GSK’s Tykerb Fails to Meet Trial Targets
GlaxoSmithKline has suffered a setback from the news that Tykerb has failed a late-stage trial investigating whether adjuvant treatment with the drug improves disease-free survival in women with early-stage HER2 positive breast cancer.
Results have been presented at the San Antonio Breast Cancer Symposium from TEACH (Tykerb Evaluation After Chemotherapy), a Phase III randomised, double-blind, placebo-controlled, study designed to assess the effects of Tykerb/Tyverb (lapatinib) monotherapy when given to women who were diagnosed with HER2 positive breast cancer, and had received treatment, but not Roche’s rival drug Herceptin (trastuzumab), and remained disease free.
The principal objective of the trial, which involved over 3,000 women, was to compare disease-free survival (DFS) between women receiving Tykerb and those receiving the placebo. The median time from diagnosis to study entry was 3 years. Use of Tykerb in the delayed adjuvant setting is investigational only and not approved by regulatory authorities anywhere in the world. After a median follow-up of four years, DFS events occurred in 13% of patients in the Tykerb arm and 17% on placebo.
Rafael Amado, Senior Vice President of the Oncology Department at GSK, commented that “although we are disappointed that the improvement in DFS with Tykerb monotherapy in TEACH did not reach statistical significance”, combination therapy with Tykerb “remains an important treatment option for patients with metastatic Her2+ breast cancer whose disease has progressed on treatment with trastuzumab-based regimens”.
In addition, he added that “we look forward to the results from on-going clinical trials with Tykerb in different combinations and lines of therapy, including the adjuvant setting”. Tykerb was initially approved for use in combination therapy in the metastatic setting in 2007, and is currently available in 107 different countries. The nine-month sales of the drug were up 3% to £172 million.