Drug news

Phase III study of Tyverb/Tykerb (Glaxo Smith Kline) fails to meet endpoint for Gastric Cancer

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Last updated:8th Jun 2013

Published:8th Jun 2013

Source: Pharmawand

A study of Tyverb/Tykerb (lapatinib ditosylate), from Glaxo Smith Kline, 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. This was a global, randomised, multicentre, double-blinded, Phase III study comparing the efficacy and tolerability of lapatinib in combination with oxaliplatin and capecitabine to oxaliplatin, capecitabine and placebo in subjects with HER2-positive advanced Gastric Cancer in the first line treatment setting.

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. The median OS for patients in the lapatinib plus chemotherapy group was 12.2 months compared to 10.5 months for patients randomised to placebo plus chemotherapy. There were no new safety signals identified in this trial.

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