Avastin sees success in brain cancer trial
pharmafile | August 13, 2012 | News story | Research and Development, Sales and Marketing | R&D, avastin, brain cancer
A late-stage study has shown that Roche’s oncology drug Avastin, when added to standard therapy, can help people with brain cancer live longer without the disease getting worse.
In the Phase III AVAglio trial the combination of Avastin, plus radiation and temozolomide chemotherapy, the drugs met the co-primary endpoint by improving progression-free survival in people with glioblastoma (GBM).
Roche says the AVAglio data will be presented at an upcoming medical meeting and information on final overall survival, the trial’s other endpoint, should be available next year.
Hal Barron, Roche’s chief medical officer, said the trial proved that patients ‘lived significantly longer’ (versus those treated with radiation, temozolomide and placebo) without their cancer worsening.
The Swiss firm says it is to discuss the findings with US and European regulators: Avastin is currently approved as a second line treatment in the US for glioblastoma as a single agent, but has no licence for that indication in Europe after the EMA found it had little benefit.
It will be looking to extend its US licence to become a first line treatment from this study, and also hope that the data could go some way to persuading the EMA that its drug works for this patient population.
Avastin made over $6 billion last year, and also has licences to treat kidney and lung cancers. But the drug’s sales have dipped in the past 12 months after the FDA revoked its breast cancer licence last year, wiping off around $1 billion in sales.
Roche will hope that by extending its brain cancer licence for the drug, this will help offset the loss of its breast cancer licence, alongside its new European indication for ovarian cancer.
AVAglio Study
GBM is the most common and aggressive type of glioma – cancer of the glial cells, which in turn accounts for one-third of all malignant brain tumours – and it affects around 13,000 people a year in Europe.
AVAglio assessed the efficacy and safety of the combination following surgery or biopsy in patients with newly diagnosed GBM.
One patient arm received Avastin plus radiation and temozolomide for six weeks followed by a four-week break, then Avastin and temozolomide for up to six cycles, then Avastin alone until disease progression.
The other had radiation, temozolomide and placebo for six weeks followed by a four-week break, then received temozolomide and placebo for up to six cycles, followed by placebo until disease progression.
Secondary endpoints included one- and two-year survival rates, PFS as assessed by an independent review committee, safety profile and quality of life measures.
Other manufacturers are also interested in the brain cancer market: Actelion’s dual endothelin receptor antagonist Macitentan is being investigated in in patients with recurring GBM.
And Merck KgaA’s Phase III CENTRIC study is assessing investigational drug cilengitide radiotherapy plus temozolomide again as a first-line treatment for GBM.
Adam Hill
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