Aaron Gerds, MD, MS

Meta: Dr. Aaron Gerds breaks down the outcomes of the phase 3 VERIFY trial, investigating rusfertide, for patients with polycythemia vera, a type of blood cancer.

Breaking Down the VERIFY Trial For Patients With Polycythemia Vera

Data from the phase 3 VERIFY trial were shared at the 2025 ASCO Annual Meeting, where investigators noted that rusfertide 

may be a potential treatment option for patients

 with polycythemia vera, a type of blood cancer, according to Dr. Aaron Gerds. This is because the investigational therapeutic agent was able to 

reduce or eliminate the need for phlebotomies

, a procedure which removes extra blood cells from the body by using a needle to take blood from the vein, improving quality of life and symptom control.

To further discuss this data, Gerds sat down for an interview with CURE, in which he 

highlighted what patients should know about the VERIFY trial

What should patients know about the VERIFY trial, presented at this year’s ASCO Annual Meeting?

The ASCO Annual Meeting is always a challenging conference for those of us in hematology. Hematologic neoplasms often represent a smaller portion of the larger ASCO meeting, and sometimes you really have to sift through numerous abstracts to find something truly impressive. However, this year, we had the fortunate event of a hematologic malignancy being featured as a plenary abstract. This is the prestigious session where they select the top few abstracts to present to a huge, enormous crowd, genuinely highlighting the importance of this research.

The fact that it concerns polycythemia vera is particularly significant for a somewhat rare blood cancer that often doesn't receive much attention. It's a disease we've known a great deal about for a long time but have relatively few approved therapies. As of today, there are only two FDA-approved drugs for polycythemia vera: Jakafi (ruxolitinib), approved in the second-line setting, and Besremi (ropeginterferon alfa-2b-njft), approved for all settings. Given this limited therapeutic landscape, a new, effective drug like rusfertide, which presents a completely different mechanism, is absolutely warranted for the field.

The trial presented at this year's ASCO meeting was a classic, definitive phase 3 registration study. It included patients who received the drug and those who did not, allowing for a thorough comparison with all the statistical power needed for regulatory approval. This was the trial in question.

Transcript has been edited for clarity and conciseness.

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Videos

Dr. Aaron Gerds breaks down the outcomes of the phase 3 VERIFY trial, investigating rusfertide, for patients with polycythemia vera, a type of blood cancer.

Breaking Down the VERIFY Trial for Patients With Polycythemia Vera

Expanding on a New Way to Manage Polycythemia Vera Without Iron Deficiency

The VERIFY trial explores rusfertide’s role in managing polycythemia vera by controlling red blood cell production without causing iron deficiency symptoms, explained by Dr. Aarron Gerds from the Cleveland Clinic. Traditional treatment with phlebotomies reduces red cells by inducing iron deficiency, which leads to fatigue and other symptoms.

Rusfertide works by trapping iron, thereby tricking the bone marrow into reducing red cell production while avoiding typical iron deficiency side effects. Dr. Gerds highlights this as a novel approach in polycythemia vera treatment and contrasts it with related myelofibrosis therapy, where hepcidin levels are lowered to treat anemia.

Dr. Aaron Gerds is an assistant professor of medicine at Cleveland Clinic Taussig Cancer Institute specializing in myeloproliferative neoplasms, myelodysplastic syndromes and stem cell transplantation.

What do we currently know about how rusfertide affects patient symptoms? is there any evidence it improves overall quality of life compared with standard phlebotomy?

The way we typically treat polycythemia is with phlebotomies, which lead to iron deficiency — and that’s how they control red blood cell production. But iron deficiency itself can cause a lot of symptoms: fatigue, muscle and joint aches, and even pica, a craving to eat ice or dirt. Many of the symptoms patients experience are tied to iron deficiency, which is part of how phlebotomies work to treat polycythemia vera.

Rusfertide works differently. It’s a synthetic version of hepcidin, the body’s natural regulator of iron. Think of hepcidin like a cork in a bottle: your body stores iron in that bottle, and hepcidin keeps the cork in place so the iron can’t get out. When rusfertide is present, iron stays trapped in those stores, and the bone marrow is tricked into thinking the body is iron deficient, even though it’s not. That way, you can control red blood cell production without causing the typical symptoms of iron deficiency. It’s a clever approach.

We’ve known about hepcidin for a long time — it’s something we learned about in medical school — but this is really the first time we’re harnessing it in this way to treat polycythemia vera.

Here’s an even cooler part: we’re using this same pathway in the opposite direction for myelofibrosis, a closely related disease. In myelofibrosis, we often see anemia, so we’re trying to lower hepcidin levels to help boost red cell production. In polycythemia vera, we’re effectively raising hepcidin to lower red cells, and in myelofibrosis, we’re lowering hepcidin to increase them. In the same field, we’re manipulating the same pathway in two different ways to treat two different problems.

The VERIFY trial explores rusfertide to manage polycythemia vera without causing iron deficiency symptoms, Dr. Aaron Gerds explained.

Key Takeaways for Patients With Myelofibrosis

Patients with myelofibrosis should reflect on their personal priorities and quality of life goals, understand the range of available JAK inhibitor treatment options, and openly communicate with their doctor to arrive at a shared decision for managing their disease.

Dosing JAK Inhibitors in Patients With Myelofibrosis

For most JAK inhibitors dosing starts at the maximum safe dose, while ruxolitinib often requires lower initial doses and dose reductions over the first 12 weeks when cytopenias typically worsen before partially improving, warranting consideration of earlier switching to alternative JAK inhibitors instead of pushing through transfusions.

Aaron Gerds, MD, MS

Breaking Down the VERIFY Trial for Patients With Polycythemia Vera

Expanding on a New Way to Manage Polycythemia Vera Without Iron Deficiency

Key Takeaways for Patients With Myelofibrosis

Dosing JAK Inhibitors in Patients With Myelofibrosis

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