Taiho takes front-line zipalertinib into phase 3

A year after buying back full rights to the EGFR exon 20 inhibitor zipalertinib, the Otsuka subsidiary Taiho is embarking on a phase 3 trial, Rezilient-3. The study will be conducted in the first-line lung cancer setting, and will have two parts: a safety lead-in will determine the recommended dose of zipalertinib plus chemo, before a randomised portion compares the combo versus standard chemotherapy alone in around 300 patients. The primary endpoint is progression-free survival by independent review. The move follows phase 1/2 data presented at Asco 2022, and comes after Otsuka paid $275m to regain zipalertinib, then known as CLN-081, from Cullinan, an entity worth just $330m at the time. In November 2021 Blueprint had paid $250m for Lengo Therapeutics' rival preclinical EGFR exon 20 inhibitor LNG-451.