New AML Therapy: Pivekimab Sunirine

ImmunoGen, a pharmaceutical company,  recently announced the findings for a new AML therapy for newly diagnosed patients, currently in phase 1b/2. In this article, we compiled the information on this new therapy that is out so far. 

Pivekimab sunirine (IMGN632) is an innovative antibody-drug conjugate (ADC) designed to target CD123, a protein found in AML cells and other blood cancers. This medication delivers potent anti-leukemic effects with fewer side effects on normal marrow cells. The results of using pivekimab sunirine both as a monotherapy in relapsed or refractory AML, and in combination therapy with azacitidine and venetoclax for newly diagnosed AML patients, have been promising so far. 

Pivekimab sunirine as a single therapy for relapsed or refractory AML patients

The study is currently active but does not recruit patients. It aims to assess the safety and tolerability of this medication. 91 patients were enrolled, with an overall response rate (ORR) of 21% and a complete remission rate of 17%.

Common treatment-related adverse events included febrile neutropenia, infusion reactions, and anemia. These results led to further investigation in a phase 1b/2 study, where pivekimab was combined with azacitidine and venetoclax in newly diagnosed AML patients. 

Triple therapy for newly diagnosed AML patients: pivekimab sunirine, azacitidine, and venetoclax 

The combination, known as the “pivekimab triplet,” demonstrated encouraging response rates, including high rates of minimal residual disease (MRD) negativity associated with deeper remission.

In this study, patients received: 

• pivekimab 0.045 mg/kg on day 7
• azacitidine on days 1-7
• venetoclax for 14 to 28 days per 28-day cycle
• 54% of patients achieved a complete response (CR)
• 76% of patients had MRD negativity.
• Patients with TP53 mutations also had high response rates, achieving a complete response rate of 88% and an MRD negativity rate of 80%.

The side effects were the usual ones reported with azacitidine and venetoclax (low platelets, bruising, gum bleeding). Other side effects included constipation, swelling, and nausea, and only 4% of patients discontinued due to adverse events.

Looking forward to updates and FDA Review

In conclusion, ImmunoGen's development of pivekimab sunirine (IMGN632) marks a significant advance in AML therapy, particularly for newly diagnosed patients and those with high-risk genetic mutations, such as TP53. The combination of pivekimab sunirine with azacitidine and venetoclax shows potential for deeper remissions, as reflected in the phase 1b/2 trial. 

While side effects were manageable, the high response rates seen in even the more complex cases show that it can provide a positive impact in future AML treatment protocols. As we await the release of further data, pivekimab sunirine continues to hold promise as a targeted and effective treatment option for AML patients.

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Sources: 

• Pivekimab Sunirine
• Immunogen
• Pivekimab sunirine (IMGN632), a novel CD123-targeting antibody–drug conjugate, in relapsed or refractory acute myeloid leukaemia: a phase 1/2 study
• Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms