Adam, We had a couple of companies -- OncoGenex Pharmaceuticals (OGXI) and Merrimack Pharmaceuticals (MACK) -- announced results from phase III studies of cancer drugs last week. Howd these results gibe with the predictions forecast by the Feuerstein-Ratain Rule?
The F-R Rule accurately called the failure of OncoGenexs custirsen prostate cancer study. The OncoGenex market cap on Dec. 28 (four months before custirsen results were announced) was $120 million. A market cap under $300 million forecasts phase III study failure.
And what about Merrimack? Its phase III study of MM-398 in second-line pancreatic cancer was positive.
That's correct, but Merrimack's relevant market cap (for F-R Rule prediction purposes) was $545 million. For companies with market caps between $300 million and $1 billion, the oncology phase III success rate is 59%. Investor expectations for MM-398 were definitely low, so the positive results are somewhat of an upside surprise. However, the F-R Rule did not rule out success like it did with OncoGenex.
Weren't you supposed to update the Feuerstein-Ratain Rule with some new data?
Yes! I presented the updated Feuerstein-Ratain Rule at the American Association for Cancer Research (AACR) annual meeting in April. The big headline: The F-R Rule is still 100% accurate predicting failure for oncology phase III studies undertaken by companies with market caps less than $300 million.
Sure. When Dr. Mark Ratain and I came up with the concept for the F-R Rule in 2011, we were limited to analyzing a data set of 59 phase III oncology clinical trials conducted between 2000 and 2009.