Puma's neratinib 'graduates' from I-SPY2
Puma Biotechnology Inc. (NYSE:PBYI) said a regimen containing the company's neratinib "graduated" from the open-label I-SPY 2 trial based on having a high probability of success in patients with HER2-positive/hormone receptor-negative breast cancer in a Phase III trial. The company said that as far as it knows, the neratinib-containing regimen is the first to graduate from I-SPY 2, which is designed to rapidly and inexpensively develop data to support small Phase III trials of new neoadjuvant therapies for locally advanced breast cancer or to help companies quickly kill ineffective candidates. The trial involves an adaptive trial design based on Bayesian predictive probability that a regimen will be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial.
Puma said neratinib is now eligible for the upcoming Phase III I-SPY 3 trial, which is likely to start next year. Puma has exclusive, worldwide rights to develop and commercialize the oral inhibitor of HER1, HER2 and HER4 kinases from Pfizer Inc. (NYSE:PFE). Earlier this year Puma began a Phase III trial of neratinib in third-line breast cancer. ...