PBYI - Puma Bio reports neratinib arm data from Phase II INSIGhT trial at 2021 SNO Meeting

Puma Biotechnology (NASDAQ:PBYI) presents results from the neratinib arm of the Phase II INSIGhT Trial at the 2021 Society for Neuro-Oncology (SNO) Annual Meeting. PBYI shares up 11.4% premarket at $3.81. The INSIGhT trial is a Phase II screening adaptive platform trial where patients with newly diagnosed unmethylated glioblastoma are given radiation therapy and temozolomide and then are randomized to receive either adjuvant temozolomide or adjuvant treatment with an experimental agent (neratinib). The primary endpoint of INSIGhT is overall survival (OS). Progression-free survival (PFS) analysis is used to influence randomization. For the neratinib arm of the trial, there were 149 patients in the intent-to-treat population, including 81 patients treated with neratinib and 68 patients in the control arm. For the intent-to-treat population, PFS was not significantly longer (HR 0.75; p=0.12, log rank test) with neratinib (median 6.0 months) versus the control arm (median 4.7 months) and there was no significant

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Puma Bio reports neratinib arm data from Phase II INSIGhT trial at 2021 SNO Meeting