatment," said Dr. James Chih-Hsin Yang at National Taiwan University Hospital and National Taiwan University Cancer Center, the leading principal investigator of WU-KONG1B, in a news release issued by Dizal at the time. "Safety findings were similar to what has been previously reported in other sunvozertinib clinical studies. The majority of treatment-related [side effects] were reversible and clinically manageable. We look forward to more data readouts to validate the clinical benefit of sunvozertinib in EGFR Exon20ins NSCLC."
A priority review designation means that the goal of the FDA is to act on an application within six months, as opposed to 10 months under standard review, and a priority review designation “will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications,” according to the FDA’s website.
“Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options,” said Xiaolin Zhang, CEO of Dizal, in the news release announcing the acceptance of the new drug application and granting of priority review. “Sunvozertinib’s priority review designation marks an important regulatory milestone in Dizal’s efforts to address unmet medical needs worldwide. The results from the WU-KONG1 Part B study are promising. If approved, sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins.”
Sunvozertinib, according to the National Cancer Institute, is an oral drug that binds to and inhibits the EGFR and human epidermal growth factor receptor 2 (HER2) proteins, potentially resulting in the inhibition of tumor growth and angiogenesis, or the creation of new blood vessels, and the regression of EGFR and HER-2-expressing tumors.
While sunvozertinib is being studied as a second line or later treatment in the WU-KONG 1 Part B trial, it is also being evaluated in the first-line setting in the currently active phase 3 WU-KONG28 trial.
WU-KONG28, which is currently recruiting patients, is set to enroll approximately 320 patients in order to compare sunvozertinib versus platinum-based doublet chemotherapy among participants with locally advanced or metastatic NSCLC with EGFR exon20ins mutation who are newly diagnosed or who have not received prior systemic therapy in advanced stage, according to the trial’s listing on clinicaltrials.gov.
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