Jaypirca breaks new ground in leukemia as confirmatory trial delivers strong results

While AbbVie, Johnson & Johnson, AZ, and BeiGene fight it out in the same BTKi market, Eli Lilly has decided to go its own way.

Jaypirca wins a second indication

In early December, the FDA approved Lilly's Jaypirca for CLL or SLL patients who have received at least two prior lines of therapy. It is positioned for patients who have already been treated with another BTKi or a BCL-2i.
• Its first indication, approved earlier this year, was for mantle cell lymphoma (MCL)
1.CLL: Chronic lymphocytic leukemia
2.SLL: Small lymphocytic lymphoma
3.BLC-2: B-cell lymphoma 2

Leveraging product traits to find a foothold

Jaypirca binds its target non-covalently, unlike the other products currently on the market (such as AbbVie and J&J's Imbruvica, AZ's Calquence, or BeiGene's Brukinsa), which form covalent bonds. That difference gives Jaypirca a distinct foothold in the market.

What results earned the indication?

Lilly secured accelerated approval for Jaypirca on the strength of the Phase 1/2 single-arm BRUIN trial, in which 108 subjects previously treated with both a BTKi and a BCL-2i achieved a response rate of 72%, with a median duration of response of 12.2 months. At last year's American Society of Hematology meeting, the same trial reported an ORR of 79% among BTKi/BCL-2i-experienced patients and 82.2% among BTKi-experienced patients.
• ORR: Overall response rate

Phase 3 results already submitted

Lilly says its Phase 3 trial, BRUIN CLL-321, has met its primary efficacy endpoint of PFS, and the results were submitted to the FDA in November. This Phase 3 trial evaluates Jaypirca in CLL/SLL patients previously treated with a BTKi, regardless of prior BCL-2i exposure, pitting Jaypirca against Gilead's PI3Ki Zydelig-rituximab or the bendamustine-rituximab combination.

• Another trial, BRUIN CLL-322, adds Jaypirca to Venclexta-rituximab in previously treated CLL/SLL, where prior therapy is not limited to a BTKi.

BRUIN CLL-313 compares Jaypirca against bendamustine-rituximab in treatment-naive CLL/SLL patients.

• Jake Van Naarden, CEO of Lilly's oncology unit, noted: "The main battleground for covalent BTKis is frontline CLL, while Jaypirca's core positioning is CLL patients already treated with a BTKi. That pie is still quite large, because most BTKis are not curative and other therapies need to be added."

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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