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MPN Workshop of the Carolinas 2024 | Final results of a Phase II study of add-on parsaclisib for pts with MF and suboptimal rux response

Abdulraheem Yacoub, MD, University of Kansas Medical Center, Kansas City, KS, presents the final results of a Phase II study (NCT02718300) investigating add-on parsaclisib, a phosphoinositide 3-kinase (PI3K) inhibitor, for patients with myelofibrosis (MF) and a suboptimal response to optimized ruxolitinib (rux) therapy. Although the addition of this agent showed clinical benefit in the Phase II trial, subsequent Phase III studies did not meet their primary endpoints. This interview took place at the 1st Annual MPN Workshop of the Carolinas in Asheville, NC.

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Transcript

So parsaclisib is a PI3K inhibitor that was designed and studied in multiple blood cancers, and was the only PI3K inhibitor of its class that was studied in myelofibrosis. The first prospective study was the Phase II study that was published in Blood Advances that showed the addition of parsaclisib to select patients with myelofibrosis who are on optimized ruxolitinib dose and continue to have disease burden, as measured by enlarged spleens and high symptoms, that the addition of parsaclisib in these patients resulted in further clinical benefit, more spleen reduction and more symptom improvement, and more clinical benefit...

So parsaclisib is a PI3K inhibitor that was designed and studied in multiple blood cancers, and was the only PI3K inhibitor of its class that was studied in myelofibrosis. The first prospective study was the Phase II study that was published in Blood Advances that showed the addition of parsaclisib to select patients with myelofibrosis who are on optimized ruxolitinib dose and continue to have disease burden, as measured by enlarged spleens and high symptoms, that the addition of parsaclisib in these patients resulted in further clinical benefit, more spleen reduction and more symptom improvement, and more clinical benefit.

So we were very glad with the results from the Phase II study. However, the combination of parsaclisib was taken to Phase III studies and unfortunately those studies did not meet their planned endpoints, and at this point, this drug is not under development for myelofibrosis.

 

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Disclosures

Consultancy: Novartis, CTI Pharma, Incyte, Pfizer, Acceleron Pharma, Pharmaessentia.