Clinical Trials Arena

Eli Lilly eyes SoC status as Jaypirca proves superior to Imbruvica in CLL/SLL

Jaypirca met its non-inferiority primary endpoint, trumping Imbruvica in patient overall response rate (ORR).

Eli Lilly’s Jaypirca (pirtobrutinib) has been shown to be superior to Johnson & Johnson (J&J) and AbbVie’s star Bruton's tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) in chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).

Conducted in treatment-naïve patients with CLL and SLL, the first-ever head-to-head trial found that Lilly’s oral therapeutic provokes a better overall response rate (ORR) in patients compared with Imbruvica.

Topline results from the Phase III BRUIN CLL-314 (NCT05254743) trial do not yet include progression-free survival (PFS) as the value is not yet mature. However, preliminary trends suggest that the non-covalent BTK inhibitor can also extend PFS for patients in both indications.

This builds on the positive results of the Phase III BRUIN CLL-321 trial (NCT04666038), which found that Jaypirca can reduce the risk of disease progression or death by 46% compared with Gilead’s Zydelig (idelalisib) plus Biogen and Genentech’s Rituxan (rituximab), and Teva Pharmaceuticals’ Treanda (bendamustine) plus Rituxan.

Jayprica poised to become SoC

BTK inhibitors are a highly popular option for the treatment of B-cell malignancies such as CLL and SLL, with many physicians using them in the first-line setting.

At the forefront of this drug class is Imbruvica, which raked in sales of $3.35bn in 2024 alone, according to AbbVie’s 2024 financial report.

However, a report from GlobalData, the parent company of Clinical Trials Arena, forecasts that Jaypirca is likely to become the BTK inhibitor market leader for CLL, with the therapy projected to make $5bn by 2032 — holding a 60% market share.

The positive topline results of the BRUIN CLL-314 trial could also result in Jaypirca being considered as standard of care (SoC) in CLL and SLL, further enhancing the therapy’s potential in this competitive market.

Lilly’s executive vice-president Jacob Van Naarden stated: “The positive topline results of this Phase III study will help us to build evidence supporting the potential role of Jaypirca in patients with CLL and SLL — hopefully enabling future regulatory approvals that allow physicians to use the medicine in various disease settings.”