CTI BioPharma Presents Pivotal Data from Pacritinib Program

 CTI BioPharma Corp. (Nasdaq: CTIC) today announced a poster presentation from the Company's pacritinib program at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago and virtually, June 3-7, 2022.

"These data reinforce pacritinib's role as a safe, differentiated JAK inhibitor. Our risk-adjusted analysis demonstrates that the safety profile of pacritinib 200 mg twice a day is comparable to best available therapy, including ruxolitinib, and that pacritinib 200 mg twice daily could be a full-dose therapeutic option for patients with myelofibrosis, including those who experience severe thrombocytopenia," said Adam Craig, President and Chief Executive Officer of CTI BioPharma. "Earlier this year, VONJOTM (pacritinib) at 200 mg orally twice daily received accelerated FDA approval, becoming the first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis. The NCCN® Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms also recently included VONJO as a recommended first- and second-line treatment. With a successful beginning to our commercial launch, these data reinforce VONJO's value as a new standard of care for cytopenic myelofibrosis patients with platelet counts <50 × 109/L who have been waiting for new treatment options."

Presentation materials will be available at ctibiopharma.com.

Risk-adjusted safety analysis of pacritinib in patients with myelofibrosis (ASCO Poster #7058)

Pacritinib is a novel JAK2/IRAK1 inhibitor that has shown significant activity in patients with myelofibrosis, including those with platelet counts <50 × 109/L. This safety analysis focuses on toxicities of interest for patients treated with pacritinib 200 mg twice daily (BID) and best available therapy (BAT), including ruxolitinib, on the Phase 3 PERSIST-2 and Phase 2 PAC203 studies. Because the average treatment duration was longer for patients on pacritinib 200 mg BID on PERSIST-2 and PAC203 compared to BAT on PERSIST-2, this analysis presents adverse events rates in these patients corrected for duration of exposure.

This risk-adjusted analysis demonstrates that the safety profile of pacritinib 200 mg BID is comparable to BAT. In particular, rates of bleeding were not elevated on pacritinib 200 mg BID compared to BAT, both overall and in patients with PLT <50 x 109/L. Rates of fatal events, thrombosis, major adverse cardiac events (MACE) and non-melanoma skin cancer were higher on ruxolitinib than pacritinib. These results indicate that pacritinb 200 mg BID may represent a full-dose therapeutic option for patients with myelofibrosis, including those with thrombocytopenia.

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