Amgen scraps pancreatic cancer drug
pharmafile | August 9, 2012 | News story | Research and Development, Sales and Marketing | Amgen, GAMMA, Ganitumab, pancreatic
Biotech company Amgen has abandoned its late-stage trial of a new drug for one of the most hard-to-treat of all cancers.
Ganitumab (AMG 479), a fully human monoclonal antibody that targets type I insulin-like growth factor receptor (IGF1R), was in a Phase III study for patients with metastatic pancreatic cancer.
The California-based company stopped it after deciding that a positive outcome was unlikely and will also cease treatment in a separate ongoing Phase II trial in locally advanced forms of the disease.
It is a blow for sufferers: a report from the Macmillan cancer charity last year showed that pancreatic cancer continues to have one of the worst mortality rates, with median survival – the time it takes until half of those diagnosed have died – of less than six months.
There are currently no targeted cancer medicines available, with chemotherapy drugs – such as Lilly’s out-of-patent Gemzar (gemcitabine) or Roche’s Xeloda (capecitabine) – currently the only option for advanced forms of the disease.
Amgen’s GAMMA study added ganitumab to Gemzar, but an independent data monitoring committee decided it was unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to Gemzar alone.
“These disappointing results underscore the difficulty of treating pancreatic cancer, which remains a major unmet medical need,” admitted Sean Harper, executive vice president of R&D at Amgen.
There has been a major improvement for most cancers over the past 40 years, with half a dozen forms now having survival times of more than ten years – but pancreatic cancer is still stubbornly tough to control.
The main problem is that only around one in ten patients is diagnosed in time for surgery, currently the only potential for a cure.
Despite being the fifth biggest cancer killer in the UK, the disease is underfunded, say charities: Pancreatic Cancer Action believes it currently receives just 1% of total cancer research funding.
The failure of ganitumab in this randomised, multi-centre, double-blind trial means that metastatic adenocarcinoma of the pancreas will remain a virtual death sentence.
The decision to stop GAMMA was based purely on the review of a pre-planned interim analysis, says Amgen. No safety concerns were raised.
The firm said it has spoken to regulators and is ‘in the process’ of notifying study investigators that treatment with ganitumab should be ceased.
Adam Hill
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