Herceptin successor impresses at ASCO
pharmafile | June 6, 2012 | News story | Research and Development, Sales and Marketing | ASCO, Cancer, EMILIA, FDA, Roche, T-DM1
Roche’s new ‘smart bomb’ breast cancer drug T-DM1 has impressed at this year’s ASCO conference in Chicago.
The trial showed it significantly delayed disease progression in metastatic HER2 positive breast cancer and produced fewer side effects.
The Phase III EMILIA study showed of trastuzumab emtansine (T-DM1) reduced the risk of disease worsening or death was reduced by 35% compared to GSK’s Tyverb (lapatinib) plus Roche’s Xeloda (capecitabine).
T-DM1 combines Herceptin and chemotherapy in one molecule, which allows the chemo to be targeted only at cancer cells. This makes the treatment more effective and spares patients the side-effects of traditional chemotherapy, where healthy cells are also killed.
Roche plans to submit the drug in HER2-positive mBC this year to the EMA and the FDA.
The drug could make more than $1.1 billion in peak annual sales, according to analysts. Herceptin currently earns over $6 billion a year, but will go off from 2015.
The EMILIA study is the first randomised Phase III trial of trastuzumab emtansine in patients with HER2-positive mBC who had previously received Herceptin (trastuzumab) and taxane chemotherapy.
Patients who received T-DM1 also had an increase in overall survival – the other co-primary endpoint of the study – compared to those who received Tyverb plus Xeloda.
But Roche said these data were not yet mature, and would release them at a later date.
The firm also said that patients taking T-DM1 had fewer severe adverse events compared to those who received Tyverb plus Xeloda (40.8% compared to 57 per cent).
Hal Barron, head of global product development at Roche, said: “We are working with global regulatory authorities to submit these data as quickly as possible and hope that trastuzumab emtansine will soon be available to patients with this aggressive type of breast cancer.”
The EMILIA data was presented at the 48th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago this week.
The ASCO conference highlights new data from emerging and standard oncology treatments, and is seen as a showcase for the most exciting cancer treatments.
‘Smart bomb’ mode of action
T-DM1 uses a new, targeted antibody that can kill breast cancer cells even at a later stage of the disease after other chemotherapy and cancer drugs no longer work.
It is designed to target and inhibit HER2 signalling and delivers the chemotherapy directly inside HER2-positive cancer cells a process known as a ‘smart bomb’.
Around 25% of breast cancer cases are positive for the HER2 mutation, which is targeted by Herceptin.
Ben Adams
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