Jaypirca gets a front-line win

Not long after succeeding in BTK inhibitor-naive CLL in Bruin-314, Lilly’s non-covalent drug Jaypirca has claimed another pivotal win in early disease. On Monday the company toplined as positive the first-line Bruin-313 study, which tested Jaypirca against Rituxan plus bendamustine. Lilly said the improvement on the primary endpoint, progression-free survival, was “highly statistically significant and clinically meaningful”. There could be doubts about the comparator, given that targeted agents are moving into the front line. But Jaypirca has already matched AbbVie and Johnson & Johnson’s covalent BTK inhibitor Imbruvica in Bruin-314, which enrolled first and second-line BTK-naive patients. Lilly has previously told ApexOnco that its goal isn’t to “take out” other BTKs, with Jaypirca still likely to be mainly used following a covalent therapy like Imbruvica or BeOne’s Brukinsa. Jaypirca has FDA accelerated approval in third-line CLL; Lilly is planning a filing in earlier lines, backed by Bruin-313 and 314, set to begin later this year. One question is whether overall survival will be needed to complete an FDA submission – these data are currently immature, with a primary analysis not due until 2026. Lilly noted that the OS results were “trending strongly in favour of” Jaypirca.

Phase 3 trials of Jaypirca in CLL

Source: OncologyPipeline & clinicaltrials.gov.