Puma Biotech's Neratinib Fails To Extend Overall Survival In Brain Cancer Trial
- Puma Biotechnology Inc (NASDAQ: 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.
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