In AMPECT, 47% of patients received FYARRO for ≥6 months and 21% for
>1 year

  • The median duration on study at study closure, including survival follow-up, was 22 months (range, 1-66 months)2
  • The safety profile of FYARRO was consistent with other mTOR inhibitors, with no new safety signals observed1
  • 35% of patients required a dose reduction due to an adverse reaction
  • Three patients (9%) discontinued treatment due to an adverse reaction (pneumonitis, anemia, and noninfective cystitis)

Most adverse reactions were mild or moderate in severity (Grade 1 or 2) and manageable1

  • The most common adverse reactions (≥30%) were stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, and dysgeusia
  • The most common laboratory Grade 3 to 4 abnormalities (≥6%) were decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased hemoglobin, and increased lipase

Serious adverse reactions (SARs) occurred in 14 (41%) patients who received FYARRO

  • SARs in >5% of patients included infection, abdominal pain, dehydration, and upper gastrointestinal hemorrhage
  • Fatal adverse reactions occurred in 1 (2.9%) patient who received FYARRO and experienced upper gastrointestinal hemorrhage*

*Unrelated to treatment.1

AMPECT=Advanced Malignant PEComa Trial; mTOR=mechanistic target of rapamycin.

AMPECT: Adverse reactions in ≥10% of patients with PEComa who received FYARRO

ADVERSE REACTION FYARRO (N=34)
ALL GRADES (%) GRADES 3 TO 4* (%)
Gastrointestinal

GASTROINTESTINAL

 Stomatitisa 79 18
Nausea 50 0
Diarrheab 47 2.9
Vomiting 32 2.9
Abdominal painc 29 6
Constipation 24 2.9
Dry mouth 15 0
Hemorrhoids 12 0
General Disorders

GENERAL DISORDERS

 Fatigue 68 2.9
Edemad 50 2.9
Pyrexia 24 0
Skin & Subcutaneous Tissue Disorders

SKIN &
SUBCUTANEOUS
TISSUE DISORDERS

 Rashe 68 0
Alopecia 24 0
Pruritus 18 0
Dry skin 12 0
Nail disorder 12 0
Infections

INFECTIONS

 Infectionsf 59 12
Metabolism & Nutrition

METABOLISM & NUTRITION

 Decreased appetite 44 0
Dehydration 15 6
Nervous System

NERVOUS SYSTEM

 Dysgeusia 32 0
Headache 29 0
Peripheral neuropathyg 15 0
Dizzinessh 12 0
Investigations

INVESTIGATIONS

 Weight decreased 47 0
Musculoskeletal & Connective Tissue Disorders

MUSCULOSKELETAL
& CONNECTIVE
TISSUE DISORDERS

 Musculoskeletal paini 47 2.9
Respiratory, Thoracic, & Mediastinal Disorders

RESPIRATORY,
THORACIC, &
MEDIASTINAL
DISORDERS

Coughj 35 0
Pneumonitis 18 0
Dyspneak 12 0
Vascular Disorders

VASCULAR
DISORDERS

 Hypertension 29 2.9
Hemorrhagel 24 2.9
Psychiatric Disorders

PSYCHIATRIC
DISORDERS

 Insomnia 21 2.9
Eye Disorders

EYE DISORDERS

 Vision blurred 12 0

Grading according to NCI Common Terminology Criteria for Adverse Events Version 4.03.

a

Includes stomatitis, aphthous ulcer, mouth ulceration, esophageal ulcer.

b

Includes diarrhea and enteritis.

c

Includes abdominal pain, abdominal pain upper, and epigastric discomfort.

d

Includes face edema, generalized edema, edema, edema peripheral, and periorbital edema.

e

Includes dermatitis acneiform, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculopapular, rash papular, rash pruritic, and skin exfoliation.

f

Includes all reported infections, including but not limited to, upper respiratory tract infection, urinary tract infection, sinusitis, skin infection, folliculitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, pneumonia, vaginal infection.

g

Includes dysesthesia, hypoesthesia, neuropathy peripheral, paresthesia, and peripheral sensory neuropathy.

h

Includes dizziness, dizziness postural, and vertigo.

i

Includes arthralgia, back pain, musculoskeletal chest pain, myalgia, neck pain, noncardiac chest pain, pain in extremity.

j

Includes cough, productive cough, and upper-airway cough syndrome.

k

Includes dyspnea and dyspnea exertional.

l

Includes epistaxis, hemorrhoidal hemorrhage, mouth hemorrhage, post procedural hemorrhage, and upper GI hemorrhage. Includes 1 fatal adverse reaction of upper GI hemorrhage (unrelated to treatment).1

*No Grade 4 reactions were reported.

AMPECT=Advanced Malignant PEComa Trial; GI=gastrointestinal; NCI=National Cancer Institute; PEComa=perivascular epithelioid cell tumor.

