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3. Erratum to: Retrospective analysis of pacritinib in patients with myelofibrosis and severe thrombocytopenia

Author

Verstovsek, Srdan, primary, Mesa, Ruben, additional, Talpaz, Moshe, additional, Kiladjian, Jean-Jacques, additional, Harrison, Claire N., additional, Oh, Stephen T., additional, Vannucchi, Alessandro M., additional, Rampal, Raajit, additional, Scott, Bart L., additional, Buckley, Sarah A., additional, Craig, Adam R., additional, Roman-Torres, Karisse, additional, and Mascarenhas, John O., additional

Published
2024
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5. Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis

Author

Gerds, Aaron T., Savona, Michael R., Scott, Bart L., Talpaz, Moshe, Egyed, Miklos, Harrison, Claire N., Yacoub, Abdulraheem, Vannucchi, Alessandro, Mead, Adam J., Kiladjian, Jean-Jacques, O'Sullivan, Jennifer, García-Gutiérrez, Valentin, Bose, Prithviraj, Rampal, Raajit K., Miller, Carole B., Palmer, Jeanne, Oh, Stephen T., Buckley, Sarah A., Mould, Diane R., Ito, Kaori, Tyavanagimatt, Shanthakumar, Smith, Jennifer A., Roman-Torres, Karisse, Devineni, Sri, Craig, Adam R., and Mascarenhas, John O.

Published
2020
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10. POSTER: MDS-460 Efficacy of Pacritinib for Spleen, Symptoms, and Anemia Benefit in Myelofibrosis Patients Across the Cytopenic Spectrum

Author

Bose, Prithviraj, primary, Gagelmann, Nico, additional, Gupta, Vikas, additional, McLornan, Donal, additional, Vachhani, Pankit, additional, Al-Ali, Hafia Kathrin, additional, Ali, Haris, additional, Treskes, Philipp, additional, Buckley, Sarah, additional, Roman-Torres, Karisse, additional, and Scott, Bart, additional

Published
2023
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11. MDS-460 Efficacy of Pacritinib for Spleen, Symptoms, and Anemia Benefit in Myelofibrosis Patients Across the Cytopenic Spectrum

Author

Bose, Prithviraj, primary, Gagelmann, Nico, additional, Gupta, Vikas, additional, McLornan, Donal, additional, Vachhani, Pankit, additional, Al-Ali, Hafia Kathrin, additional, Ali, Haris, additional, Treskes, Philipp, additional, Buckley, Sarah, additional, Roman-Torres, Karisse, additional, and Scott, Bart, additional

Published
2023
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12. MPN-111 SVR (Spleen Volume Reduction) Predicts OS (Overall Survival) in MF (Myelofibrosis) Patients on PAC (Pacritinib) but Not BAT (Best Available Therapy): PERSIST-2 Landmark OS Analysis

Author

Ajufo, Helen, primary, Bewersdorf, Jan Philipp, additional, Harrison, Claire, additional, Palandri, Francesca, additional, Mascarenhas, John, additional, Palmer, Jeanne, additional, Gerds, Aaron, additional, Kiladjian, Jean-Jacques, additional, Buckley, Sarah, additional, Derkach, Andriy, additional, Roman-Torres, Karisse, additional, and Rampal, Raajit, additional

Published
2023
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13. POSTER: MPN-111 SVR (Spleen Volume Reduction) Predicts OS (Overall Survival) in MF (Myelofibrosis) Patients on PAC (Pacritinib) but Not BAT (Best Available Therapy): PERSIST-2 Landmark OS Analysis

Author

Ajufo, Helen, primary, Bewersdorf, Jan Philipp, additional, Harrison, Claire, additional, Palandri, Francesca, additional, Mascarenhas, John, additional, Palmer, Jeanne, additional, Gerds, Aaron, additional, Kiladjian, Jean-Jacques, additional, Buckley, Sarah, additional, Derkach, Andriy, additional, Roman-Torres, Karisse, additional, and Rampal, Raajit, additional

