Global pharma major Eli Lilly has reported positive topline results from its Phase 3 BRUIN CLL-322 trial evaluating Jaypirca (pirtobrutinib) combo for patients with blood cancer.

 

The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) when Jaypirca was added to the venetoclax–rituximab regimen, as assessed by an independent review committee. 

 

Benefits were consistent across all key subgroups, including patients previously treated with covalent BTK inhibitors.

 

Overall survival data remain immature, but are trending in favor of the triple-combination arm. Safety results were broadly consistent across both treatment groups, with similar rates of adverse events and low discontinuation rates.

 

Treatment in both arms was time-limited to up to two years, after which patients received no CLL therapy until disease progression.

 

“BRUIN CLL-322 was an ambitious trial, building on an effective regimen, and these results outperformed our expectations,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. 

 

“Modern CLL treatment regimens provide such durable disease control that the vast majority of patients see their entire disease course managed by only one or two lines of therapy. For doctors and patients who prefer a time-limited approach, these BRUIN CLL-322 data demonstrate that the addition of Jaypirca could further extend the duration of benefit in second line CLL. 

 

"Together with the other Phase 3 data recently published from the BRUIN clinical program, these data reinforce the potential role that pirtobrutinib may have, whether as a time-limited combination as a second line treatment or as a continuously dosed monotherapy in either line of therapy.”