Puma Biotech's Neratinib Fails To Extend Overall Survival In Brain Cancer Trial

Puma Biotechnology Inc PBYI announced interim data from the neratinib arm of Phase 2 INSIGhT Trial in newly diagnosed unmethylated glioblastoma with IDH R132H mutation-negative.
In the intent-to-treat population, progression-free survival (PFS) was not significantly longer with neratinib (median 6.0 months) versus the control arm (median 4.7 months).
Also, there was no significant improvement in overall survival (OS) between neratinib (median 13.8 months) vs. the control arm (14.7 months).
For patients with activation of the EGFR pathway, PFS was significantly longer with neratinib (median 6.3 months) vs. the control arm (4.6 months).
However, there was no significant improvement in OS between neratinib (median 14.4 months) vs. the control arm (15.3 months).
Neratinib was generally well-tolerated in the trial, and toxicities for neratinib were similar to those previously described.
For the 81 patients treated with neratinib, there were 6 cases (7.4%) of grade 3 diarrhea and no cases of grade 4 diarrhea. No new toxicity signals were identified in the trial.
Related: Puma Biotech's Nerlynx Wins Canadian Approval In HER2-Positive Metastatic Breast Cancer.
Price Action: PBYI shares closed at $3.42 on Friday.