Published
2023
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15. P1030: SPLEEN VOLUME REDUCTION PREDICTS SURVIVAL IN MYELOFIBROSIS PATIENTS ON PACRITINIB BUT NOT BEST AVAILABLE THERAPY: PERSIST-2 LANDMARK OVERALL SURVIVAL ANALYSIS

Author

Bewersdorf, Jan, primary, Ajufo, Helen, additional, Harrison, Claire, additional, Palandri, Francesca, additional, Mascarenhas, John, additional, Palmer, Jeanne, additional, Gerds, Aaron T., additional, Kiladjian, Jean-Jacques, additional, Derkach, Andrii, additional, Roman-Torres, Karisse, additional, Buckley, Sarah, additional, and Rampal, Raajit K, additional

Published
2023
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16. Efficacy and Safety of Pacritinib vs Placebo for Patients With Severe COVID-19

Author

Cafardi, John, primary, Miller, Carole, additional, Terebelo, Howard, additional, Tewell, Chad, additional, Benzaquen, Sadia, additional, Park, David, additional, Egan, Pamela, additional, Lebovic, Daniel, additional, Pettit, Kristen, additional, Whitman, Eric, additional, Tremblay, Douglas, additional, Feld, Jonathan, additional, Buckley, Sarah, additional, Roman-Torres, Karisse, additional, Smith, Jennifer, additional, Craig, Adam, additional, and Mascarenhas, John, additional

Published
2022
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18. Pacritinib Is a Potent ACVR1 Inhibitor with Significant Anemia Benefit in Patients with Myelofibrosis

Author

Oh, Stephen T, primary, Mesa, Ruben, additional, Harrison, Claire, additional, Bose, Prithviraj, additional, Gerds, Aaron T., additional, Heaney, Mark L., additional, Gupta, Vikas, additional, Scott, Bart L., additional, Kiladjian, Jean-Jacques, additional, Lucchesi, Alessandro, additional, Buckley, Sarah, additional, Tyavanagimatt, Shanthakumar, additional, Roman-Torres, Karisse, additional, Mascarenhas, John, additional, and Verstovsek, Srdan, additional

Published
2022
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19. Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis

Author

Pemmaraju, Naveen, primary, Harrison, Claire, additional, Gupta, Vikas, additional, Verstovsek, Srdan, additional, Scott, Bart, additional, Oh, Stephen T., additional, Palandri, Francesca, additional, Al‐Ali, Haifa Kathrin, additional, Sobas, Marta, additional, McMullin, Mary Frances, additional, Mesa, Ruben, additional, Buckley, Sarah, additional, Roman‐Torres, Karisse, additional, Vannucchi, Alessandro, additional, and Yacoub, Abdulraheem, additional

Published
2022
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21. Poster: MPN-141 Retrospective Comparison of Patient Outcomes on Pacritinib Versus Ruxolitinib in Patients With Myelofibrosis and Thrombocytopenia

Author

Harrison, Claire, primary, Bose, Prithviraj, additional, Mesa, Ruben, additional, Gerds, Aaron, additional, Oh, Stephen, additional, Kiladijan, Jean-Jacques, additional, Garcia-Gutierrez, Valentin, additional, Vannucchi, Alessandro, additional, Scheid, Christof, additional, Sobas, Marta, additional, Verstovsek, Srdan, additional, Buckley, Sarah, additional, Roman-Torres, Karisse, additional, and Mascarenhas, John, additional

Published
2022
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28. Risk-adjusted safety analysis of pacritinib (PAC) in patients (pts) with myelofibrosis (MF).

