Athenex (ATNX -29.9%) slumps on more than triple normal volume following its release of topline data from a Phase 3 clinical trial evaluating oral paclitaxel (Oraxol) compared to the intravenous formulation (Taxol or generic) in patients with metastatic breast cancer.
The primary endpoint was the overall response rate (ORR) at weeks 19 and 22. The ORR in the oral arm was 36% versus 24% in the IV arm (no pun intended) (p=0.01).
At the data cutoff on July 25, the separations in progression-free survival and overall survival favored oral paclitaxel but the effects were not statistically significant.
On the safety front, the incidence of neuropathy was much less in the oral group (17% vs. 57%) as was Grade 3 (intolerable burning/prickling sensation) neuropathy (1% vs. 8%). Other treatment-related adverse events also favored oral paclitaxel, but the incidence of life-threatening neutropenia and infection was higher than the IV group as was the rate of gastrointestinal side effects.
The company says it will prepare a U.S. marketing application as soon as possible.
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