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news.GlaxoSmithKline's (GSK) Phase III study designed to assess Tykerb/Tyverb (lapatinib) in combination with chemotherapy for advanced HER2-positive gastric cancer has failed to meet the primary endpoint of improved overall survival (OS) against chemotherapy alone.
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The trial did not discover new safety signals, while the median OS for patients in the lapatinib and chemotherapy group was 12.2 months against 10.5 months for patients in the placebo plus chemotherapy.
Secondary endpoints of the randomized, double-blinded study, were progression-free survival (PFS), response rate and duration of response.
Median PFS was 6.0 months, response rate was 53% and the duration of response was 7.3 months in the investigational combination chemotherapy group compared to median PFS of 5.4 months, response rate of 39% and duration of response of 5.6 months for patients in chemotherapy alone group.
Diarrhoea, vomiting, anemia, dehydration and nausea were serious adverse events (SAE) reported in over 2% of patients in the investigational combination chemotherapy group, while vomiting was the most common SAE noted in the chemotherapy group.