Kazia Therapeutics provides update from Phase 2 clinical trial of paxalisib

Kazia Therapeutics provided a preliminary update from the ongoing investigator-initiated Phase 2 clinical trial, or NCT04906096, evaluating paxalisib as monotherapy treatment in patients with relapsed/refractory primary central nervous system lymphoma, or r/r PCNSL. This is an open-label, Phase 2 clinical trial, led by Lakshmi Nayak, of the Dana-Farber Cancer Institute in Boston, MA. Eligible patients with r/r PCNSL will be administered paxalisib as monotherapy for up to 24 months, in an initial dosing regimen of 60mg daily, which is similar to the dosing regimen used for paxalisib clinical trials in other adult brain cancers. The objectives of the study are to assess the clinical efficacy and safety of paxalisib in up to twenty-five patients with r/r PCNSL based on objective response rate, or ORR, duration of response, or DOR, progression-free survival, or PFS, and overall survival, or OS. To date, fourteen patients have been enrolled in the study. Clinical activity has been preliminarily observed in enrolled patients, including partial responses and stable disease. Although early clinical activity was observed in some patients, several heavily pretreated r/r PCNSL patients experienced treatment-related adverse events consistent with those previously reported with paxalisib, that resulted in dose reductions and, in some cases, early termination from the study. As such, the protocol is being optimized by the investigator to initiate starting doses at 15mg twice a day or 30mg once a day with the goal of improving the durability of clinical benefit and overall tolerability.