Amongst sufferers within the relapsed/refractory and treatment-naive settings with Bruton tyrosine kinase inhibitor–naive persistent lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), Jaypirca (pirtobrutinib) labored in addition to Imbruvica (ibrutinib) in shrinking or controlling most cancers, in accordance with up to date knowledge from the section 3 BRUIN CLL-314 trial.
On this direct comparability, the information additionally urged that sufferers taking Jaypirca confirmed a progression-free survival profit, Dr. Jennifer Woyach reported when presenting the findings on the 2025 American Society of Hematology Annual Assembly.
Within the intent-to-treat inhabitants of sufferers with both relapsed/refractory CLL or treatment-naive CLL, the general response charge was 87% in sufferers randomized to Jaypirca (331 sufferers) versus 78.5% in these randomized to Imbruvica (331 sufferers). The very best total response with Jaypirca versus Imbruvica, respectively, was full remission or full remission with incomplete hematologic restoration of 4.8% versus 2.4%, partial remission or nodular partial remission of 82.2% versus 76.1%, partial remission with lymphocytosis of two.4% versus 3.9%, secure illness of 5.4% versus 10.9%, and progressive illness of 1.5% versus 1.2%.
Within the treatment-naive inhabitants, the general response charge was 92.9% in sufferers randomized to Jaypirca (112 sufferers) versus 85.8% in these randomized to Imbruvica (113 sufferers). The very best total response with Jaypirca versus Imbruvica, respectively, was full remission or full remission with incomplete hematologic restoration of seven.1% versus 3.5%, partial remission or nodular partial remission of 85.7% versus 82.3%, partial remission with lymphocytosis of 0.9% versus 2.7%, secure illness of two.7% versus 4.4%, and no instances of progressive illness.
Within the relapsed/refractory inhabitants, the general response charge was 84% in sufferers randomized to Jaypirca (219 sufferers) versus 74.8% in these randomized to Imbruvica (218 sufferers). The very best total response with Jaypirca versus Imbruvica, respectively, was full remission or full remission with incomplete hematologic restoration of three.7% versus 1.8%, partial remission or nodular partial remission of 80.4% versus 72.9%, partial remission with lymphocytosis of three.2% versus 4.6%, secure illness of 6.8% versus 14.2%, and progressive illness of two.3% versus 1.8%.
Glossary
Intent-to-Deal with Inhabitants: all sufferers who have been assigned to a therapy group in a research, no matter whether or not they accomplished the therapy as deliberate.
General Response Charge (ORR): the share of sufferers whose most cancers shrinks or disappears throughout therapy.
Full Remission (CR): no indicators of most cancers will be discovered utilizing commonplace testing.
Full Remission With Incomplete Hematologic Restoration (CRi): most cancers can’t be detected, though blood counts haven’t absolutely returned to regular.
Partial Remission (PR): most cancers has shrunk however continues to be current.
Nodular Partial Remission (nPR): most cancers has shrunk, and a few irregular areas stay however are improved in contrast with earlier than therapy.
Partial Remission With Lymphocytosis (PR-L): most cancers has shrunk despite the fact that a brief enhance in sure white blood cells is seen.
Steady Illness (SD): most cancers has not grown considerably and has not shrunk sufficient to satisfy remission standards.
Progressive Illness (PD): most cancers has grown or unfold throughout therapy.
Development-Free Survival (PFS): the size of time a affected person lives with out the most cancers getting worse.
“Jaypirca demonstrated persistently greater total response charges than Imbruvica throughout all sufferers together with treatment-naive and relapsed/refractory populations,” mentioned Woyach, director of the Division of Hematology at The Ohio State College Complete Most cancers Middle.
Development-free survival knowledge, though immature, confirmed a development in favor of Jaypirca. Within the intent-to-treat inhabitants, at a median follow-up of twenty-two months with Jaypirca and 19.7 months with Imbruvica, the 18-month progression-free survival charges per investigator evaluation have been 86.9% versus 82.3%. Within the relapsed/refractory inhabitants, at a median follow-up of 18.4 months with Jaypirca and 15.8 months with Imbruvica, the investigator-assessed 18-month progression-free survival charges have been 81.7% versus 79.2%. Within the treatment-naive inhabitants, at a median follow-up of twenty-two.5 months with Jaypirca and 22.4 months with Imbruvica, the investigator-assessed 18-month progression-free survival charges have been 95.3% versus 87.6%.
