GSK’s gastric cancer drug fails to meet primary endpoint in phase 3

GSK's advanced gastric cancer drug did not meet the primary endpoint of overall survival compared to chemotherapy alone in phase 3 clinical trials.

The company announced that its study of Tykerb (in the US) / Tyverb (Europe) (lapatinib) in combination with chemotherapy in patients with HER2-positive advanced gastric cancer showed that the median overall survival rate for patients in the lapatinib plus chemotherapy group was 12.2 months compared to 10.5 months for patients randomised to placebo plus chemotherapy.

Secondary endpoints for this clinical trial included progression-free survival, response rate and duration of response. Median progression-free survival for patients in the lapatinib plus chemotherapy group was 6.0 months and 5.4 months for those in the chemotherapy alone group. Response rate was 53% for patients in the lapatinib plus chemotherapy group and 39% for those in the chemotherapy alone group. In the lapatinib plus chemotherapy group, the duration of response was 7.3 months compared to 5.6 months in the placebo plus chemotherapy group.

Tykerb / Tyverb is not approved or licensed anywhere in the world for the treatment of HER2-positive advanced gastric cancer. It is approved for the treatment of breast cancer and some other solid tumours.