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news.Biotechnology company Progen has said that the results of a Phase II trial administering 250mg of PI-88 in combination with docetaxel to patients with advanced non small cell lung cancer did not meet its primary and secondary endpoints of significantly improving the progression-free rate at six months compared to docetaxel alone.
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Progen said the overall data from this trial suggests that no further investigation of PI-88 in combination with docetaxel in patients with non small cell lung cancer that have failed platinum based first line therapies is warranted. However, nine patients in the study switched to PI-88 after experiencing toxicity or disease progression with docetaxel monotherapy. The data for this patient group suggests a potential survival benefit that Progen intends to investigate further with, amongst others, the clinicians involved in this study.
Justus Homburg, Progen’s CEO said: “They are disappointed, first and foremost, for the patients with non small cell lung cancer that have disease progression following platinum based chemotherapy as treatment options are limited, the outcome of this study has no impact on their Phase III registration strategy for patients with post-resection liver cancer which they announced has been granted fast-track status designation by the FDA.”
Mr Homburg also said: “It is quite common for new drugs to show benefit in one patient group but limited benefit in another. To date, PI-88 has shown evidence of benefit in patients with melanoma, multiple myeloma and post-resection liver cancer. In particular, PI-88 may be more active for tumors that are at an earlier disease stage, such as has been demonstrated in the PI-88 phase II primary liver cancer trial”.