Zipalertinib (CLN-081)

REZILIENT1 included 176 participants in its pivotal efficacy population and 244 in its safety population. Among 125 participants with prior platinum-based chemotherapy only, ORR was 40% and median DOR was 8.8 months. Two treatment-related deaths were reported in the safety population. In REZILIENT3, 279 participants were randomized. Median PFS was 14.5 months with Zipalertinib plus chemotherapy versus 8.5 months with chemotherapy, with a hazard ratio of 0.50. Grade ≥3 adverse events occurred in 87.1% versus 54.4%, respectively.