The newest BTK inhibitor on the market, Eli Lilly’s Jaypirca, has shown its chops in a head-to-head battle against the oldest treatment in the class, AbbVie and Johnson & Johnson’s Imbruvica.
A phase 3 trial of Jaypirca has met its primary endpoint in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were newly diagnosed or had never received BTK inhibitors.
Lilly’s drug hit its mark, demonstrating that it matched up to Imbruvica in overall response rate (ORR) for both subpopulations in the study. The comparison also showed a nominal superiority for Jaypirca, although this analysis was not part of the trial's statistical plan.
Data for progression-free survival (PFS) were not mature, but Lilly said they were trending in favor of Jaypirca. The trial, coded Bruin CLL-314, will undergo a formal PFS analysis with the goal of showing superiority in the future, the company added.
“We launched the [Jaypirca] randomized development program with an ambitious suite of clinical trials, including head-to-head studies against modern standards of care and examinations of patient populations that reflect real world use, such as BTK inhibitor-pretreated patients,” Jacob Van Naarden, Lilly’s oncology chief, said in a statement.
Jaypirca’s overall safety profile remained consistent with previously reported trials, and no detriment to patients' life expectancy was observed, according to Lilly. Detailed results from the study will be presented at a medical conference later this year, the company said.
The company is waiting for results from another trial of Jaypirca, coded Bruin CLL-313, in CLL/SLL patients to apply for global approvals in the indication. That study, which pits Jaypirca against chemoimmunotherapy in treatment-naïve patients and uses PFS as the primary endpoint, is expected to read out later this year.
In 2023, Jaypirca scored accelerated FDA nods to treat CLL, SLL and mantle cell lymphoma after at least two prior lines of therapy, including one with another BTK inhibitor.
Jaypirca is unique in that it is a non-covalent, or reversible, BTK inhibitor, which can be used after treatment with the other three options in the class. Those BTKs—Imbruvica, AstraZeneca’s Calquence and BeOne Medicines' Brukinsa—are covalent and can’t be use sequentially.
Jaypirca generated sales of $337 million in 2024, compared to $3.1 billion for Calquence, which reached the market in 2017, and $2.6 billion for Brukinsa, which was approved in 2019. Imbruvica, which scored its original FDA nod in 2013, generated $6.4 billion last year. Its sales peaked in 2021 at $9.8 billion.