Laboratory abnormalities occurring in
≥10% of patients

LABORATORY ABNORMALITY* FYARRO† (N=34)
ALL GRADES (%) GRADES 3 TO 4 (%)
Hematology

HEMATOLOGY

 Decreased lymphocytes 82 21
Decreased hemoglobin 68 6
Decreased leukocytes 41 0
Decreased neutrophils 35 0
Decreased platelets 35 0
Chemistry

CHEMISTRY

 Increased creatinine 82 0
Increased triglycerides 52 0
Increased cholesterol 48 3
Increased alanine aminotransferase
(ALT)		 47

 2.9
Decreased potassium 44 12
Decreased magnesium 42 0
Decreased albumin 35 2.9
Increased aspartate transaminase (AST) 32 2.9
Increased alkaline phosphatase 29 0
Decreased sodium 24 2.9
Decreased calcium 15 0
Decreased glucose 15 0
Decreased phosphate 15 9
Increased lipase 12 6
Increased glucose 12 12
Increased sodium 12 0

*

Grading according to NCI Common Terminology Criteria for Adverse Events Version 4.03.

†

The denominator used to calculate the rate varied from 33 to 34 based on the number of patients with a baseline value and at least 1 posttreatment value.

References: 1. Wagner AJ, Ravi V, Riedel RF, et al. nab-Sirolimus for patients with malignant perivascular epithelioid cell tumors. J Clin Oncol. 2021;39(33):3660-3670. doi:10.1200/JCO.21.01728 2. Wagner AJ, Ravi V, Riedel RF, et al. Study-end analysis from AMPECT, an open-label, phase 2 registration trial of patients with advanced malignant PEComa treated with nab-sirolimus, showing durability of response and long-term safety. Poster presented at: Connective Tissue Oncology Society Meeting; Vancouver, BC, Canada; November 16-19, 2022.

Next: Dosing Schedule

Safety

Adverse Reactions

Laboratory
Abnormalities

Managing adverse reactions

Indication

FYARRO® is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Important Safety Information

Contraindications

History of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin.

Warnings and Precautions

FYARRO can cause serious adverse reactions. Withhold, resume at reduced dose, or permanently discontinue FYARRO based on severity (See Dosage and Administration of full Prescribing Information).

Stomatitis: Stomatitis, including mouth ulcers and oral mucositis, occurred in 79% of patients, including 18% Grade 3.

Myelosuppression: FYARRO can cause myelosuppression including anemia, thrombocytopenia and neutropenia. Anemia occurred in 68% of patients; 6% were Grade 3. Thrombocytopenia and neutropenia occurred in 35% of patients each. Obtain blood counts at baseline and every 2 months for the first year of treatment and every 3 months thereafter, or more frequently if clinically indicated.

Infections: FYARRO can cause infections. Infections such as urinary tract infections (UTI), upper respiratory tract infections and sinusitis occurred in 59% of patients. Grade 3 infections occurred in 12% of patients, including a single case each of a UTI, pneumonia, skin, and abdominal infections. Monitor for signs and symptoms of infection.

Hypokalemia: FYARRO can cause hypokalemia. Hypokalemia occurred in 44% of patients, including 12% Grade 3 events. Monitor serum potassium prior to starting FYARRO and supplement potassium as medically indicated.

Hyperglycemia: FYARRO can cause hyperglycemia. Hyperglycemia occurred in 12% of patients, all of which were Grade 3 events. Monitor fasting serum glucose prior to starting FYARRO. During treatment, monitor serum glucose every 3 months in non-diabetic patients, or as clinically indicated. Monitor more frequently in diabetic patients.

Interstitial Lung Disease (ILD)/Non-Infectious Pneumonitis: FYARRO can cause ILD/non-infectious pneumonitis, which occurred in 18% of patients, all Grades 1 or 2. Monitor for new or worsening respiratory symptoms or radiological changes.

Hemorrhage: FYARRO can cause serious and sometimes fatal hemorrhage. Hemorrhage occurred in 24% of patients, including Grade 3 and Grade 5 events in 2.9% of patients each. Monitor for signs and symptoms.

Hypersensitivity Reactions: FYARRO can cause hypersensitivity reactions, including anaphylaxis. Anaphylaxis, angioedema, exfoliative dermatitis and hypersensitivity vasculitis have been observed with use of oral sirolimus. Monitor for hypersensitivity during and following each FYARRO infusion. Monitor for at least 2 hours following completion of the first infusion and as clinically indicated for each subsequent infusion. Reduce the rate, interrupt infusion, or permanently discontinue based on severity.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential hazard to the fetus and to use effective contraception while using FYARRO and for 12 weeks after the last dose.

Male Infertility: Azoospermia or oligospermia may occur.

Immunizations: Avoid live vaccines.

Adverse Reactions

The most common (≥30%) adverse reactions were stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, and dysgeusia.

The most common (≥6%) Grade 3 to 4 laboratory abnormalities were decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased hemoglobin, and increased lipase.

Drug Interactions

Strong CYP3A4 and/or P-gp Inhibitors or Inducers: Avoid concomitant use.

Moderate or Weak CYP3A4 Inhibitors: Reduce FYARRO dose.

Use in Specific Populations

Hepatic Impairment: Reduce the dose of FYARRO in patients with mild or moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

Lactation: Advise not to breastfeed.

Females and Males of Reproductive Potential: May impair fertility in females and males.

Please see full Prescribing Information.

Indication

FYARRO® is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

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FYARRO® is a registered trademark of Aadi Bioscience, Inc.

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