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SOHO 2025 | Pirtobrutinib in R/R CLL: ongoing trials and evaluating this agent in earlier lines

In this video, Nirav Niranjan Shah, MD, Medical College of Wisconsin, Milwaukee, WI, discusses the potential of pirtobrutinib in treating B-cell malignancies, particularly relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Dr Shah highlights that pirtobrutinib has shown a high overall response rate in patients with prior BTK exposure, with ongoing trials investigating its use in earlier settings. This interview took place at the 13th Annual Meeting of the Society of Hematologic Oncology (SOHO 2025) in Houston, TX.

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Transcript

Yeah, so pirtobrutinib is another sort of next generation BTK targeting drug. This is a non-covalent inhibitor. And, you know, similar to what I just talked about, degrader, this drug can help overcome mutations that occur in patients that get standard covalent BTK inhibitors. So the drug was initially approved based on the BRUIN clinical trial, very large clinical trial across multiple B-cell malignancies, but showed a really high overall response rate in patients who had relapsed/refractory CLL, including those who had prior BTK exposure...

Yeah, so pirtobrutinib is another sort of next generation BTK targeting drug. This is a non-covalent inhibitor. And, you know, similar to what I just talked about, degrader, this drug can help overcome mutations that occur in patients that get standard covalent BTK inhibitors. So the drug was initially approved based on the BRUIN clinical trial, very large clinical trial across multiple B-cell malignancies, but showed a really high overall response rate in patients who had relapsed/refractory CLL, including those who had prior BTK exposure. This drug is further along, and so being FDA-approved, they’ve now moved to pivotal clinical trials. They had the 321 study recently that was presented at a prior ASH and now published that looked at pirtobrutinib in sort of the relapsed/refractory setting against standard chemoimmunotherapy and again showed a PFS benefit. They’ve now moved that to a frontline study in the 313. You know, the data hopefully will be out at this ASH, I would imagine, and we’re excited, but there’s a press release that suggests a positive trial. And so that’ll be really interesting to see what does pirtobrutinib look like as a single agent in the frontline untreated CLL population? Again, the idea with moving these next generation drugs forward is that potentially they’re safer, better tolerated, and maybe they can prevent mutations from happening, leading to longer duration of responses. So the jury’s still out on some of that other stuff, but excited to see the drug move forward. Having worked on that molecule as well as part of clinical trials, I was very excited by the promise that it has for our patients.

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