Lilly's Gemcitabine; First Phase III Results

28 November 1994

Recently-compiled and so-far unpresented data from a Phase III trial comparing Eli Lilly's gemcitabine with 5-fluorouracil therapy in pancreatic cancer patients were revealed to the Marketletter at the 19th congress of the European Society of Medical Oncology in Lisbon, Portugal, last week.

A senior clinical researcher at Lilly said that the US and Canadian trial, results of which will be presented at the next American Society of Clinical Oncology meeting, showed that gemcitabine was significantly superior to 5-FU in this notoriously difficult-to-treat cancer. 120 patients took part in the study, but due to the severity and poor prognosis with the disease it had taken the company two and a half years to complete enrollment. A particularly onerous requirement was that patients had to show stable pain management at the time of entry, he said.

The measurement of response rates in the trial addressed two parameters, with not only tumor response but also organ degeneration (a major characteristic of pancreatic cancer), being used as endpoints. Overall response rates in the study were 28% in the gemcitabine group and 4% in the 5-FU group (the usual 5-FU response rate is 0%-10%). The median response time was was 5.7 months in the gemcitabine arm and four months in the 5-FU arm. Further details of the trial were not divulged.

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