Merck plans cancer drug submissions later this year
pharmafile | June 7, 2011 | News story | Research and Development, Sales and Marketing | Merck & Co, ridaforolimus
Merck & Co is to submit its oral investigational cancer drug ridaforolimus to European and US regulators later this year following encouraging phase III results.
The marketing application in the European Union and New Drug Application to the Food and Drug Administration will be based on the SUCCEED trial – for which the FDA granted ridaforolimus a Special Protocol Assessment.
The mTOR inhibitor improved progression-free survival (PFS) compared to placebo in patients with metastatic soft-tissue or bone sarcomas, who had previously responded well to chemotherapy.
If brought to market, it would compete with Novartis’ own oral mTOR inhibitor Afinitor, approved by the FDA last year, which currently has a licence as a second-line treatment for advanced renal cell carcinoma.
The SUCCEED results were presented during the 2011 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Patients took oral ridaforolimus 40 mg five days out of seven each week, and 552 out of 711 patients experienced PFS, with a 28% reduction in the risk of progression or death compared to placebo.
Median PFS was 17.7 weeks for those treated with ridaforolimus compared to 14.6 weeks in the placebo group.
An investigator assessment analysis of PFS showed a 31% reduction by ridaforolimus in the risk of progression or death compared to placebo, with median PFS rising to 22.4 weeks versus 14.7 weeks.
The independent radiological committee review analysis showed that the proportion of patients with PFS in the ridaforolimus group versus placebo was 70% versus 54% after three months and 34% versus 23% after six months.
“These data bring us one step closer to making ridaforolimus available to patients with metastatic sarcoma who need it,” said Eric Rubin, vice president of clinical oncology research at Merck.
“Patients with metastatic soft-tissue and bone sarcomas have limited treatment options available to them,” added Sant Chawla, director of Santa Monica’s Sarcoma Oncology Center, who presented the results at ASCO.
“Data from the SUCCEED trial show that ridaforolimus maintained the benefit of prior conventional chemotherapy,” Chawla continued. “The study met the primary endpoint of PFS, showing a clinically meaningful and statistically significant improvement.”
Secondary endpoints included trends in overall survival (with data so far favouring ridaforolimus) and best target lesion response (average lesion size reduction of 1.3% versus average increase of 10.3% with placebo).
There is also to be an assessment of cancer-related symptoms, although no conclusions have been made yet.
The most common severe adverse events were thrombocytopenia, stomatitis, anemia and hyperglycemia, and there were six deaths from pulmonary disorders in the ridaforolimus group against none in the placebo group.
Merck acquired the exclusive license for ridaforolimus a year ago from oncology specialist Ariad Pharmaceuticals, which discovered it.
Merck had previously worked with Ariad on a co-development and co-commercialisation basis. The drug is being investigated in a number of different forms of the disease, including non-small cell lung cancer.
Adam Hill
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