For patients
Photo of child with stethoscope on father’s chest Photo of child with stethoscope on father’s chest

Actor portrayals.

Actor portrayals.

TREGZI delivered the benefits of transplant, while reducing certain side effects

Explore the clinical trial results

In a clinical trial, the efficacy and safety of TREGZI were compared with those of traditional stem cell transplant in people with different kinds of blood cancer. 

Proven through experience

About the trial

Precision-T was a multicenter phase 3 randomized trial that included people with different types of blood cancer, such as:

  • Acute lymphoblastic leukemia (ALL)
  • Acute myeloid leukemia (AML)
  • Myelodysplastic syndromes (MDS)

Treatment groups

People were randomized into 2 groups, where they received either TREGZI + tacrolimus (a chemotherapy-free immunosuppressant) or traditional allogeneic stem cell transplant + tacrolimus and methotrexate (a chemotherapy).

  • 93 people were in the TREGZI group
  • 94 people were in the traditional allogeneic stem cell transplant group

Medications to help reduce GVHD

To help lower the chance of developing certain side effects, specifically GVHD, after the transplant:

  • People in the TREGZI group received a course of treatment given after the transplant that included tacrolimus, a chemotherapy-free medication
  • People in the traditional allogeneic stem cell transplant group received both tacrolimus and methotrexate, administered through an intravenous infusion

    • Tacrolimus infusions were given the same way to everyone in the study:

    • People were started on a standard daily dose, which was increased or decreased as needed to keep levels in a safe range
    • If there were no signs of GVHD, the dose was slowly lowered starting about 3 months after the transplant, usually by about 20% each month until it was discontinued

    You may need to take other oral medications after your transplant. Your doctor will prescribe what is needed.

Goal of the study

The main goal of the study was to assess survival free from moderate or severe chronic GVHD (cGVHD), also called cGFS.

TREGZI gave people a greater chance of survival without moderate-to-severe cGVHD

~2x greater

chance of survival free of
moderate-to-severe cGVHD (cGFS)

78% of people who received TREGZI + tacrolimus were alive and free of cGVHD at 1 year after transplant compared with 38.4% of people who received traditional allogeneic stem cell transplant + tacrolimus and methotrexate

cGVHD, chronic graft-versus-host disease.

~3.5x lower

risk of developing
moderate-to-severe cGVHD

Just 12.6% of people who received TREGZI + tacrolimus developed cGVHD compared with 44% of people who received traditional allogeneic stem cell transplant + tacrolimus and methotrexate at 1 year after transplant

At 1 year, about 94% of people who received TREGZI + tacrolimus were alive compared with about 83% of those who received traditional allogeneic stem cell transplant + tacrolimus and methotrexate. The difference between the 2 treatment groups was not statistically meaningful.

Survival results are descriptive only and cannot be interpreted as definitive evidence.

TREGZI lowered the risk of severe infection

~2.5x lower

risk of severe infection

8.4% of people who received TREGZI + tacrolimus developed severe infections at 1 year after transplant compared with 16.1% of people who received traditional allogeneic stem cell transplant + tacrolimus and methotrexate

Aspects of health-related quality of life were also evaluated

  • Quality-of-life evaluation included individual’s reporting of physical well-being, functional well-being, social/family well-being, emotional well-being, as well as concerns specific to receiving bone marrow transplant (BMT)

Quality-of-life results are descriptive only and cannot be interpreted as definitive evidence.

Possible side effects

Although TREGZI has been designed to help lower the risk of certain complications, they may still occur. Because everyone responds differently to treatment, it is not possible to know whether you will experience any adverse effects or how severe they may be.

Side effects seen in ≥20% of people who received TREGZI in the clinical trial were:

  • Inflammation of the digestive tract
  • Diarrhea
  • Rash
  • Viral infections
  • Infections from an unknown pathogen
  • Abdominal pain
  • Vomiting
  • Nausea
  • Bacterial infections
  • Bleeding
  • Acute GVHD
  • Swelling
  • Fungal infections

These are not all the possible side effects of TREGZI.

