ASCO 2025 | Efficacy and safety of pivekimab sunirine in patients with BPDCN: CADENZA study update

I’m really delighted to be here at ASCO on behalf of my co-authors to talk about the pivekimab sunirine study which is the CADENZA study for patients with BPDCN. So briefly, pivekimab sunirine or pivek is a CD123 antibody drug conjugate. So this new agent is designed to help treat patients who express that target CD123 and it turns out BPDCN is 100% of the time. So that’s the background. We then sought out to do what turns out to be a very large prospective study in our field, 84 patients overall, of whom 33 patients are frontline, and out of those 20 are the key analysis group or primary analysis population. So briefly, what we found with this IV drug, every three weeks can be given outpatient, is it was very safe and well tolerated, no capillary leak syndrome events, which does happen in some CD123 expressing agents. And the overall results were very promising, very encouraging. What we found is an overall CR rate, so complete remission rate of 70%, 70% in the frontline primary analysis population of those 20 patients. The overall response rate was even higher. In the relapse refractory group, which is a heavily pretreated high-risk group of patients, we also found an encouraging response rate. In the frontline setting, the median overall survival was 16 plus months, which is very good for this historically poor prognosis tumor. As I mentioned, it’s a safe, well-tolerated drug. You do have to look out for peripheral edema, which we saw in three quarters of the patients, and infusion-related reactions. So overall, we conclude from the Cadenza study, PVEC for BPDCN, that we have a novel CD123 ADC targeted agent, well tolerated, and could potentially represent a practice-changing paradigm for our field.

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