Lead investigators from clinical trials evaluating eprenetapopt in patients with TP53 mutant MDS or AML presented positive, updated data at the 2021 ASH Annual Meeting. All studies evaluated the tolerability
Lead investigators from clinical trials evaluating eprenetapopt in patients with TP53 mutant MDS or AML presented positive, updated data at the 2021 ASH Annual Meeting. All studies evaluated the tolerability and efficacy of Aprea Therapeutics, Inc. (NASDAQ:APRE) lead product candidate, eprenetapopt.
Data summaries of the presentations are as follows:
| Title: Phase II Trial of Eprenetapopt (APR-246) in Combination with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplantation (SCT) Presenter: Asmita Mishra, M.D., H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida Oral Abstract Session: 723. Allogeneic Transplantation: Long-term Follow-up and Disease Recurrence |
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| Data Summary: In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 year post-transplant was 60% and the median RFS was 12.5 months. The overall survival (OS) at 1 year post-transplant was 79%, with a median OS of 20.6 months. The post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial. | |
| Title: Long-Term Follow-up and Combined Phase 2 Results of Eprenetapopt (APR-246) and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML) Presenter: David Sallman, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida Oral Abstract Session: 637. Myelodysplastic Syndromes—Clinical and Epidemiological: Treatment of High Risk Myelodysplastic Syndrome |
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| Data Summary: By ITT analysis (n=100), ORR was 69% and CR was 43% by International Working Group criteria; Biallelic TP53 mutation or complex karyotype was significantly associated with higher CR rate (49% versus 8%; P=0.01); combination therapy was well tolerated in treated patients. | |
| Title: Phase I and Expansion Study of Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML) Presenter: Guillermo Garcia-Manero, M.D., The University of Texas MD Anderson Cancer Center, Houston, Texas Poster Abstract Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III |
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| Data Summary: In 39 efficacy evaluable patients ORR was 64%, CR was 39%, and CR + CRi and the CR + CRh rates were each 56%. The triplet combination of eprenetapopt, venetoclax and azacitidine, was tolerable as an outpatient regimen. | |
Presentations of these data can be accessed from “Presentations” in the News and Events section of the Company’s website at Link.
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