'Speak for yourself'
After seeing its Iressa epidermal growth factor receptor inhibitor fail in combination with chemotherapy, AstraZeneca plc suggested last week that the problem might be related to the entire class of EGFR compounds. But while the pharma company didn't offer any evidence to back up this notion, it clearly roiled the waters for its competitors, as investors slashed valuations of other competitors in the space as well as AZN.
While more data ultimately will determine whether AZN was simply too glib, outside experts questioned AZN's trial design while the other players in the space pointed to differences in their compounds that may allow them to succeed where Iressa failed.
AZN (London, U.K.) reported that Iressa gefitinib failed to add to the efficacy of platinum-based chemotherapy in its INTACT 1 and INTACT 2 Phase III trials in a total of more than 2,000 patients with advanced non-small cell lung cancer (NSCLC).
The INTACT results contrasted with results of IDEAL 1 and IDEAL 2, two Phase II studies of Iressa as monotherapy. In IDEAL 2, the best dose of Iressa gave a 12% response rate and a 6.5 month median survival rate in patients not responding to chemotherapy, with similar results from IDEAL 1 (see "The Devil is in the Details," A7).
AZN said the INTACT studies were well-designed and well-conducted and said it would drop development of Iressa in combination with chemotherapy. The pharma company went on to suggest that