Nuvation goes early with Ibtrozi

Nuvation, not content with getting one up on its rival Nuvalent with FDA approval of Ibtrozi in ROS1-positive NSCLC irrespective of therapy line, is now looking even earlier. Nuvation recently started a phase 3 trial of Ibtrozi (taletrectinib) as adjuvant therapy – an area that Nuvalent hasn’t ventured into. The Trust-IV study, recently listed on clinicaltrials.gov, will compare Ibtrozi versus placebo in ROS1-fusion positive stage IB, II and IIIA NSCLC who’ve undergone complete tumour resection, with a primary endpoint of disease-free survival. Nuvation already has a first-line trial under way, but this is for Chinese regulators; it won’t be needed for the FDA, which granted Ibtrozi a full green light in June, including in first-line disease. This was a blow to Nuvalent, which has started a rolling US submission for its contender, zidesamtinib, with completion set for the third quarter – but only in pretreated disease. First-line plans are vague, but Nuvalent says it is engaging with the FDA “on potential opportunities for line-agnostic expansion”. The company presented data from the pivotal Arros-1 trial of zidesamtinib at the recent World Lung meeting, but these were virtually identical to results released in June. Still, Nuvalent boasts a $5.7bn market cap, versus Nuvation’s $1.1bn.

Notable trials of Nuvation’s Ibtrozi in ROS1-positive NSCLC

Source: OncologyPipeline & clinicaltrials.gov.