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Risk-Adjusted Safety Analysis of Pacritinib in Myelofibrosis Patients

May, 05, 2023 | Other Cancers

KEY TAKEAWAYS

  • The safety profile of the novel oral JAK2/IRAK1 inhibitor pacritinib in patients with cytopenic myelofibrosis was studied in Phase 2 PAC203 and Phase 3 PERSIST-2 trials.
  • The aim was to describe the safety profile of pacritinib in patients with myelofibrosis and present a risk-adjusted safety analysis accounting for different treatment times.
  • The study conducted a risk-adjusted safety analysis of event rates and compared them to the best available therapy (BAT) arm in the trials.
  • Pacritinib did not cause excessive bleeding, cardiac events, secondary malignancies, or thrombosis, even in patients with severe thrombocytopenia.
  • The rate of total events was higher on pacritinib compared to BAT, and the rate of fatal events was lower.

Astudy analyzed the safety profile of pacritinib, a novel oral JAK2/IRAK1 inhibitor, in patients with cytopenic myelofibrosis, based on Phase 2 PAC203 and Phase 3 PERSIST-2 trials.

The researchers conducted a risk-adjusted safety analysis to consider the extended treatment durations on the pacritinib arms compared to the best available therapy (BAT). Although pacritinib showed a higher rate of overall events than BAT, it had a lower rate of fatal events. There was no excess bleeding, cardiac events, secondary malignancy, or thrombosis, including in patients with severe thrombocytopenia.

Source: https://pubmed.ncbi.nlm.nih.gov/36467816/

Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02055781

Pemmaraju N, Harrison C, Gupta V, Verstovsek S, Scott B, Oh ST, Palandri F, Al-Ali HK, Sobas M, McMullin MF, Mesa R, Buckley S, Roman-Torres K, Vannucchi A, Yacoub A. Risk-adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis. EJHaem. 2022 Oct 20;3(4):1346-1351. doi: 10.1002/jha2.591. PMID: 36467816; PMCID: PMC9713029.

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