Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new medicines for the treatment of cancer and immunological diseases, announced today 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) Annual Meeting on May 31 through June 4 in Chicago.

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 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.