Puma Biotechnology Announces Initial Results From Phase 2 Trial For PB272

(RTTNews) - Puma Biotechnology, Inc. (PBYI) Monday said efficacy results from a phase 2 clinical trial for lung cancer drug PB272 showed that, for the 13 patients who were on the drug alone and not in combination with temsirolimus, 7 achieved stable disease and 4 achieved clinical benefit.

PB272, or neratinib, is Puma's investigational drug for treating non-small cell lung cancer with HER2 mutations.

For the 14 patients on neratinib as well as temsirolimus, 11 achieved stable disease, 3 achieved a partial response, and 9 achieved clinical benefit.

"The activity seen to date in the trial confirms the efficacy signal seen in the prior Phase I trial and supports future study," said CEO Alan Auerbach.

Puma said the median progression-free survival for those on neratinib alone was 2.9 months and for those on neratinib as well as temsirolimus 4 months.

The company further said that to control the most frequent side-effect of neratinib, diarrhea, it gave all the patients high-dose Imodium. It found that only 1 patient in the neratinib-only category experienced grade 3 diarrhea and 2 patients receiving both neratinib and temsirolimus experienced grade 3 diarrhea.

But the company added that of the three patients, two were not taking Imodium at the onset of grade 3 diarrhea.