Roche’s Herceptin successor impresses at EMCC
pharmafile | September 27, 2011 | News story | Research and Development | Herceptin, Roche, TDM-1
Roche’s next-generation breast cancer drug T-DM1 has impressed at the European cancer congress after besting Herceptin in a new study.
The new phase II trial compared trastuzumab emtansine (T-DM1) to Roche’s established HER2-positive breast cancer drug Herceptin (trastuzumab) plus docetaxel chemotherapy.
The results showed that patients with HER2-positive metastatic breast cancer who received T-DM1 experienced a 41% reduction in the risk of their disease worsening or death, and lived a median of five months longer without their disease worsening (PFS 14.2 months against 9.2 months).
In addition, people who received T-DM1 had only half the serious adverse events compared to those on the Herceptin plus chemotherapy arm.
No overall survival data has yet been published, but there will be more data for the drug next year.
Hal Barron, head of global product development at Roche, said the study of T-DM1 was very exciting.
“We believe this investigational antibody-drug conjugate approach, in which chemotherapy is attached to the antibody and selectively delivered to tumour cells, is an important potential weapon for fighting cancer and we look forward to the phase III study results with trastuzumab emtansine,” he said.
T-DM1 uses a new, targeted antibody that can kill breast cancer cells at a later stage of the disease after the failure of other chemotherapy and cancer drugs.
It is designed to target and inhibit HER2 signalling and deliver the chemotherapy directly inside HER2-positive cancer cells.
Currently around 25% of breast cancer cases are positive for the HER2 mutation. It is this protein that is targeted by Herceptin, which made Roche CHF 5.4 billion in sales last year.
The drug latches on to HER2, interfering with it without killing the cell, but it must be given with chemotherapy.
What T-DM1 does differently is attach trastuzumab and the chemotherapy DM1 together using a stable linker that is designed to keep trastuzumab emtansine in one piece until it reaches specific cancer cells.
Sara Hurvitz, director of the breast oncology programme at the University of California, told Bloomberg: “Herceptin is like a bullet without a gun. Unfortunately we have to give it with chemotherapy, and this [using T-DM1] really is the ideal way to do it.”
The drug could make more than CHF1 billion ($1.1 billion) in peak annual sales, according to a company presentation at the congress, and adds to an impressive pipeline of cancer drugs for the company.
There are currently ongoing phase III trials for the drug – MARIANNE, EMILIA and TH3RESA – which will compare T-DM1 with GSK’s Tyverb and Roche’s own Xeloda, as well as in other settings.
Herceptin is set to go off patent in Europe by 2015 and Roche will aim to get T-DM1 approved in time to help offset this loss.
Ben Adams
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