Bayer cancer drug meets Phase III goal
pharmafile | April 3, 2012 | News story | Research and Development, Sales and Marketing | Bayer, Cancer, Glivec, Novartis, phase III, regorafenib
Bayer’s stomach cancer pill regorafenib has significantly improved progression free survival in late-stage patients.
Results from the Phase III trial GRID study showed that regorafenib significantly improved progression-free survival in patients with metastatic and/or unresectable gastrointestinal stromal tumours (GIST).
It was being tested in patients whose disease has progressed despite prior treatment with Novartis’ Glivec (imatinib) and Pfizer’s Sutent (sunitinib), which are both licensed to treat GIST.
Bayer said it now plans to submit regorafenib for marketing authorisation in the treatment of metastatic and/or unresectable GIST, based on the new data.
Bayer, which is co-developing the drug with Onyx, said more detailed data from the study would be presented at an upcoming scientific meeting.
Regorafenib had also shown positive results in a Phase III trial for the treatment of patients with metastatic colorectal cancer, whose disease has progressed after approved standard therapies.
Bayer plans to submit regorafenib for a marketing authorisation in this type of cancer in the next two months.
The firms expect to make more than €2 billion ($2.8 billion) in peak annual sales from the treatment, if it receives licences for both GIST and colorectal cancers.
Regorafenib is an oral multi-kinase inhibitor targeting angiogenic, tumour microenvironment and oncogenic kinases.
It works by inhibiting several angiogenic VEGF receptor tyrosine kinases, which play a role in tumour neoangiogenesis and lymphangiogenesis.
GIST is the most common form of sarcoma (a type of cancer that develops from certain tissues, like bone or muscle) involving the gastrointestinal tract.
This type of cancer represents a potentially life-threatening disease if it has (metastasised), or is unable to be surgically removed.
In the US, it is estimated that there are around 4,500-6,000 new cases of GIST diagnosed each year.
Ben Adams
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