Author

Pemmaraju, Naveen, primary, Scott, Bart L., additional, Savona, Michael R., additional, Oh, Stephen T., additional, Harrison, Claire, additional, Vannucchi, Alessandro M., additional, Palandri, Francesca, additional, Al-Ali, Haifa Kathrin, additional, Sobas, Marta, additional, McMullin, Mary Frances, additional, Gupta, Vikas, additional, Mesa, Ruben A., additional, Buckley, Sarah, additional, Roman-Torres, Karisse, additional, Verstovsek, Srdan, additional, and Yacoub, Abdulraheem, additional

Published
2022
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30. The Impact of Pacritinib on Myelofibrosis Symptoms in Patients with Moderate and Severe Thrombocytopenia: A Retrospective Analysis of Patients in the Persist-2 Study

Author

Palmer, Jeanne M., primary, Mesa, Ruben A., additional, Oh, Stephen T., additional, Rampal, Raajit, additional, Buckley, Sarah A, additional, Roman-Torres, Karisse, additional, Verstovsek, Srdan, additional, Mascarenhas, John, additional, Vannucchi, Alessandro M., additional, Kiladjian, Jean-Jacques, additional, Harrison, Claire N., additional, Bose, Prithviraj, additional, Craig, Adam R, additional, and Gerds, Aaron T., additional

Published
2021
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32. A Retrospective Head-to-Head Comparison between Pacritinib and Ruxolitinib in Patients with Myelofibrosis and Moderate to Severe Thrombocytopenia

Author

Mascarenhas, John, primary, Bose, Prithviraj, additional, Kiladjian, Jean-Jacques, additional, Mesa, Ruben A., additional, Gerds, Aaron T., additional, Gupta, Vikas, additional, Harrison, Claire N., additional, Yacoub, Abdulraheem, additional, Garcia Gutierrez, Valentín, additional, Vannucchi, Alessandro M., additional, Scheid, Christof, additional, Velez Tenza, Patricia, additional, Buckley, Sarah A, additional, Roman-Torres, Karisse, additional, Oh, Stephen T., additional, Sobas, Marta, additional, Lavie, David, additional, and Verstovsek, Srdan, additional

Published
2021
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33. Retrospective analysis of pacritinib in patients with myelofibrosis and severe thrombocytopenia

Author

Verstovsek, Srdan, primary, Mesa, Ruben, additional, Talpaz, Moshe, additional, Kiladjian, Jean-Jacques, additional, Harrison, Claire N., additional, Oh, Stephen T., additional, Vannucchi, Alessandro M., additional, Rampal, Raajit, additional, Scott, Bart L., additional, Buckley, Sarah A., additional, Craig, Adam R., additional, Roman-Torres, Karisse, additional, and Mascarenhas, John O., additional

Published
2021
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38. Pacritinib demonstrates spleen volume reduction in patients with myelofibrosis independent of JAK2V617Fallele burden

Author

Tremblay, Douglas, Mesa, Ruben, Scott, Bart, Buckley, Sarah, Roman-Torres, Karisse, Verstovsek, Srdan, and Mascarenhas, John

Abstract

Myelofibrosis (MF) has heterogeneous clinical manifestations, with some patients exhibiting a myelodepletive phenotype characterized by cytopenias and an absent or low JAK2V617Fallele burden. Ruxolitinib may be less effective in these patients. We assessed the efficacy of pacritinib, a JAK2/IRAK1 inhibitor, in MF patients with low JAK2V617Fallele burden. In this post hoc analysis of the PERSIST-1 and -2 trials, patients with MF randomized to pacritinib or best available therapy (BAT) were stratified by JAK2V617Fallele burden quartile for spleen response of ≥35% and improvement in total symptom score of ≥50%. Five hundred thirty-six patients were included. Patients with lower JAK2V617Fallele burden had smaller baseline spleens and lower hemoglobin and platelet counts as compared with higher allele burden patients. Among pacritinib-treated patients, spleen responses were observed across all JAK2V617Fallele burden quartiles and in JAK2V617F−disease. No spleen responses were observed among BAT-treated patients with allele burden ≤50% or JAK2V617F−disease. The intention-to-treat response rate was significantly higher on the pacritinib arm for JAK2V617F−disease (23.0% vs 0%; P= .033), and for the lowest allele burden quartiles (0%-25%: 20.9% vs 0%, P< .001; 25%-50%: 15.4% vs 0%, P= .020). There were significantly more symptom responders with pacritinib vs BAT in the 0% to 25% and 25% to 50% cohorts. Pacritinib treatment led to superior spleen and symptom burden reduction compared with BAT in patients with absent or low JAK2V617Fallele burden, suggesting that pacritinib may be uniquely suited for patients with myelodepletive MF.