“Early developments in progression-free survival favored Jaypirca amongst all sufferers and within the relapsed/refractory and treatment-naive populations,” mentioned Woyach, including that probably the most pronounced impact occurred within the treatment-naive inhabitants, which had the longest follow-up at this knowledge cutoff.
Understanding the Security of Jaypirca in CLL Therapy
Concerning security, the commonest all-grade treatment-emergent unintended effects with Jaypirca versus Imbruvica have been neutropenia (22.7% versus 17.8%), higher respiratory tract an infection (17.9% versus 19.4%), anemia (15.2% versus 14.2%), pneumonia (13.6% versus 15.1%), and diarrhea (13.3% versus 19.1%). The commonest grade 3 or greater treatment-emergent unintended effects with Jaypirca versus Imbruvica have been neutropenia (17.3% versus 13.2%), pneumonia (6.4% versus 8.6%), and anemia (5.8% versus 3.7%).
Charges of all-grade (10.6% versus 15.1%) and grade 3 or greater (3.3% versus 4.9%) hypertension have been decrease with Jaypirca versus Imbruvica. One affected person developed Richter transformation with Jaypirca versus 4 sufferers with Imbruvica.
“Jaypirca was nicely tolerated with fewer dose reductions and discontinuations resulting from treatment-emergent unintended effects than Imbruvica,” Woyach mentioned.
She famous that unintended effects of particular curiosity have been principally low-grade and in step with prior Jaypirca research. Grade 3 or greater neutropenia (25.2% versus 17.5%) and anemia (6.1% versus 3.7%) have been greater with Jaypirca versus Imbruvica; nevertheless, grade 3 or greater thrombocytopenia was decrease with Jaypirca (3.6% versus 4%).
All-grade atrial fibrillation or flutter (2.4% versus 13.5%) was considerably decrease with Jaypirca versus Imbruvica, significantly amongst sufferers aged 75 years or older (4.5% versus 21.4%).
Examine Design for the Part 3 BRUIN CLL-314 Trial and Affected person Traits
The section 3 BRUIN CLL research accrued sufferers with Bruton tyrosine kinase inhibitor–naive CLL/SLL, together with each treatment-naive and relapsed/refractory illness. General, 662 sufferers (intent-to-treat inhabitants) have been randomized to Jaypirca (331 sufferers) or Imbruvica (331 sufferers) between August 18 2022 and June 17 2024. The median age was 67 years in each arms and the median variety of prior therapies in each arms was 1. Within the intent-to-treat inhabitants, 225 sufferers have been treatment-naive and 437 sufferers have been relapsed/refractory.
In sufferers with evaluable samples, 68% (199 of 293 sufferers) versus 66% (183 of 277 sufferers) within the Jaypirca versus Imbruvica cohorts had unmutated IGHV. Moreover, 40% (104 of 259 sufferers) versus 34% (78 of 227 sufferers) and 15% (50 of 331 sufferers) versus 16% (52 of 331 sufferers) had advanced karyotype with 3 or extra abnormalities and del(17p), respectively.
Jaypirca was administered orally at 200 mg each day and Imbruvica was administered orally at 420 mg each day. The first finish level was non-inferiority of total response charge within the intent-to-treat inhabitants or relapsed/refractory inhabitants. The important thing secondary finish level was superiority of progression-free survival within the intent-to-treat inhabitants or relapsed/refractory inhabitants.
What’s the Significance the Part 3 BRUIN CLL-314 Trial?
This research is the primary to check Jaypirca and Imbruvica in treatment-naive sufferers and sufferers with Bruton tyrosine kinase inhibitor-naive relapsed/refractory CLL/SLL.
References
- “Pirtobrutinib vs ibrutinib in treatment-naïve and relapsed/refractory CLL/SLL: Outcomes from the primary randomized section III research evaluating a non-covalent and covalent BTK inhibitor,” by Dr. Jennifer Woyach, et al. Blood.
- “FDA grants conventional approval to pirtobrutinib for persistent lymphocytic leukemia and small lymphocytic lymphoma,” by U.S. Meals and Drug Administration. Information launch; Dec. 3, 2025.
- FDA Approves Jaypirca for Relapsed/Refractory CLL or SLL, by Alex Biese. CURE; Dec. 3, 2025. https://www.curetoday.com/view/fda-approves-jaypirca-for-r-r-cll-or-sll
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