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ASH 2020 | SY-1425 plus azacitidine treatment in AML

Thomas Cluzeau, MD, PhD, Central University Hospital of Nice, Nice, France, discusses a trial (NCT02807558) of azacitidine (aza) combined with SY-1425, a selective RARA agonist, in unfit acute myeloid leukemia (AML) patients and relapsed/refractory AML. SY-1425 sensitivity can be predicted using a biomarker test for RARA-positivity. Given preclinical evidence of the synergistic activity of SY-1425 plus aza, the trial aimed to characterize overall response rate for these patients. When RARA negative patients were compared to RARA+, the overall and complete response rates were lower, with a longer time to initial response. Adverse effects reported were consistent with those known for each single agent. Within the relapsed/refractory cohort, treatment was well tolerated, and response rates were promising despite the high prevalence of prior HMA treatment. These results support the use of a RARA biomarker test to predict sensitivity to SY-1425 and show significant benefit for RARA+ AML patients. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.

Transcript (edited for clarity)

During the ASH meeting, there were two presentation about the combination between azacitidine and syros-1425. It’s a new drug with a new target. 30% of acute myeloid leukemia and myelodysplastic syndrome have overexpression of RARA and the syros is a targeted therapy in this specific subgroup.

So, the first presentation was presented by De Botton, et al, in first line acute myeloid leukemia, not eligible for intensive chemo...

During the ASH meeting, there were two presentation about the combination between azacitidine and syros-1425. It’s a new drug with a new target. 30% of acute myeloid leukemia and myelodysplastic syndrome have overexpression of RARA and the syros is a targeted therapy in this specific subgroup.

So, the first presentation was presented by De Botton, et al, in first line acute myeloid leukemia, not eligible for intensive chemo. And, the overall response rate was really high with 67% of overall response rate, including 61% of complete remission, with a median overall survival at 8.4 months. A second presentation in relapse refractory acute myeloid leukemia was presented by Stein, et al, and the overall response rate was 19%, including a 10% of complete remission with a median overall survival at 5.9 months. This subgroup of patient is independent of molecular subtype. So, this new drug could be interesting in all subtype of acute myeloid leukemia, in patients, of course, with RARA positive.

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Disclosures

Thomas Cluzeau, MD, PhD, has undertaken clinical research with Aprea (PI GFM APR), Novartis, Alexion, Celgene/BMS, Amgen, Syros, Kartos and Arog; has participated in advisory boards with Celgene, Abbvie, Jazz Pharma, Roche, Novartis and Agios; has fulfilled an educational role with Novartis, Amgen, Sanofi and Astellas; and has attended international congresses with Sanofi, Pfizer, Celgene and Novartis.

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