Published
2020
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41. Pacritinib Response Is Associated With Overall Survival in Myelofibrosis: PERSIST‐2 Landmark Analysis of Survival.

Author

Ajufo, Helen, Bewersdorf, Jan Philipp, Harrison, Claire, Palandri, Francesca, Mascarenhas, John, Palmer, Jeanne, Gerds, Aaron, Kiladjian, Jean‐Jacques, Buckley, Sarah, Derkach, Andriy, Roman‐Torres, Karisse, and Rampal, Raajit K.

Subjects
*OVERALL survival, *RUXOLITINIB, *MYELOFIBROSIS, *SPLEEN, *KINASE inhibitors
Abstract

ABSTRACT Spleen volume reduction (SVR) is a key endpoint in inhibitors of Janus kinase (JAK) inhibitor studies. Retrospective analyses have demonstrated an association between SVR and improved overall survival (OS) among patients treated with ruxolitinib with a platelet count > 100 × 109/L. Whether this association occurs in patients with thrombocytopenia is unclear. Pacritinib, a JAK2/IRAK1/ACVR1 inhibitor, demonstrated improved SVR versus best available therapy (BAT [best available therapy]; including ruxolitinib) in patients with myelofibrosis and platelet counts ≤ 100 × 109/L in the PERSIST‐2 study. Patients on study at the start of the 12‐week SVR window on pacritinib 200 mg twice daily or BAT were included. OS was evaluated among SVR responders versus non‐responders using different SVR thresholds (≥ 35%, ≥ 20%, ≥ 10%, and > 0%). Among patients on pacritinib (n = 89), SVR ≥ 10% demonstrated the greatest separation in OS curves between responders and non‐responders (HR, 0.00; 95% CI, 0.00–0.14; p < 0.01), though SVR ≥ 0% and SVR ≥ 20% were also associated with improved OS. No SVR threshold conferred OS benefit on BAT (n = 84), including ruxolitinib (n = 39). In patients with myelofibrosis and platelets ≤ 100 × 109/L, achieving SVR on pacritinib, but not BAT (including ruxolitinib), was associated with significant OS benefit, suggesting that pacritinib may offer a unique survival advantage in patients with myelofibrosis and thrombocytopenia who achieve any SVR.Trial Registration: ClinicalTrials.gov number: NCT02055781 [ABSTRACT FROM AUTHOR]

Published
2024
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42. Risk-adjusted safety analysis of pacritinib (PAC) in patients (pts) with myelofibrosis (MF)

Author

Pemmaraju, Naveen, Scott, Bart L., Savona, Michael R., Oh, Stephen T., Harrison, Claire, Vannucchi, Alessandro M., FRANCESCA PALANDRI, Al-Ali, Haifa Kathrin, Sobas, Marta, Mary, Frances Mcmullin, Gupta, Vikas, Mesa, Ruben A., Buckley, Sarah, Roman-Torres, Karisse, Verstovsek, Srdan, and Yacoub, Abdulraheem

