EHA 2021 | Update on the Phase I/II BRUIN study

We’re excited to share our data from the Phase I/II BRUIN study, which uses a novel BTK inhibitor, LOXO-305, and this is a non-covalent highly potent BTK inhibitor. So, there’s a different mechanism of action than the irreversible and covalent inhibitors that are currently marketed.

The advantage of this agent was clearly seen through the BRUIN trial, where we saw efficacy in patients who had failed prior covalent BTK inhibitors and saw what I would really describe as an exceptional safety signal. Very few grade three to four events, very low, basically not even remarkable rates of atrial fibrillation. And it goes to show that this highly selective non-covalent inhibitor has the potential to be maybe a best-in-class BTK inhibitor, by overcoming some of the limitations of what is currently available.

The data that we presented in the poster was looking specifically at the patients with non-Hodgkin lymphoma, and what we saw was efficacy sort of across the board. We saw efficacy, you know, in mantle cell, which was the largest cohort of patients, which obviously makes sense, you know, given the BTK inhibitors are quite effective.

But we also saw efficacy in Richter’s transformation. There’s a dedicated abstract for that that’s been presented at other meetings. We also saw efficacy in follicular lymphoma and some efficacy in diffuse large B-cell lymphoma. Specifically in the mantle cell cohort, about, approximately 50% of people responded, and the majority of them had prior BTK exposure, which is key for this drug, in that it does work in patients who are exposed to prior BTK inhibitors.