When AbbVie, Johnson, AZ, and BeiGene were fighting to the death on the same BTKi market, Eli Lilly decided to go its own way.
Jaypirca received a second indication
The FDA approved Eli Lilly Jaypirca in early December for patients with CLL or SLL who have already received at least two lines of therapy. It is marketed in patients who have already taken other BTKi or BCL-2i.
• The first indication was approved for Mantle cell lymphoma (MCL) earlier this year
1. CLL: Chronic lymphocytic leukemia
2. SLL: Small lymphocytic lymphoma
3.BLC-2: B-cell lymphoma 2
Use product characteristics to find a foundation
Jaypirca binds to the target through non-covalent bonds, unlike other products on the market today (such as AbbVie and Johnson’s Imbruvica, AZ’s Calquence, or BeiGene’s Brukinsa). This allowed Jaypirca to find a foothold in the market.
What results were used to obtain indications?
Eli Lilly obtained accelerated approval for Jaypirca through the Phase 1/2 single-arm trial BRUIN, with a total of 108 subjects who had not used BTKi and BCL-2i and a response rate of 72%; The median duration of response was 12.2 months. In the same trial last year, the American Society of Hematology announced the results of the BRUIN trial, which showed that the ORR of BTK/BCL-2i users was 79 and that of %、BTKi使用者達82.2%.
• ORR: Overall response rate
The results of the Phase 3 trial have been submitted
Eli Lilly claims that its Phase 3 trial, BRUIN CLL-321, has met the primary efficacy indicators for PFS and sent the results to the FDA in November. This Phase 3 trial is evaluating Jaypirca in patients with CLL/SLL who have been previously treated with BTKi, with or without BCL-2i, including a combination of Jaypirca, Gilead PI3Ki Zydelig-rituximab, or bendamustine-rituximab.
• Another trial, BRUIN CLL-322, in which Jaypirca was added to venclexta-ritusimab in treated CLL/SLL, not limited to BTKi.
BRUIN CLL-313 compares Jaypirca and bendamustine-rituximab in treatment-naïve patients with CLL/SLL.
• Jake Van Naarden, CEO of Eli Lilly Cancer, said, “The main battleground for covalent BTKi is on the front lines of CLL, and Jaypirca’s core positioning is on CLL patients who have been treated with BTKi. It’s quite big because most of the BTKi can’t be cured and need to be treated with other treatments.”
The content of this article has been authorized by Pharmaceutical Statistical Insights to PatientForce™ (Caihong Integrated Marketing Co., Ltd. / Unified Number: 27903403), all of which are jointly owned by PatientForce™ and Pharmaceutical Statistical Insights in accordance with the law.
References
- INDIANAPOLIS, July 6, 2023 ,PRNewswire, New England Journal of Medicine Publishes BRUIN Phase 1/2 Trial Data for Pirtobrutinib in BTK Inhibitor Pre-Treated Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Angus Liu, Lilly’s Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing, FIERCE Pharma, PHARMA
- INDIANAPOLIS, Dec. 1, 2023 ,PRNewswire, Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor
