GlaxoSmithKline has reported positive results from Phase III study evaluating investigational combination Tykerb (lapatinib) plus paclitaxel in patients with in HER2-positive advanced breast cancer.
The results showed that women with previously untreated HER2-positive metastatic breast cancer achieved a statistically significant improvement in overall survival when treated with lapatinib plus paclitaxel, compared to those treated with paclitaxel plus a placebo.
Women receiving lapatinib plus paclitaxel experienced an overall survival of 27.8 months, compared to 20.5 months in women receiving paclitaxel plus placebo.
The study also demonstrated a statistically significant improvement in median progression-free survival for women treated with the lapatinib plus paclitaxel regimen (9.7 months) compared to the placebo-containing regimen (6.5 months).
Women receiving lapatinib plus paclitaxel had a response rate of 69%, compared to 50% in the paclitaxel plus placebo group.
The study’s primary endpoint was overall survival, while the secondary endpoints included progression-free survival, overall response rate, clinical benefit response rate, duration of response, time to response and safety.
The study enrolled 444 patients who were randomised to receive once-daily lapatinib plus weekly paclitaxel or weekly paclitaxel plus placebo.
