Eli Lilly's Non-Covalent BTK Inhibitor Pirtobrutinib (Jaypirca™) Accepted for Priority Review in China for Relapsed or Refractory Mantle Cell Lymphoma

JaypircaThe accelerated approval in the United States was primarily based on an open-label, single-arm, international phase 1/2 study (BRUIN trial).

Efficacy was evaluated in 120 patients with MCL who received Jaypirca 200 mg once daily until disease progression or unacceptable toxicity. The median number of prior lines of therapy was three (range: 1–9), with 93% of patients having received two or more prior lines of therapy; all patients had received one or more prior lines of therapy containing a covalent BTK inhibitor. Eighty-three percent of patients discontinued their last BTK inhibitor due to refractory or progressive disease.

Efficacy is as follows:

The full BRUIN study population (583 patients with malignant hematological tumors) In the safety analysis of Jaypirca 200mg taken once daily, the most common adverse reactions (ARs) with Jaypirca treatment were decreased neutrophil count, decreased hemoglobin, decreased platelet count, fatigue, musculoskeletal pain, decreased lymphocyte count, bruising, and diarrhea, occurring at a frequency of 20% or higher.

Jaypirca is a reversible (non-covalent), oral, highly selective BTK inhibitor that utilizes a novel binding mechanism. Jaypirca can re-establish BTK inhibition in MCL patients previously treated with covalent BTK inhibitors (ibrutinib, acalabrutinib, or zanubrutinib).

Jaypirca Mechanism of Action