Cullinan says zipalertinib plus chemotherapy meets PFS endpoint in Phase 3 REZILIENT3 lung cancer trial
CGEM•Safety and next steps
Safety in the zipalertinib arm was described as manageable, prompting the independent monitoring committee to recommend unblinding.
Full results have not been presented yet; they are slated for release at a future international medical conference.
Partners plan to pursue U.S. regulatory approval for the combination regimen in the first-line setting, pending FDA discussions.
Phase 3 trial met its primary endpoint
Cullinan Therapeutics announced a planned interim analysis of the Phase 3 REZILIENT3 trial met its primary progression-free survival endpoint.
Zipalertinib with platinum-based chemotherapy outperformed chemotherapy alone as first-line treatment for EGFR exon 20 insertion mutation non-small cell lung cancer.