Percent of people who experienced changes in key laboratory measures (≥10%)

Side effect % of people affected who received TREGZI + tacrolimus % of people affected who received traditional stem cell transplant + tacrolimus and methotrexate
Decrease in immune cells (lymphocytes) 98% 94%
Decrease in platelet counts 93% 96%
Decrease in white blood cells (leukocytes) 89% 89%
Decrease in neutrophil count 77% 83%
Decreased levels of hemoglobin 71% 81%
Increase in the liver enzyme alanine aminotransferase 12% 7%

There were 88 patients who received TREGZI + tacrolimus and 94 patients who received traditional stem cell transplant + tacrolimus and methotrexate.

The occurrence of some side effects was lower in people in the TREGZI group

Side effect % of people affected
who received TREGZI + tacrolimus % of people affected
who received traditional stem cell transplant + tacrolimus and methotrexate
Infections
Viral infections 51% 47%
Infections from an unknown pathogen 45% 56%
Bacterial infection 40% 38%
Fungal infections 20% 18%
Digestive disorders
Diarrhea 69% 79%
Stomach pain 45% 54%
Vomiting 44% 35%
Nausea 41% 44%
Immune system disorders
Acute GVHD (aGVHD) 38% 46%
General disorders and administration site conditions
Inflammation of the digestive tract (mucositis) 85% 88%
Swelling (edema) 30% 38%
Respiratory and chest disorders
Pneumonia 5% 17%
Skin disorders
Rash 65% 55%
Vascular disorders
Bleeding (hemorrhage) 39% 33%

These side effects occurred in fewer people who received TREGZI + tacrolimus compared to those who received traditional stem cell transplant + tacrolimus and methotrexate.

There were 88 patients who received TREGZI + tacrolimus and 94 patients who received traditional stem cell transplant + tacrolimus and methotrexate.

Tell your care team how you’re feeling

Always tell your care team about any symptoms you have, especially if they are new, getting worse, or bothering you.

Your team can help find ways to manage side effects you may be experiencing.

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IMPORTANT SAFETY INFORMATION AND INDICATION

ISI tray

ISI tray

INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

IMPORTANT SAFETY INFORMATION

Before you receive TREGZI, tell your healthcare provider about all your medical conditions, including if you have:

  • Lung or breathing problems
  • Heart problems
  • Liver problems
  • Kidney problems
  • A recent or active infection

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TREGZI can cause serious side effects, including:

  • Graft Failure. Failure to rebuild the blood and/or immune system, which may be fatal, can occur after receiving TREGZI. Your healthcare provider will monitor you closely after TREGZI administration.

  • Graft-Versus-Host Disease (GVHD). Immune reactions from the donor’s cells may occur soon (days) or long (months) after receiving TREGZI. Tell your healthcare provider right away about any signs and symptoms including rash, joint pain, diarrhea, or yellowing of the eyes.
  • Infusion Reactions. Infusion reactions can occur after TREGZI infusion. Tell your healthcare provider right away about any signs and symptoms including fever, chills, flushing, fatigue, shortness of breath, and dizziness/lightheadedness.
  • Secondary Cancer and Cancer from Donor Cells. New cancers can develop after treatment with TREGZI. If you are diagnosed with a new cancer after treatment, contact Orca Bio at 1-877-290-6722.
  • Transfer of Serious Infections. Transfer of serious infectious diseases can occur because TREGZI is made from the human blood cells of a donor. Transfer may occur even though donors are screened and tested for infectious diseases.

The most common side effects of TREGZI include inflammation of the digestive tract, diarrhea, rash, viral infections, infections from an unknown pathogen, abdominal pain, vomiting, nausea, bacterial infections, bleeding, acute graft-versus-host disease (aGVHD), swelling and fungal infections.

These are not all the possible side effects of TREGZI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

Please see accompanying full Prescribing Information including Patient Information.