What type of study is this?

This is a Pre-Registered Trial study.

What question did this study set out to answer?

To evaluate the safety and efficacy of pegargiminase in combination with azacitidine and venetoclax for high-risk AML patients.

December 8, 2025BloodOpen Access

Results of the Phase 1B study of pegargiminase (ADI-PEG 20) in combination with AZA-VEN in newly diagnosed high-risk AML patients not candidates for intensive chemotherapy

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Authors

MSMikkael A. SekeresUniversity of Miami AJAmanda JohnstonUniversity of Pittsburgh NDNicole DeFord

Discussion

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Implication

Phase 1B results show high response rates in newly diagnosed AML patients treated with pegargiminase, azacitidine, and venetoclax, indicating its potential effectiveness.

Key Points

To evaluate the safety and efficacy of pegargiminase in combination with azacitidine and venetoclax for high-risk AML patients.
Phase 1B trial with newly diagnosed AML patients not candidates for intensive chemotherapy.
Patients received pegargiminase at 36 mg/m2 with azacitidine and venetoclax in 28-day cycles.
Primary outcomes included safety, objective response, and overall survival.
16 out of 23 evaluable patients achieved a complete response (69.6%).
Objective response rate of 91.3% was noted among evaluable patients.
Median overall survival was 19.1 months.

Cite This Study

Sekeres et al. (2025) studied this question.

synapsesocial.com/papers/69362f7d4fa91c937236e467 https://doi.org/10.1182/blood-2025-1650

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Implication

Phase 1B results show high response rates in newly diagnosed AML patients treated with pegargiminase, azacitidine, and venetoclax, indicating its potential effectiveness.

Results of the Phase 1B study of pegargiminase (ADI-PEG 20) in combination with AZA-VEN in newly diagnosed high-risk AML patients not candidates for intensive chemotherapy

Discussion

Member takes

Implication

Key Points

Cite This Study

Results of the Phase 1B study of pegargiminase (ADI-PEG 20) in combination with AZA-VEN in newly diagnosed high-risk AML patients not candidates for intensive chemotherapy

Discussion

Member takes

Implication

Key Points

Cite This Study

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