Subjects
Cancer Research, Oncology
Abstract

7058 Background: PAC is a novel JAK2/IRAK1 inhibitor that has shown significant activity in pts with MF, including those with platelet (plt) counts 9/L. Recently, JAK inhibitors have come under increased scrutiny due to specific, emerging toxicities with drugs in this class. This safety analysis focuses on these toxicities of interest for pts treated with PAC 200 mg BID and best available therapy (BAT), including ruxolitinib (RUX), on the Phase 3 PERSIST-2 and Phase 2 PAC203 studies. Data are presented as risk-adjusted incidences to account for differential time at risk for adverse events (AEs) between arms due to cross-over. Methods: Pts treated with PAC 200 mg BID on PERSIST-2 and PAC203, and those treated with BAT on PERSIST-2, were included. Risk-adjusted AEs, representing event rate per 100 patient-years (pt-yrs), were calculated for overall and fatal AEs, bleeding AEs (determined by Standardized Medical Dictionary for Regulatory Activities Query [SMQ]), cardiac AEs (by SMQ), major cardiac events (per major adverse cardiovascular events [MACE] classification), infections, thromboses, and secondary malignancies. Results: A total of 160 pts were analyzed as the pooled PAC group (n=106 in PERSIST-2; n=54 in PAC203) and 98 pts in the BAT group (44 on RUX). At baseline, median plt count was 57×109/L; 61% had prior JAK2 inhibitor therapy. The rate of AEs was higher on PAC versus BAT, while the rate of fatal AEs was lower (Table). Both bleeding and cardiac events occurred at slightly lower rates on PAC compared to BAT. There were no MACE events on PAC, whereas there were on BAT. Malignant neoplasms occurred at similar rates on PAC and BAT, though rate of non-melanoma skin cancers was lower in pooled PAC (3/100 pt-yrs) versus BAT (7/100 pt-yrs), including RUX (11/100 pt-yrs). Infection occurred more frequently on PAC, though fungal and viral infections occurred less frequently, as did herpes zoster reactivation (pooled PAC: 0/100 pt-yrs vs BAT: 2.4/100 pt-yrs, including RUX: 5.5/100 pt-yrs). Thrombosis occurred at similar rates on PAC and BAT. Conclusions: Risk-adjusted analysis demonstrates that the safety profile of PAC 200 mg BID is comparable or superior to BAT, including RUX. PAC 200 mg BID may represent a full-dose therapeutic option for pts with MF, including those with thrombocytopenia. Clinical trial information: NCT02055781; NCT04884191. [Table: see text]

43. Retrospective analysis of pacritinib in patients with myelofibrosis and severe thrombocytopenia.

Author

Verstovsek S, Mesa R, Talpaz M, Kiladjian JJ, Harrison CN, Oh ST, Vannucchi AM, Rampal R, Scott BL, Buckley SA, Craig AR, Roman-Torres K, and Mascarenhas JO

Subjects
Bridged-Ring Compounds, Humans, Janus Kinase 2, Nitriles therapeutic use, Protein Kinase Inhibitors adverse effects, Pyrimidines, Retrospective Studies, Anemia chemically induced, Primary Myelofibrosis complications, Primary Myelofibrosis diagnosis, Primary Myelofibrosis drug therapy, Thrombocytopenia chemically induced, Thrombocytopenia etiology
Abstract

Thrombocytopenia is common in patients with myelofibrosis (MF) and is a well-established adverse prognostic factor. Both of the approved Janus kinase (JAK) inhibitors, ruxolitinib and fedratinib, can worsen thrombocytopenia and have not been evaluated in patients with severe thrombocytopenia (platelet counts <50×109/L). Pacritinib, a novel JAK2/interleukin-1 receptor-associated kinase 1 inhibitor, has been studied in two phase III trials (PERSIST-1 and PERSIST- 2), both of which enrolled patients with MF and severe thrombocytopenia. In order to better characterize treatment outcomes for this population with advanced disease, we present a retrospective analysis of efficacy and safety data in the 189 patients with severe thrombocytopenia treated in the PERSIST studies. The proportion of patients in the pacritinib group meeting efficacy endpoints was greater than in the BAT group for ≥35% spleen volume reduction (23% vs. 2%, P=0.0007), ≥50% modified Total Symptom Score reduction (25% vs. 8%, P=0.044), and self-reported symptom benefit ("much" or "very much" improved; 25% vs. 8%, P=0.016) at the primary analysis time point (week 24). The adverse event profile of pacritinib was manageable, and dose modification was rarely required. There was no excess in bleeding or death in pacritinib-treated patients. These results indicate that pacritinib is a promising treatment for patients with MF who lack safe and effective therapeutic options due to severe thrombocytopenia.

Published
2022
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