AI Article Synopsis
- Polycythemia vera (PV) is a type of blood cancer where the bone marrow produces too many blood cells, mostly due to a mutation in the JAK2 gene.
- Givinostat, a drug that inhibits cell growth related to JAK2, has shown positive results in earlier studies, prompting a long-term study on its effects in patients with PV.
- Over a 4-year follow-up of patients, givinostat was found to have a good safety profile, with only 10% experiencing serious side effects, while more than 80% showed positive treatment responses.
Article Abstract
Polycythemia vera (PV) is a BCR-ABL1-negative myeloproliferative neoplasm (MPN) characterized by excessive proliferation of erythroid, myeloid, and megakaryocytic components in the bone marrow, mainly due to a Janus kinase 2 gene mutation (JAK2). Givinostat, a histone-deacetylase inhibitor that selectively targets JAK2 cell growth, has demonstrated good efficacy and safety in three phase 1/2 studies in patients with PV. This manuscript focuses on the 4-year mean (2.8 year median) follow-up of an open-label, long-term study that enrolled 51 patients with PV (out of a total of 54 with MPN) who received clinical benefit from givinostat in these previous studies or on compassionate use, and who continued to receive givinostat at the last effective and tolerated dose. The primary objectives are to determine givinostat's long-term safety and tolerability, and efficacy evaluated by the investigators according to internationally recognized response criteria. During follow-up, only 10% of PV patients reported Grade 3 treatment-related adverse events (AEs), while none had Grade 4 or 5 treatment-related AEs. The overall response rate for the duration of follow-up was always greater than 80% in patients with PV. In conclusion, givinostat demonstrated a good safety and efficacy profile in patients with PV, data supporting long-term use in this population.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7936975 | PMC |
| http://dx.doi.org/10.1038/s41408-021-00445-z | DOI Listing |
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