AstraZeneca plans to meet with FDA and clinical investigators to discuss the progress of a lung cancer survival study of Iressa (gefitinib) once it sees the "details" of a study showing improved survival in patients treated with Genentech/OSI's Tarceva (erlotinib).

AstraZeneca is "planning a meeting with principal investigators and the FDA when more details of the Tarceva study will be available," the company told investors during an April 29 conference call.

Genentech and OSI announced April 26 that a placebo-controlled Phase III study (protocol BR 21) of Tarceva found a survival benefit in patients with relapsed non-small cell lung cancer (see ¹ Also see "Tarceva Survival Benefit Differentiates Oncologic From Iressa – Genentech" - Pink Sheet, 3 May, 2004.).

AstraZeneca is conducting a survival study of Iressa modeled on BR 21 as a post-marketing commitment (² Also see "Iressa Clears FDA: Phase IV Symptom Trial Will Be First Shot At Full Approval" - Pink Sheet, 12 May, 2003., p. 3). Iressa received accelerated approval in May 2003; Genentech and OSI are in the process of filing a rolling NDA for Tarceva.

The Iressa study results are due in October 2005. However, AstraZeneca said, "we are increasingly confident that we will be able to determine the survival benefit of Iressa ahead of our originally announced timetable of the second half of 2005."

The company has enrolled over 1,000 patients in the study - 50% more than the BR 21 trial, AstraZeneca noted.

"Be in no doubt," AstraZeneca CFO Jonathan Symonds declared, "we are very encouraged by the Tarceva study result." Based on "the limited data we have available to us, the results would appear to be consistent with our experience with Iressa."

"It is good news to the patients and to the class," Symonds said. "We - like you - are looking forward to hearing more details" when the data are presented during the American Society of Clinical Oncology meeting in June.

AstraZeneca reported worldwide Iressa sales of $93 mil. in the first quarter, including $51 mil. in the U.S. Prescriptions for Iressa totaled 22,000 during the quarter, an 8% increase from the fourth quarter level.

Iressa Survival Study Is Ahead Of Schedule, AstraZeneca Says

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