Athenex presents updated phase III data on survival and tolerability associated with oral paclitaxel and encequidar in patients with metastatic breast cancer
RCT (n=402) showed benefit in secondary endpoints of progression free survival (8.4 vs. 7.4 months, HR 0.739; 95% CI. 0.561-0.974; p=0.023) and overall survival (23.3 vs. 16.3 months, 0.735; 0.556-0.972; p=0.026) for oral paclitaxel + encequidar vs. approved IV paclitaxel regimen
Source:
Biospace Inc.
SPS commentary:
The trial was designed to demonstrate superiority of oral paclitaxel over approved IV paclitaxel regimen on the primary end point of overall response rate; it was not powered to demonstrate superiority of oral paclitaxel on the secondary survival endpoints
Oral paclitaxel and encequidar is the first oral formulation of paclitaxel in late-stage development for the treatment of metastatic breast cancer. Encequidar is a highly specific and potent inhibitor of P-glycoprotein (P-gp) in the gastrointestinal tract. By localizing P-gp inhibitory activity, encequidar improves the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body.