BioCentury
ARTICLE | Clinical News

Puma falls after breast cancer miss

November 15, 2014 3:21 AM UTC

Puma Biotechnology Inc. (NYSE:PBYI) lost $23.27 (10%) to $216.22 on Friday after its neratinib ( HKI-272, PB272) missed both the primary endpoint of improving progression-free survival (PFS) and the secondary endpoint of objective response rate (ORR) in the Phase II NEfERTT trial. The study compared neratinib with Herceptin trastuzumab from the Genentech Inc. subsidiary of Roche (SIX:ROG; OTCQX:RHHBY) as a first-line treatment for ErbB-2-positive locally recurrent or metastatic breast cancer.

Among the trial's 479 patients receiving one of the two drugs plus paclitaxel, PFS was 16.6 months for the neratinib group vs. 16.7 months for the trastuzumab group (p=0.35). ORR was 74.8% for neratinib and 75.1% for trastuzumab (p=0.94). Neratinib did meet a secondary endpoint of significantly reducing CNS metastases compared with trastuzumab (7.4% vs. 15.6% incidence, p=0.006). Puma expects to present full results at a scientific meeting next year. ...