Two-drug combo shown to significantly shrink breast cancer in days
pharmafile | March 10, 2016 | News story | Medical Communications, Research and Development | GSK, Herceptin, Novartis, Roche, Tyverb
Results of a clinical trial have revealed that Novartis’ Tyverb (lapatinib), in combination with Roche’s Herceptin (trastuzumab), can significantly shrink HER2-positive breast cancers, just 11 days after diagnosis.
The results of the five-year, multicentre Phase III EPHOS-B study, revealed today at European Breast Cancer Conference in Amsterdam. Professor Nigel Bundred, from The University of Manchester, presented data from the trial of 257 women with newly-diagnosed, operable, HER2-positive disease, showing approximately a quarter of these women treated with the Tyverb/Herceptin combo before surgery saw their tumours rapidly shrink significantly or even disappear. This was noted as significant in that it could allow these patients to avoid chemotherapy.
The human epidermal growth factor receptor 2 (HER2) protein is believed to play a role in the development of breast cancer. The protein can affect the growth of some cancer cells; extra HER2 receptors stimulate the cancer cells to divide and grow, and where this protein is present in higher levels, the cancer is defined as HER2-positive.
Doctors often treat HER2-positive breast cancer surgically, followed by chemotherapy and then Herceptin – which research shows can lower the risk of the cancer returning after surgery. The trial aimed to prove that blocking the HER2 protein before surgery can further decrease this risk.
Baroness Delyth Morgan, chief executive at Breast Cancer Now, says: “We hope this particularly impressive combination trial will serve as a stepping stone to an era of more personalised treatment for HER2 positive breast cancer.
“Such a rapid response to treatment with Herceptin and Tyverb before surgery could soon give doctors the unprecedented ability to identify women responding so well to combined HER2-targeting drugs that they would not need gruelling chemotherapy.
“To confirm these hopes, we’ll now need to see the results replicated in larger trials and to understand how such a positive response to combined HER2-targeted drugs before surgery – and the avoidance of chemotherapy – could impact on survival.”
Novartis gained Tyverb in 2014’s multi-billion asset swap with GSK. Novartis took GSK’s cancer portfolio in exchange for its vaccines business in a complex deal. GSK is listed as a sponsor of the EPHOS-B trial.
Tyverb is marketed as Tykerb in the US and Canada. Its development suffered a major setback in 2014 when it failed a major late-stage breast cancer trial, comparing it in combination with Herceptin to Herceptin alone, in patients who had already undergone surgery. However, the combo now appears to have found a niche in the pre-surgery environment.
Joel Levy
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