Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China is considering its drug candidate DZD9008 for breakthrough therapy status. The drug is designed to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received systemic treatment and carry an EGFR exon 20 insertion mutation. DZD9008, also known as Surufatinib, is a next-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) 。
EGFR exon20ins mutations are a rare and difficult-to-treat target in NSCLC, accounting for approximately 2%-4% of cases. These mutations are challenging due to their unique spatial conformation, diverse subtypes, and strong heterogeneity, which render traditional EGFR TKIs largely ineffective against this target. The median progression-free survival (mPFS) and median overall survival (mOS) for patients with EGFR exon20ins mutations are less than half of those with EGFR-sensitive mutations in advanced NSCLC. For over two decades, there has been a lack of safe and effective targeted treatments for EGFR exon20ins mutation NSCLC 。
Surufatinib is an orally administered, irreversible, highly selective EGFR tyrosine kinase inhibitor (TKI) that targets various EGFR mutation subtypes. It received priority review and approval from the China National Medical Products Administration (NMPA) in August 2023 for its first indication, making it the first drug in China to be approved for patients with locally advanced or metastatic NSCLC who have confirmed EGFR exon 20 insertion mutations after previous platinum-based chemotherapy or are intolerant to such treatment 。
In April 2024, Surufatinib was granted breakthrough therapy designation by the FDA for the first-line treatment of EGFR exon20ins NSCLC. This designation is based on the results of a Phase 1/2, open-label, international multicenter clinical study called “WU-KONG1” 。At the 2023 ESMO Congress, Dizal Pharmaceutical announced that the confirmed objective response rate (cORR) of Surufatinib monotherapy as a first-line treatment for EGFR exon20ins mutation-positive advanced NSCLC reached 78.6%, with a median progression-free survival (mPFS) of 12.4 months in the Phase 2 recommended dose (RP2D) 300mg group, demonstrating the potential for “high efficacy and low toxicity” in treatment. – Flcube.com
