Eli Lilly’s fast-growing blood cancer drug Jaypirca could gain additional momentum thanks to a new trial suggesting it could move into the first-line setting.
Reversible BTK inhibitor Jaypirca (pirtobrutinib) has been shown in the BRUIN CLL-313 to significantly improve progression-free survival compared to standard chemoimmunotherapy (CIT) in previously untreated patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.
Overall survival (OS) data is not mature at the moment, but was trending in favour of Lilly’s drug even though it has not reached statistical significance. The company said the improvement over CIT with bendamustine plus rituximab is “one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study.”
Lilly broke new ground for the BTK inhibitor class in 2023 when it secured FDA approval for Jaypirca as a third-line treatment for CLL/SLL, as well as mantle cell lymphoma (MCL). It was specifically designed to work in patients who develop resistance mutations to current BTK inhibitors such as AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib), AstraZeneca’s Calquence (acalabrutinib), and BeiGene’s Brukinsa (zanubrutinib), which are already options for frontline treatment of CLL/SLL.
That profile has helped the drug make steady headway in the market, with sales coming in at $337 million last year and contributing $123 million in the second quarter of this year alone, with an 85% increase in total prescription numbers compared to the same period in 2024.
It has a long way to go before it can reach the heights of its rivals, given that Calquence had sales of more than $3.1 billion last year, while Imbruvica is in decline, but still made $3.4 billion, and ahead of fast-growing Brukinsa, which generated $2 billion.
The results of the BRUIN CLL-313 study will be combined with the earlier BRUIN CLL-314 trial – which found that Jaypirca was as effective as Imbruvica in previously untreated CLL/SLL – as part of a regulatory filing to expand the label for Jaypirca later this year.
“The results from BRUIN CLL-313 are striking and provocative, across both PFS and OS endpoints, further demonstrating the potential of pirtobrutinib to be a meaningful treatment option for people with untreated CLL/SLL,” said Jacob Van Naarden, head of Lilly Oncology.
“We continue to build the clinical evidence supporting the possible role of pirtobrutinib in a variety of CLL/SLL treatment settings, including treatment-naïve, BTK inhibitor-naïve, and BTK inhibitor-exposed,” he added.
