GlaxoSmithKline's Tykerb/Tyverb and chemotherapy combo fails in gastric cancer

UK pharma giant GlaxoSmithKline (LSE: GSK) says that its study of Tykerb/Tyverb (lapatinib) in combination with chemotherapy in patients with HER2-positive advanced gastric cancer did not meet the primary endpoint of improved overall survival (OS) compared to chemotherapy alone.

The median OS for patients in the lapatinib plus chemotherapy group was 12.2 months compared to 10.5 months for patients randomized to placebo plus chemotherapy (HR=0.91; 95% CI: 0.73, 1.12; p=0.3492). There were no new safety signals identified in this trial.

This was a randomized, double-blinded Phase III study of lapatinib in combination with chemotherapy (oxaliplatin and capecitabine) compared to chemotherapy plus placebo in patients with HER2-positive advanced gastric cancer in the first line treatment setting. The primary endpoint was overall survival and secondary endpoints 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.