Roche’s new breast cancer drug succeeds in late-stage trial
pharmafile | December 9, 2011 | News story | Research and Development, Sales and Marketing | Roche, breast cancer, pertuzumab
Roche’s next generation breast cancer drug pertuzumab has helped patients to live over six months longer.
CLEOPATRA, the first randomised Phase III study of the drug, showed a 6.1 month improvement in median progression free survival (PFS), from 12.4 to 18.5 months in HER2-positive metastatic breast cancer.
The study set a combination of pertuzumab, Roche’s own Herceptin (trastuzumab) and docetaxel chemotherapy, against Herceptin and docetaxel in patients who had been previously untreated.
Hal Barron, Roche’s chief medical officer, said: “We have been studying the HER2 pathway for 30 years to bring personalised medicines to people with HER2-positive breast cancer.
“These results show we may soon improve on the current standard of care, Herceptin plus chemotherapy,” he added.
Pertuzumab and Herceptin are thought to work well together because they both bind to the HER2 receptor but on different regions, which means they may block HER signalling pathways more comprehensively.
In September, Roche’s other breast cancer drug trastuzumab emtansine (T-DM1) impressed at the European cancer congress, after besting Herceptin in a new study.
In the Phase II trial patients with HER2-positive metastatic breast cancer who received T-DM1 rather than Herceptin plus docetaxel, experienced a 41% reduction in the risk of their disease worsening or death.
They also lived a median of five months longer without their disease worsening (PFS 14.2 months against 9.2 months).
Offsetting Avastin losses
Potential breakthroughs such as this and CLEOPATRA would be welcome at any time, but these could be particularly important to the Swiss pharma firm after a difficult period in which one of its key drugs, Avastin (bevacizumab), has run into choppy waters.
While it remains the biggest selling cancer treatment in the world, making $6.5 billion last year, that figure is expected to be down $1 billion after the FDA pulled its breast cancer licence in the US, because the drug failed to prove its safety and efficacy for this indication.
The regulator said women taking it for metastatic breast cancer risk potentially life-threatening side effects, without proof that the use of Avastin will provide a benefit in terms of delay in tumour growth.
However, Roche has not been idle in the face of these difficulties, looking to offset this loss with a new licence for Avastin in ovarian cancer, which analysts believe could bring in around $1 billion in peak annual sales.
European regulators have been less concerned, restricting Avastin’s use with just one form of chemotherapy in Europe, saying that it believed Avastin could still be beneficial in this setting.
Adam Hill
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