Incyte stops PhIII trial for PI3K inhibitor after primary endpoint failure
Incyte has called it quits on a Phase III study for its oral PI3K inhibitor, parsaclisib, a year after withdrawing its accelerated approval pitch for a different indication.
The study was looking at parsaclisib plus ruxolitinib versus a placebo plus ruxolitinib in myelofibrosis (MF) patients 18 years and older who had an “inadequate” response to ruxolitinib monotherapy. MF is a rare, chronic blood cancer that affects the bone marrow and the production of blood cells.
But Delaware-based Incyte said in a press release that after an interim analysis of the data, it determined the LIMBER-304 study was “unlikely” to hit the primary endpoint: reduction in spleen volume. Secondary endpoints included overall survival, number of adverse events and the time of onset of targeted reduction in spleen volume.
According to the company’s website, parsaclisib is also being looked at in warm autoimmune hemolytic anemia.
The LIMBER program was evaluating monotherapy and combinations of drugs to improve and expand treatments for patients with myeloproliferative neoplasms and graft-versus-host disease.
Last year, Incyte withdrew a submission for accelerated approval of parsaclisib for the treatment of relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma, saying the confirmatory studies “cannot be completed within a time period that would support the investment.”
PI3K inhibitors have received increased scrutiny since the FDA first approved Novartis’ Piqray to treat a particular type of breast cancer in 2019. Last year, Novartis’ PI3K inhibitor alpelisib (branded Vijoice) got the FDA greenlight for the drug in PIK3CA-related overgrowth spectrum (PROS).
An FDA adcomm in April last year voted that all approvals for PI3K inhibitors should be supported by randomized data to support risk-benefit evaluations in patients with blood cancers. PI3K inhibitors also garnered more attention in hematological malignancies after toxicity concerns, inadequate dose optimization, trial design limitations of single-arm studies and concerning overall survival trends.
