- In a 479-patient Phase 2 clinical trial, Puma Biotechnology's (NASDAQ:PBYI) tyrosine kinase inhibitor, PB272 (neratinib), with paclitaxel demonstrated comparable results to Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) plus paclitaxel as a first-line treatment in patients with HER2-positive locally recurrent or metastatic breast cancer.
- The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and the incidence of central nervous system (CNS) metastases, including metastases of the brain.
- PFS and ORR for the neratinib/paclitaxel arm were 16.6 months and 74.8%, respectively versus 16.7 months and 75.1%, respectively for the trastuzumab/paclitaxel arm. The differences were not statistically significant.
- There was a 52.6% reduction in CNS metastases in the neratinib/paclitaxel group compared to the trastuzumab/paclitaxel group (7.4% vs. 15.6%) (p=0.006). The difference was statistically significant.
- The safety results showed a 30% incidence of grade 3 diarrhea in the neratinib/paclitaxel arm compared to 4% in the trastuzumab/paclitaxel arm. When high dose loperamide was administered in another trial, though, the incidence of grade 3 diarrhea dropped to 8% in patients receiving neratinib as monotherapy.
- The results of the study will be presented at a future scientific meeting.
- PBYI is down 7.9% after hours on average volume.