Eli Lilly’s Blood Cancer Drug Jaypirca Shows Promise in Trial as Early Treatment
Eli Lilly reported that its blood cancer therapy drug, Jaypirca, showed promise as a potential first-line treatment option by delaying disease progression in previously untreated patients.
Lilly’s new drug, Jaypirca (pirtobrutinib), treats blood cancers like chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Lilly said it plans to conduct further analysis next year of overall survival rates, another meaningful way of measuring a drug’s effectiveness.
The company has not released detailed results of its Phase 3 BRUIN CLL-313 clinical trial but said it will announce the results at a medical conference later in 2025.
However, Lilly said in the Phase 3 trial, Jaypirca outperformed chemoimmunotherapy, a type of cancer treatment that combines chemotherapy and immunotherapy. For chemoimmunotherapy, Lilly used bendamustine, a standard chemotherapy drug, with rituximab, a form of immunotherapy, to compare with Jaypirca.
The Phase 3 BRUIN CLL-313 involved 282 patients with CLL/SLL who were randomly chosen to receive Jaypirca or chemoimmunotherapy. The patients who took Jaypirca went longer without their cancer getting worse than those who received chemotherapy. This means Jaypirca was more effective at slowing down the disease. The company said in its news release that the results were the “most compelling” for this kind of medicine.
According to Lilly, Jaypirca “demonstrated a highly statistically significant and clinically meaningful improvement” in delaying the progression of cancer, which was the primary outcome of the trial.
In a news release, Jacob Van Naarden, executive vice president and president of Lilly Oncology, described the results as “striking and provocative,” and demonstrated the potential of Jaypirca to be a “meaningful treatment option for people with untreated CLL/SLL.”
Jaypirca is a Bruton tyrosine kinase (BTK) inhibitor, a class of drugs that target and block the activity of a BTK protein, which plays a role in the growth and survival of some cancer cells. Jaypirca is considered a “highly selective” inhibitor because it is specifically designed to target the BTK enzyme.
Jaypirca has received accelerated approval from the U.S. Food and Drug Administration for use in patients with CLL/SLL and mantle-cell lymphoma (a rare blood cancer) who have had at least two lines of therapy.
Van Naarden said with this study, the company continues “to build the clinical evidence supporting the possible role of pirtobrutinib in a variety of CLL/SLL treatment settings.”
The latest study follows encouraging results from Lilly’s Phase 3 BRUIN CLL-314 study, which compared Jaypirca to the cancer drug Imbruvica (ibrutinib) in patients with CLL/SLL. Imbruvica, AbbVie’s top-selling cancer drug, is a standard treatment for CLL. While both treatments target the BTK protein, Lilly said Jaypirca was shown to be more effective.
Lilly said that data from BRUIN CLL-313 and BRUIN CLL-314 have prompted the company to seek label expansion for Jaypirca as a first-line treatment option that can be given immediately after diagnosis.
“We look forward to presenting these data, as well as data from the recently announced positive BRUIN CLL-314 study, at upcoming medical meetings and preparing global regulatory submissions, with the goal of making pirtobrutinib an option for a wider group of patients who might benefit,” Van Naarden said in a news release.
Source Links:
https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-first-and-only-approved-non-0
https://www.reuters.com/business/healthcare-pharmaceuticals/lillys-blood-cancer-drug-shows-promise-trial-early-treatment-2025-09-08/
