
Lilly’s Jaypirca bests Imbruvica

Lilly’s head-to-head trial of its non-covalent BTK inhibitor Jaypirca against J&J and AbbVie’s covalent drug Imbruvica was a bold move, and it looks to have paid off. On Tuesday Lilly said the Bruin CLL-314 study, in BTK inhibitor-naive CLL, had met its primary endpoint, showing non-inferiority on overall response rate, with nominal superiority. The key secondary progression-free survival endpoint was immature, but was trending in favour of Jaypirca, Lilly said. No overall survival detriment was seen. Full results will feature at a future medical meeting, with data in first versus second-line patients of particular interest. Lilly previously told ApexOnco that it still saw second-line disease, following a covalent BTK inhibitor, as the main market for Jaypira. But the group nevertheless plans a filing in earlier settings, once data from the first-line Bruin CLL-313 trial are available. Meanwhile, BTK degraders like BeOne’s BGB-16673 continue to advance, with that project being tested head-to-head against Jaypirca in second-line CLL. Lilly is also awaiting an FDA decision on Jaypirca’s full approval in second-line disease; while the confirmatory Bruin CLL-321 trial met its primary endpoint of progression-free survival, it failed to show an overall survival benefit versus standard of care.
Phase 3 trials of Jaypirca in CLL
Trial | Setting | Regimen | Primary endpoint | Note |
---|---|---|---|---|
Bruin CLL-321 | 2nd-line (covalent BTK-experienced; confirmatory trial) | Monotx, vs Zydelig/ bendamustine + Rituxan | PFS | Hit on PFS, missed on OS (but 76% crossover); awaiting FDA decision on full approval |
Bruin CLL-314 | BTK-naive (1st/2nd-line) | Monotx, vs Imbruvica | ORR | Toplined Jul 2025: met primary endpoint of non-inferiority; ORR favoured Jaypirca; PFS trending in favour of Jaypirca |
Bruin CLL-313 | 1st-line | Monotx, vs bendamustine + Rituxan | PFS | Data due “later in 2025”; filing to be based on ‘314 & ‘313 |
Bruin CLL-322 | 2nd-line | + Venclexta + Rituxan, vs Venclexta + Rituxan | PFS | Primary completion Apr 2026 |
Bruin CLL-18 (EU trial) | 1st-line | + Venclexta, vs Venclexa + Gazyva | PFS | Began Q2 2025 |
Source: OncologyPipeline & clinicaltrials.gov.
419