Reduced POMP Dosing Shows Comparable Efficacy in ALL Maintenance

In an interview with Pharmacy Times, Arefa Bacchus, PharmD, PGY2 oncology pharmacy resident at Atrium Health Wake Forest Baptist in Winston-Salem, North Carolina, discussed findings from a study at her institution presented at the HOPA Annual Meeting 2025. She focused on their findings when evaluating the efficacy and tolerability of empirically reduced starting doses of POMP therapy (mercaptopurine [Purinethol; Teva Pharmaceuticals], methotrexate [Trexall; Teva Pharmaceuticals], vincristine [Marqibo; Acrotech Biopharma], and a steroid) for patients with acute lymphoblastic leukemia (ALL).

Pharmacy Times: Can you discuss what you presented at HOPA 2025?

Arefa Bacchus, PharmD: My project was on lower starting doses of POMP therapy. So that’s 6-mercaptopurine, methotrexate, vincristine, and a steroid—either prednisone or dexamethasone. POMP therapy is utilized in patients who have ALL. It’s part of the phase called maintenance therapy.

A lot of our protocols have standardized dosing to give to patients, but our institution actually shifted to an empirically reduced starting dose to help with tolerability for patients. The study was evaluating whether we are providing our patients with the most appropriate dosing and ensuring that we’re not compromising efficacy. Our study didn’t find a difference in terms of efficacy and actually saw that some patients tolerated the empirically reduced dosing better than the protocol-established dosing.

Pharmacy Times: What challenges did the study address?

Bacchus: The challenges were mostly around the tolerability of the doses. Our providers noticed that patients really struggled with titrating the protocol-established dosing. So our study looked at the challenges of starting patients on higher doses, the resulting toxicities, and how to manage them.

With the empirical dosing, we were able to start patients on lower doses and still titrate them up in a way that avoided those toxicities. Being able to address that helped improve the quality of life for our patients.

Pharmacy Times: With both groups showing similar relapse-free survival at 180 days post-maintenance, what does this suggest about the safety of empirically reducing starting doses?

Bacchus: Unfortunately, the patient population—or the patient sample size—at our institution was pretty small, so drawing definitive conclusions is difficult. But from the data we were able to collect, seeing similarities in efficacy with relapse-free survival shows us that we’re not causing harm to our patients. That’s really what we didn’t want to see. So, being able to have that similar relapse-free survival was a good outcome.

Pharmacy Times: How has the shift to empirically reduced doses impacted pharmacy workflow?

Bacchus: I would say, in terms of workflow, it's similar when it comes to checking in on patients for toxicities. But there’s more discussion around what dosing to start patients on. Even though we’ve shifted to empirically starting doses, the percentage of that reduction is still variable. So, having those discussions with the multidisciplinary team is definitely important. Pharmacists definitely have a say in what they think, based on how the patient is presenting, providers give their opinions, and then they create a plan together.

Pharmacy Times: How has this change influenced collaboration between pharmacists, oncologists, and nurses in the outpatient setting?

Bacchus: Yeah, I think similarly—working together to make sure we’re communicating with patients well, ensuring they have transparency and feel comfortable reaching out to us if they’re experiencing toxicities—is really important. But also, just being able to provide education to patients up front is very vital. Being able to do that in the outpatient setting is definitely a great opportunity to have.

Pharmacy Times: For health care providers looking to optimize maintenance dosing while minimizing toxicity, how might these findings influence real-world practice?

Bacchus: So from my knowledge, there are multiple institutions doing something similar—starting with a reduced dose. I think we definitely need larger studies to really show the efficacy and tolerability of this approach. Unfortunately, there just isn’t a lot of data out there.

When we pitched the idea for this project—or when my mentors did, and I conducted the project—we realized there wasn’t much out there to compare it to. So, this is really a first-of-its-kind type of study. Hopefully, in the future, we can do a larger evaluation, either across multiple institutions or at a larger institution.

One thing we’ve thought about is our methodology for this study. We unfortunately had to exclude a lot of patients due to our inclusion criteria—they had to be started on all four of the POMP regimen agents up front and be on therapy for a full year to be evaluated. If we were to go back, maybe we would include patients who were on three of the drugs from the regimen and see what those outcomes would look like.

The hope is that in the future, we’ll be able to include a larger patient population to better understand the outcomes and draw more meaningful conclusions.