Pharma Focus Asia

Dizal Unveils New Biomarker Analysis Data, Showcasing Sunvozertinib's Effectiveness for Treating Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Saturday, May 25, 2024

Dizal (SSE:688192), a biopharmaceutical company dedicated to developing innovative treatments for cancer and immunological diseases, has released new findings from a biomarker study focused on non-small cell lung cancer (NSCLC) patients with exon 20 insertion (exon20ins) mutations. The study highlights sunvozertinib as an effective treatment for this patient population. These findings are detailed in abstract #8563, available on the official website of the 2024 American Society of Clinical Oncology's (ASCO) Annual Meeting.

The study included 121 patients with EGFR exon20ins mutations who were treated with sunvozertinib. Serial plasma ctDNA samples were collected from baseline until disease progression (PD). Here are the key findings:

  • Sunvozertinib demonstrated anti-tumor efficacy regardless of baseline EGFR exon20ins status in plasma ctDNA.
  • A correlation was found between detectable EGFR exon20ins in baseline plasma ctDNA and a higher number of metastasis sites, including brain metastasis.
  • Patients with baseline negative EGFR exon20ins in plasma ctDNA had a higher objective response rate (ORR) and longer median progression-free survival (PFS) compared to those with positive EGFR exon20ins.
  • Sunvozertinib effectively reduced EGFR exon20ins in plasma ctDNA, indicating its direct effect on the EGFR pathway.
  • Most patients experienced a decrease in EGFR exon20ins mutant allele after sunvozertinib treatment, with clearance observed as early as one week into treatment.

Additionally, resistance to sunvozertinib may occur through EGFR-dependent and EGFR-independent mechanisms. Combining golidocitinib, a JAK1 inhibitor, with chemotherapy could be a potential strategy to overcome sunvozertinib resistance, as suggested by preclinical and clinical experiments.

Dr. Xiaolin Zhang, CEO of Dizal, emphasized the importance of this biomarker study in optimizing treatment for NSCLC patients with EGFR exon20ins mutations. Supported by positive outcomes from the WU-KONG6 study, sunvozertinib has been approved in China for relapsed or refractory NSCLC with EGFR exon20ins mutations. Additional data from the ongoing WU-KONG1 Part B study, encompassing patients worldwide, will be presented at the upcoming ASCO meeting, supporting regulatory submissions in various markets.

Sunvozertinib, discovered by Dizal scientists, is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with selectivity for wild-type EGFR. It has shown efficacy across various EGFR exon20ins subtypes and has a well-tolerated safety profile in clinical trials.

Two global pivotal studies, WU-KONG1 Part B (≥ 2nd line) and WU-KONG28 (1st line), are ongoing for NSCLC patients with EGFR exon20ins mutations.

Preclinical and clinical findings of sunvozertinib have been published in peer-reviewed journals such as Cancer Discovery and The Lancet Respiratory Medicine.



Cytiva - Supor Prime filtersMFA + MMA 2024CPHI China || PMEC China 2024Asia Healthcare Week 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference3rd World ADC Asia 2024