Woyach Discusses Updated BRUIN Data of Pirtobrutinib in CLL/SLL

Jennifer A. Woyach, MD, hematologist-oncologist, professor, the Division of Hematology, the Ohio State University Comprehensive Cancer Center– James, discusses background and updated findings from the phase 1/2 BRUIN study (NCT03740529) of pirtobrutinib (Jaypirca) for the treatment of heavily pretreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after prior treatment with a covalent Bruton tyrosine kinase (BTK) inhibitor.

Findings presented at ASH 2023 showed that at a median follow-up of 27.5 months, patients with CLL who had previously been treated with a covalent BTK inhibitor had a median progression-free survival (PFS) of 19.4 months with pirtobrutinib (95% CI, 16.6-22.1). At a median follow-up of 27.6 months, the median PFS in the BCL-2 inhibitor–naive group with pirtobrutinib was 23.0 months (95% CI, 19.6-28.4), and at a median follow-up of 22.2 months, patients in the BCL-2 inhibitor–exposed group had a median PFS of 15.9 months (95% CI, 13.6-17.5).

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0:09 | At ASH 2023, we discussed the long-term follow-up of pirtobrutinib in patients with relapsed/refractory CLL, which is a follow-up of the BRUIN phase 1/2 trial. And here we had about 30 months of follow-up on the study, and focused specifically on the group of patients who had received the prior covalent BTK inhibitor, so either ibrutinib, acalabrutinib [Calquence], or zanubrutinib [Brukinsa]. This cohort was about 280 patients. And then we broke that cohort down further into the patients who had previously been treated with the BCL2 inhibitor and the patients who were previously naive to a BCL2 inhibitor.

0:44 | Overall response rate has been reported before, it's over 80%, and it did not vary based upon whether patients had received a prior BCL2 inhibitor or not. We also see with long-term follow-up [that the] median progression-free survival is 19.4 months for that entire cohort. This actually did look a little bit different in the patients who had previously been treated with a BCL2 inhibitor and those that had not. Those patients who had received a prior BCL2 inhibitor had a median progression-free survival of about 16 months [and] those that had not had a median PFS of about 23 months. Importantly, the patients who had received a prior BCL2 inhibitor, as you would expect, were just a higher-risk group of patients in general, so they obviously had had more prior therapies. A number of them and either had [chimeric antigen receptor] T cells or even allogeneic stem cell transplants too, kind of showing us that the later in lines of therapy, as you would expect, the PFS is going to be shorter.