Confirming Nuvation’s AnHeart takeover

Six months after taletrectinib’s owner, AnHeart, was taken over by Nuvation, the ALK/ROS1/NTRK inhibitor is to enter a phase 3 confirmatory study. Nuvation has promised to submit a US taletrectinib filing based on uncontrolled data this year, but tells ApexOnco that the pivotal trial is being initiated at the request of regulators in China, where taletrectinib is already awaiting approval for first and second-line NSCLC. Though the phase 3 study, a head-to-head against Xalkori aiming to enrol just 138 front-line, ROS1-positive NSCLC patients, is described as "international" it isn't thought to be necessary for US approval. Nuvation says the US filing will be backed by phase 2 data, and its expectation, based on the precedent of Bristol Myers Squibb's Augtyro, is that the Trust-I and II studies will suffice for full US approval. In Trust-II taletrectinib yielded a 92% ORR in 25 first-line patients; on a cross-trial basis that looks favourable versus the 66% ORR on Xalkori’s label, though the phase 3’s primary endpoint is PFS. Selected taletrectinib studies in ROS1-positive NSCLCSettingTrialDesign/dataNote1st-linePh3Vs Xalkori in 138 patients, PFS primary endpointStarts Sep 20241st-linePh2 Trust-II25 patients: ORR 92%, mPFS NR, 12mth PFS 82%To back US filing in 20242nd-linePh1 Trust-I65 patients: ORR 52%, mPFS 7.6mthBacks China filingSource: OncologyPipeline. This story has been updated to add comments from Nuvation.