Proven Efficacy and Safety

Three acute lymphoblastic leukemia patients pose together and smile

Children's Oncology Group (COG) Study AALL07P4

Sustained plasma asparagine depletion with a single dose of ONCASPAR

Median Plasma Asparaginase Activity and Mean Asparagine Levels After a single ONCASPAR dose During Induction in COG Study AALL07P41

A line chart showing the median plasma asparaginase activity and mean asparagine levels after ONCASPAR administration

Asparaginase activity Asparaginase concentration

aThe current approved recommended dosing of ONCASPAR is 2500 IU/m2 for patients aged ≤21 years and 2000 IU/m2 for patients aged >21 years. The AALL07P4 study used the same dose of 2500 IU/m2 for all patients, regardless of age.1,5

  • Patients in the COG AALL07P4 study ranged in age from 1 to 30 years (median 11 years)1
  • Eighteen days after administration, patients treated with ONCASPAR maintained mean plasma asparaginase activity above the therapeutic threshold of 0.1 IU/mL2
  • Nadir serum asparaginase activity ≥0.1 IU/mL is widely accepted as the therapeutic level necessary to achieve efficacy3,4

Sustained cerebrospinal fluid (CSF) asparagine depletion

Mean CSF Asparagine Concentration Over Time After ONCASPAR Administration in COG Study AALL07P41

A line graph showing the mean cerebrospinal fluid concentration over time.
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ONCASPAR 2500 IU/m2 dose given on day 4 of induction and day 15 of consolidationa

bThe current approved recommended dosing of ONCASPAR is 2500 IU/m2 for patients aged ≤21 years and 2000 IU/m2 for patients aged >21 years. The AALL07P4 study used the same dose of 2500 IU/m2 for all patients, regardless of age.1,5

  • Patients experienced a 67% reduction in CSF asparagine concentrations 4 days after a single induction dose5
  • CSF asparagine levels remained depleted 25 days after the administration of a single dose of ONCASPAR in the induction phase

Pegaspargase (ONCASPAR) is included in some central nervous system (CNS) prophylaxis regimens, which aim to prevent CNS disease or relapse by clearing leukemic cells within sites that cannot be readily accessed with systemic chemotherapy because of the blood-brain barrier.6,7

Dana-Farber Cancer Institute (DFCI) Study 11-001

95.8% 5-year overall survival (OS) rate8

5-year OS rate

for patients on an ONCASPAR-containing regimen in DFCI study 11-001

COG Study AALL0232

Patients on an ONCASPAR-containing regimen achieved minimal residual disease (MRD) negativity in COG study AALL023210

MRD Negative

72% of patients achieved MRD-negative status (MRD <0.01%) by the end of induction

Patients with end-induction MRD <0.01% had an 87% ± 1% 5-year event-free survival rate and a 93% ± 3% 8-year OS rate

Conversion

In a subset of patients tested for MRD at the end of consolidation, 69% (129/186) of the patients who were MRD positive at the end of induction on day 29 converted to MRD negativity by the end of consolidation

The ALL0232 study protocol included patients aged 1 to 30 years.10 The recommended dose of ONCASPAR for patients aged >21 years is 2000 IU/m2.5 Always refer to the approved Prescribing Information.

MRD after induction therapy has proven to be the strongest prognostic factor for outcomes in children, based on a multivariate analysis.11

Safety

ONCASPAR: A well-established safety profile

The most common (>5%) grade ≥3 adverse reactions with ONCASPAR were hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections.5

Grade 3/4 TEAEs Reported for ≥5% of Subjects Treated With ONCASPAR in COG Study AALL07P41

Treatment-Emergent
Adverse Event (TEAE)
ONCASPAR
2500 IU/m2 (N=52)
n (%)
Neutrophil count decreased
27 (51.9)
Febrile neutropenia
22 (42.3)
Alanine aminotransferase increased
19 (36.5)
White blood cell count decreased
15 (28.8)
Anemia
14 (26.9)
Platelet count decreased
13 (25.0)
Aspartate aminotransferase increased
11 (21.2)
Anaphylactic reaction
10 (19.2)
Hyperglycemia
9 (17.3)
Hypocalcemia
7 (13.5)
Hyponatremia
7 (13.5)
Abdominal pain
6 (11.5)
Blood bilirubin increased
6 (11.5)
Hypokalemia
6 (11.5)
Peripheral motor neuropathy
6 (11.5)
Stomatitis
6 (11.5)
Dehydration
5 (9.6)
Hypertriglyceridemia
5 (9.6)
Hypoxia
5 (9.6)
Lipase increased
5 (9.6)
Vomiting
5 (9.6)
Decreased appetite
4 (7.7)
Gamma-glutamyltransferase increased
4 (7.7)
Headache
4 (7.7)
Amylase increased
3 (5.8)
Blood cholesterol increased
3 (5.8)
Pancreatitis
3 (5.8)
Syncope
3 (5.8)

The current approved recommended dosing of ONCASPAR is 2500 IU/m2 for patients aged ≤21 years and 2000 IU/m2 for patients aged >21 years. The AALL07P4 study used the same dose of 2500 IU/m2 for all patients, regardless of age.1,5 Always refer to the approved prescribing information.

Learn more about the role of ONCASPAR in AYA treatment

AYA Treatment Guidelines
An acute lymphoblastic leukemia patient and their partner meet with a doctor.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION Section

CONTRAINDICATIONS

  • History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR (pegaspargase) or to any of the excipients.
  • History of serious thrombosis with prior L-asparaginase therapy.
  • History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy.
  • History of serious hemorrhagic events with prior L-asparaginase therapy.
  • Severe hepatic impairment.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR (pegaspargase) or to any of the excipients.
  • History of serious thrombosis with prior L-asparaginase therapy.
  • History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy.
  • History of serious hemorrhagic events with prior L-asparaginase therapy.
  • Severe hepatic impairment.

WARNINGS and PRECAUTIONS 

Anaphylaxis and Serious Hypersensitivity Reactions: Anaphylaxis and serious hypersensitivity reactions can occur. The risk of serious hypersensitivity reactions is higher in patients with known hypersensitivity to (E.) coli derived L-asparaginase formulations. Premedicate patients 30-60 minutes prior to administration of ONCASPAR. Observe patients for 1 hour after administration in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Discontinue ONCASPAR in patients with serious hypersensitivity reactions.

Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, can occur. Discontinue ONCASPAR in patients with serious thrombotic events.

Pancreatitis: Pancreatitis can occur. Fatal outcomes have been reported. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Discontinue ONCASPAR in patients where pancreatitis is suspected. If pancreatitis is confirmed, do not resume ONCASPAR. 

Glucose Intolerance: Glucose intolerance can occur and, in some cases, be irreversible. Monitor serum glucose. 

Hemorrhage: Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia can occur. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy. Discontinue ONCASPAR for severe or life-threatening hemorrhage. 

Hepatotoxicity: Hepatotoxicity and abnormal liver function can occur. Evaluate bilirubin and transaminases at least weekly during cycles of treatment through at least 6 weeks after the last dose. In the event of serious liver toxicity, discontinue ONCASPAR and provide supportive care.

ADVERSE REACTIONS

The most common grade 3 and 4 adverse reactions with ONCASPAR (>5%) included hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections. 

INDICATIONS AND USAGE

ONCASPAR® (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with:

  • First-line acute lymphoblastic leukemia (ALL)
  • ALL and hypersensitivity to native forms of L-asparaginase
Please see Full Prescribing Information.