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