Trial Data Opens Door for Earlier Use of Lilly’s BTK Inhibitor

(ORLANDO) – At an American Society of Hematology (ASH) meeting, the pharmaceutical company Eli Lillypresented results from a critical head-to-head study, comparing its drug Jaypirca (pirtobrutinib) against Imbruvica(ibrutinib) from AbbVie and Johnson & Johnson. Both medications are BTK inhibitors, indicated for leukemia and lymphoma.

Efficacy and Response Rates

The Bruin-CLL-314 trial examined Jaypirca versus Imbruvica in patients with chronic lymphocytic leukemia (CLL)or small lymphocytic lymphoma (SLL), spanning both treatment-naïve (first-line) and previously treated populations whose disease had progressed.

• In terms of response: The analysis demonstrated that Jaypirca met its primary objective of non-inferioritycompared to Imbruvica.

  • Across the total of 662 participants, 87% of patients on Jaypirca showed a response, compared to 79% of those on Imbruvica.

  • In the previously treated group (who had progressed/not responded to earlier therapy), the response rate for Jaypirca was 84%, exceeding Imbruvica’s 75%, which was statistically significant for non-inferiority.

  • Among the treatment-naïve participants, Jaypirca recipients had a 93% response rate versus 86% for Imbruvica; however, this difference was not deemed statistical proof of non-inferiority.

Safety and Disease Progression Benefits

• Disease Progression: An interim analysis indicated that Jaypirca shows signs of delaying disease progression or death (Progression-Free Survival). Specifically, the drug reduced the relative risk of these events by 43% in the broad population, with benefits being more pronounced in the treatment-naïve group.

• Safety Profile: While both drugs had similar rates of common side effects (like infections, anemia, gastrointestinal issues), Jaypirca was associated with lower rates of hypertension and irregular heartbeat. These particular side effects have historically impacted the uptake of Imbruvica.

Implications for Market Position

Jaypirca, which recently received conversion of its approval to a traditional nod for use earlier in the treatment landscape for patients who have progressed on a prior BTK inhibitor, is poised to challenge existing therapies.

• The data from the Bruin-CLL-314 trial strengthens Lilly’s argument to position the drug in the earlier lines of care.

• Researchers noted that Jaypirca’s favorable safety profile could particularly benefit older and more frail patients in the first-line setting. However, they also stated that continued, longer follow-up data will be necessary to fully confirm the benefits and determine which patient subgroups are most appropriate for initial treatment with Jaypirca.

Source: https://www-biopharmadive-com.translate.goog/news/ash-2025-lilly-jaypirca-imbruvica-leukemia-lymphoma/807232/?_x_tr_sl=en&_x_tr_tl=vi&_x_tr_hl=vi&_x_tr_pto=tc