Dizal Demonstrates Clinical Update for Sunvozertinib (DZD9008) in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 WCLC

On August 5, 2022 Dizal reported that positive clinical updates highlighting the therapeutic potential of sunvozertinib in non-small cell lung cancer (NSCLC) with epidermal growth factor receptor exon 20 insertion (EGFR Exon20ins) mutation at 2022 World Conference on Lung Cancer (WCLC) (Press release, Dizal Pharma, AUG 5, 2022, View Source [SID1234617713]).

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Lung cancer is the second most common cancer and leading cause of cancer death globally.1 NSCLC accounts for approximately 85% of all lung cancers. NSCLC patients with EGFR Exon20ins mutation lack effective treatment options.

Sunvozertinib, which was granted Breakthrough Therapy Designation by US FDA and China NMPA, is a rationally designed, oral, potent EGFR Exon20ins inhibitor, with wild-type EGFR selectivity. It is currently being evaluated in late-stage development of multiple global pivotal studies as ≥ 2nd line treatment after platinum-based chemotherapy and 1st line treatment for treatment-naïve patients.

Updated findings from the studies were presented at 2022 WCLC. As of April 30, 2022, in platinum-pretreated patients (n=119), the best ORR (at the RP2D of 300mg QD) assessment according to RECIST guidelines (version 1.1) was 52.4%. In patients with baseline brain metastasis, the best ORR at 300 mg QD reached 44%. The safety profile of sunvozertinib was amenable to long-term treatment. The most common drug related TEAE (treatment emergent adverse event) were diarrhea and rash, the majority of which were Grade 1/2 and clinically manageable.

"We are excited to share these updated findings to peer clinicians, researchers and scientists at WCLC." said Dr. Xiaolin Zhang, CEO of Dizal, "With its superior antitumor efficacy and favorable safety, we are confident that sunvozertinib has the potential to become a best-in-class treatment option for NSCLC patients harboring EGFR Exon20ins mutation with persisting unmet medical need."