The pharmaceutical company Lilly has reported on the results of the phase 3 BRUIN CLL-321 study, in which the effectiveness of a new drug called pirtobrutinib has been evaluated in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SCLL). . This innovative treatment is a reversible inhibitor of Bruton’s tyrosine kinase (BTK), which means that it works by blocking a key protein in the development of this type of cancer.
The results of the study have shown that pirtobrutinib is more effective than other commonly used treatments, such as idelalisib combined with rituximab or bendamustine also with rituximab. This effectiveness has been confirmed with progression-free survival (PFS), that is, the time that patients live without the disease progressing. Specifically, patients treated with pirtobrutinib had a 46% reduction in the risk of relapse or death compared to the other treatments.
These findings have been presented at the 66th Annual Meeting of the American Society of Hematology (ASH), highlighting the importance of this advance in the treatment of complex hematological diseases. Dr. Jeff Sharman, principal investigator of the trial, noted the relevance of the findings in a press release published by Lilly: “These results demonstrate the ability of pirtobrutinib to provide clinically meaningful results after the use of covalent BTK inhibitors, which is especially notable given the poor prognosis of the patient population included in the BRUIN CLL-321 trial”
He adds: “These data also show that pirtobrutinib can significantly prolong the time to next treatment with a median of approximately two years. “In combination with the safety results, the BRUIN CLL-321 data are relevant when considering treatment sequencing in this context.”
A big step forward in the fight against leukemia
This trial included 238 patients who had previously received other therapies, including BTK inhibitors, and many of whom had high-risk characteristics that make recovery difficult, such as specific genetic mutations. The results were encouraging, with a median progression-free survival of 14 months for those receiving pirtobrutinib, versus 8.7 months in the control group.
Pirtobrutinib has proven to be a valuable option for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who no longer respond to other previous treatments.
The treatment also showed a favorable safety profile, with fewer serious side effects and fewer treatment interruptions compared to the other options tested. This trial is unique because it focused exclusively on patients who had already been treated with BTK inhibitors, a group with limited therapeutic options. According to Dr. David Hyman, Lilly’s chief medical officer, “these results reinforce the potential of pirtobrutinib to significantly improve the quality of life for people with B-cell diseases, such as chronic lymphocytic leukemia.”
Pirtobrutinib is marketed as Jaypirca® and already has accelerated approval by the United States Food and Drug Administration (FDA) for the treatment of adult patients with CLL/CPLL who have received at least two prior lines of treatment and adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic treatment. This advance is part of the BRUIN program, which includes several ongoing studies aimed at improving therapies for patients with hematological cancers.
