pLOG

2024-01-17

"Jaypirca" has made significant strides in the field of leukemia, with confirmation trial results yielding excellent outcomes.

When AbbVie, Johnson & Johnson, AstraZeneca, and BeiGene are engaged in fierce competition in the same BTKi market, Roche has decided to chart its own course.

Jaypirca obtains the second indication

The FDA approved Roche's Jaypirca in early December for use in patients with CLL or SLL who have received at least two prior lines of therapy. Its market positioning targets patients who have previously used other BTKi or BCL-2i. The first indication was approved earlier this year for Mantle Cell Lymphoma (MCL).

  1. CLL: Chronic Lymphocytic Leukemia
  2. SLL: Small Lymphocytic Lymphoma
  3. BCL-2: B-cell lymphoma 2

Establishing a foundation with product characteristics

Jaypirca differs from other products on the market, such as AbbVie and Johnson & Johnson's Imbruvica, AstraZeneca's Calquence, or BeiGene's Brukinsa, by using non-covalent binding and target binding rather than covalent binding. This allows Jaypirca to find a foothold in the market.

What results in obtaining the indication?

Roche obtained accelerated approval for Jaypirca through the Phase 1/2 BRUIN trial, with 108 participants who had not previously used BTKi or BCL-2i, achieving a response rate of 72%; median response duration reached 12.2 months. The same trial, presented at last year's American Society of Hematology, revealed an ORR of 79% for BTK/BCL-2i users and 82.2% for BTKi users.

  • ORR: Overall response rate

Results from Phase 3 trials have been submitted

Roche claims that its Phase 3 trial, BRUIN CLL-321, has achieved the primary efficacy endpoint of PFS and submitted the results to the FDA in November. This Phase 3 trial evaluates Jaypirca in CLL/SLL patients who have previously received BTKi treatment, with or without prior BCL-2i treatment, alongside other treatments such as Roche's Zydelig-rituximab or bendamustine-rituximab combination.

  • Another trial, BRUIN CLL-322, combines Jaypirca with Venclexta-rituximab in previously treated CLL/SLL patients, with prior treatment not limited to BTKi. BRUIN CLL-313 compares Jaypirca with bendamustine-rituximab in treatment-naive CLL/SLL patients.
  • Jake Van Naarden, CEO of Roche's Oncology Division, stated, "The main battleground for covalent BTKi is frontline CLL, while Jaypirca's core positioning is in CLL patients who have received prior BTKi treatment. The pie here is quite large because most BTKis cannot cure and require additional therapies."

 

 

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Reference


  • 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