GSK’s Tyverb fails late-stage trial in breast cancer
pharmafile | December 12, 2011 | News story | Research and Development, Sales and Marketing | GSK, Tyverb, breast cancer
GlaxoSmithKline’s Tyverb has failed to help women with HER2 positive breast cancer increase their survival.
The TEACH study’s primary objective was to compare disease-free survival between women receiving Tyverb (lapatinib) and those being treated with placebo.
The drug was given to women diagnosed with HER2 positive breast cancer, who had received neo-adjuvant or adjuvant chemotherapy – but not Roche’s Herceptin (trastuzumab) – and remained disease free.
In results presented at the 2011 CRTC-AACR San Antonio Breast Cancer Symposium, GSK said improvement in DFS did ‘not reach statistical significance’.
This is the second time in recent months that Tyverb has come up short: in September, GSK halted one of the four Phase III studies that make up the ALTTO programme which is designed to evaluate the brand against Herceptin in early breast cancer following surgery.
GSK found then that Tyverb alone was unlikely to demonstrate non-inferiority to Herceptin with respect to DFS.
In TEACH, more than 3,000 women were randomised to receive Tyverb or placebo for up to 12 months or until a DFS event – disease recurrence, a second primary cancer, contralateral breast cancer or death from any cause – occurred.
After a median follow up of four years, DFS events occurred in 13% of patients in the Tyverb arm and 17% in the placebo arm of the trial.
Rafael Amado, GSK senior vice president of oncology development, admitted that the company was ‘disappointed’.
In Europe the drug is licensed, in combination with an aromatase inhibitor, for the treatment of post-menopausal women with hormone receptor (HR)-positive, HER2 (ErbB2) over-expressing metastatic breast cancer and for whom chemotherapy is currently not intended.
It is also approved in combination with Roche’s Xeloda (capecitabine) for advanced or metastatic breast cancer whose tumours over-express HER2 and who have received prior therapy including an anthracycline, a taxane, and Herceptin.
Amado added that Tyverb remains an important treatment option for patients whose disease has progressed on treatment with trastuzumab-based regimens.
Clinical trials are ongoing with Tyverb in different combinations and lines of therapy, including the adjuvant setting.
Adam Hill
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