Dizal’s sunvozertinib shows promising results in global pivotal lung cancer study

Dizal, a prominent biopharmaceutical company listed on the Shanghai Stock Exchange (SSE:688192), has announced significant clinical results from its WU-KONG1 Part B (WU-KONG1B) study of sunvozertinib, showcasing substantial efficacy in treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins). The findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Sunvozertinib’s Global Impact on Lung Cancer

Sunvozertinib, a rationally designed, oral, potent EGFR inhibitor, demonstrated statistically significant outcomes on its primary endpoint, marking a significant clinical value to patients globally. This drug targets a wide spectrum of EGFR mutations with precision, sparing wild-type EGFR, which enhances its effectiveness while reducing typical side effects associated with EGFR treatments.

Previously granted Breakthrough Therapy designations by both the US FDA and China’s Center for Drug Evaluation (CDE), sunvozertinib has also received conditional approval in China through another pivotal phase II study (WU-KONG6), positioning it as the world’s first and only oral drug specifically for NSCLC patients with EGFR exon20ins.

Details from the WU-KONG1B Study

The multinational WU-KONG1B study enrolled patients from 10 countries across Asia, Europe, North America, and South America to investigate the efficacy of sunvozertinib in relapsed or refractory NSCLC cases. The primary endpoint was the objective response rate (ORR), assessed by an independent review committee, while the key secondary endpoint focused on the duration of response (DoR).

As of March 2024, a total of 111 patients were enrolled, receiving sunvozertinib at 300mg as the recommended phase 2 dose. The study achieved an impressive best ORR of 53.3%, with a median DoR not yet reached, suggesting durable efficacy. The 9-month DoR rate stood at 57%.

Clinical and Global Advancements

“The WU-KONG1B study is significant as it included a substantial proportion of non-Asian patients, demonstrating sunvozertinib’s potent and durable anti-tumor efficacy on a global scale,” noted Prof. James Chih-Hsin Yang, MD, PhD, the leading principal investigator from National Taiwan University Hospital and Cancer Center. “The safety findings were consistent with previous studies, with the majority of treatment-related adverse events being reversible and clinically manageable.”

Xiaolin Zhang, PhD, CEO of Dizal, commented on the broader implications: “It’s encouraging to see the global pivotal study demonstrating statistically significant and clinically meaningful benefits of sunvozertinib as a single agent in NSCLC patients with EGFR exon20ins. We are advancing the development of sunvozertinib in the first-line setting through a global phase III study (WU-KONG28), aiming to further validate its clinical benefits.”

The success of sunvozertinib in the WU-KONG1B trial represents a pivotal advancement in the treatment of NSCLC, particularly for patients with difficult-to-treat EGFR exon 20 insertion mutations. The ongoing studies and global trials highlight the potential for sunvozertinib to become a cornerstone therapy in oncology, offering new hope for patients with advanced lung cancer.