On June 2, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported the latest data from the inaugural global pivotal study WU-KONG1 Part B (WU-KONG1B) of sunvozertinib in relapsed or refractory non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Dizal Pharma, JUN 2, 2024, View Source [SID1234643947]). The study demonstrated statistically significant outcomes on the primary endpoint for sunvozertinib and highlighted its significant clinical value to patients around the globe.

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As a rationally designed, oral, potent EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity, sunvozertinib was previously granted Breakthrough Therapy designations by both the US FDA and the China Center for Drug Evaluation (CDE) in treating NSCLC with EGFR exon20ins. Sunvozertinib has obtained conditional approval in China through a phase II pivotal study (WU-KONG6), making it the world’s first and only oral drug for the treatment of NSCLC patients with EGFR exon20ins.

WU-KONG1B, a multinational pivotal study, is the equivalent study with a similar design of WU-KONG6 to investigate sunvozertinib in relapsed or refractory NSCLC patients with EGFR exon20ins from 10 countries and regions in Asia, Europe, North America, and South America. The primary endpoint and key secondary endpoint were independent review committee (IRC) assessed objective response rate (ORR) and duration of response (DoR) respectively.

As of March 22, 2024, a total of 111 patients were enrolled to receive sunvozertinib treatment at 300mg as the optimal recommended phase 2 dose (RP2D). 107 patients who met the full analysis set (FAS) definition were included in efficacy analysis, of which Asian, White, and Black or African American enrollees were 57.9%, 40.2% and 1.9%, respectively. The key findings of the primary analysis were as follows:

Per IRC assessment, sunvozertinib achieved a best ORR of 53.3%.
The median DoR has not been reached, and the 9-month DoR rate was 57%, indicating durable efficacy of sunvozertinib.
Anti-tumor efficacy was observed regardless of amivantamab treatment. The best ORRs in patients with or without prior amivantamab treatment were 50% and 53.8%, respectively.
Sunvozertinib was well tolerated with a favorable safety profile consistent with previous reports.
"The WU-KONG1B study is significant in that it enrolled more than 40% of non-Asian patients. On a global scale, sunvozertinib demonstrated potent and durable anti-tumor efficacy with a best ORR of 53.3% and a 9-month DoR of 57% in relapsed or refractory NSCLC patients with EGFR exon20ins. The revelation of 3 patients (2.8%) achieving a confirmed complete response (CR) indicated deep tumor shrinkage with sunvozertinib treatment." said Prof. James Chih-Hsin Yang, MD, PhD at National Taiwan University Hospital and National Taiwan University Cancer Center, the leading principal investigator of WU-KONG1B. "Safety findings were similar to what has been previously reported in other sunvozertinib clinical studies. The majority of treatment-related adverse events (TEAEs) were reversible and clinically manageable. We look forward to more data readouts to validate the clinical benefit of sunvozertinib in EGFR Exon20ins NSCLC."

"It’s encouraging to see that the global pivotal study demonstrated statistically significant and clinically meaningful benefits of sunvozertinib as a single agent in NSCLC patients with EGFR exon20ins. Compared to what is available, sunvozertinib offers significant advantages as a single, oral drug: convenient, safe, and superior efficacies." said Xiaolin Zhang, PhD, CEO of Dizal.

He added, "In parallel, we are advancing the development of sunvozertinib in the first-line setting of NSCLC with EGFR exon20ins through a global phase III study (WU-KONG28). The accumulated clinical data for sunvozertinib has attracted lots of attention and facilitated our studies. We want to thank our patients and investigators for their hard work. We are committed to accelerate ongoing clinical studies and make the drug available to patients globally as soon as possible."

WU-KONG28, a phase III, multinational, randomized study, is ongoing to assess sunvozertinib versus platinum-based doublet chemotherapy in the first-line setting with patients from 14 countries and regions in Asia, Europe, North America, and South America.

About sunvozertinib (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 (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).