On April 24, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new medicines for the treatment of cancer and immunological diseases, reported that two abstracts featuring the latest data on sunvozertinib in non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 through June 4 in Chicago (Press release, Dizal Pharma, APR 24, 2024, View Source [SID1234642312]).
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In a featured oral presentation, Dizal will highlight topline results from its WU-KONG1 Part B study. This multinational pivotal phase II trial, conducted across ten countries and regions, including the U.S., the EU, and China, investigates the efficacy and safety of sunvozertinib in patients with relapsed or refractory non-small cell lung cancer (NSCLC) harboring EGFR exon20ins mutations.
"We are very pleased that the inaugural global pivotal study of sunvozertinib is selected for oral presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting again" said Xiaolin Zhang, PhD, CEO of Dizal.
He added, "Last year, sunvozertinib was selected for oral presentation based on the results from WU-KONG6 study, a pivotal study in China. It was subsequently approved in China, making sunvozertinib the world first and only oral drug for the treatment of lung cancer patients with EGFR exon20ins mutations. WU-KONG1 Part B is the equivalent study with patients from Asia, Europe, North America, and South America. Preliminary analysis showed similar results to the WU-KONG6 study. With Breakthrough Therapy Designation, we are working closely with the US FDA, EMA and other regulatory agencies to accelerate its NDA submission."
Multiple clinical trials have consistently demonstrated the transformative potential of sunvozertinib as a single, oral agent to treat NSCLC patients with EGFR exon20ins mutations. A randomized, global phase III study (WU-KONG28), comparing sunvozertinib vs. platinum containing doublets, is ongoing in the first-line setting.
In addition to the oral presentation, one other abstract has been selected for a poster presentation. This poster will focus on plasma ctDNA biomarker analysis in patients with EGFR exon20ins NSCLC who have undergone treatment with sunvozertinib. The aim is to investigate the correlation between baseline EGFR exon20ins mutations and the anti-tumor effectiveness of sunvozertinib, along with potential strategies to address resistance to the drug.
Dizal presentation details during ASCO (Free ASCO Whitepaper) 2024
Lead Author
Abstract Title
Presentation Details
Prof. James Chih-Hsin Yang
A multinational pivotal study of sunvozertinib
in platinum pretreated non-small cell lung
cancer with EGFR exon 20 insertion mutations:
Primary analysis of WU-KONG1 study
Abstract #8513
Rapid Oral Abstract Session
Lung Cancer – Non-Small Cell Metastatic
June 1, 2024, 4:30 PM-6:00 PM CDT
S406
Prof. Mengzhao Wang
Plasma ctDNA biomarker study in patients with
non-small cell lung cancer with EGFR exon 20
insertion mutation treated with sunvozertinib
Abstract #8563
Poster Session
Lung Cancer – Non-Small Cell Metastatic
June 3, 2024, 1:30 PM-4:30 PM CDT
Hall A
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 mutations 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 mutations. 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 mutations.
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 mutations.
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).