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Clinical Safety Data Review of Study NCIC CTG PA.3

Clinical Safety Data Review of Study NCIC CTG PA.3. Karsten Witt, MD Vice President Drug Safety and Medical Writing OSI Pharmaceuticals, Inc. Overall Tarceva Safety Experience. >18,000 patients † have been treated No new safety signals

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Clinical Safety Data Review of Study NCIC CTG PA.3

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  1. Clinical Safety Data Review of Study NCIC CTG PA.3 Karsten Witt, MD Vice PresidentDrug Safety and Medical Writing OSI Pharmaceuticals, Inc.

  2. Overall Tarceva Safety Experience • >18,000 patients† have been treated • No new safety signals • Approximately 6,300 subjects‡ participated in company-sponsored clinical trials: • 562 pancreatic cancer patients (PA.3) † From November 2004 to July 2005 ‡ As of February 2005

  3. Tarceva/Placebo Exposure 100 mg Cohort • Patients received the intended dose intensity of Tarceva

  4. Gemcitabine Exposure 100 mg Cohort • Tarceva did not compromise the dose intensity of concomitant gemcitabine

  5. Discontinuation Due To Protocol Therapy-Associated Toxicity 100 mg Cohort Note: Patients may discontinue due to more than one event

  6. Selected Adverse Events100 mg Cohort

  7. Grade 3 or 4 Adverse EventsOccurring in ≥ 5% of Patients—100 mg Cohort

  8. Serious Adverse EventsDefinition A serious adverse event is any event resulting in • Hospitalization or prolonged hospitalization† • Death • Life-threatening experience • Persistent or significant disability/incapacity • Congenital anomaly/birth defect • Important medical event † Excluding for palliative care and pain control, chemotherapy administration,routine procedures, investigations

  9. Serious Adverse EventsOccurring in ≥ 2% of Patients—100 mg Cohort

  10. ILD-Like Cases Reported as SAEs100 and 150 mg Cohorts

  11. Deaths Attributed to Protocol Treatment • Five deaths were attributed to protocol treatment in the 100 mg cohort (all in Tarceva + gemcitabine arm)

  12. Laboratory Abnormalities Maximum Grade per Patient on Study—100 mg Cohort

  13. Safety Summary • Treatment with Tarceva 100 mg/day in combination with gemcitabine was tolerated by most patients • Rash and diarrhea were reported more often in the Tarceva arm • ILD-like serious adverse events were infrequent • Hematologic toxicity of gemcitabine was not increased by the addition of Tarceva

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