Genentech/OSI's anti-EGFR agent Tarceva is associated with a two-month improvement in survival for non-small cell lung cancer patients who have failed standard therapy, according to pivotal trial data presented at the American Society of Clinical Oncology annual meeting in New Orleans June 7.

A rolling NDA filing started Jan. 21; the remaining data are expected to be submitted this summer. The application for full approval will be based on Phase III survival data on the effect of erlotinib in refractory non-small cell lung cancer.

Genentech and OSI announced April 26 that a placebo-controlled Phase III study (protocol BR21) of Tarceva found a survival benefit in patients with relapsed non-small cell lung cancer (¹ Also see "Tarceva Monotherapy Shows Survival Benefit, Differentiates Oncologic From Iressa – Genentech" - Pink Sheet, 26 April, 2004.).

The placebo-controlled trial enrolled 731 patients, with 50% having received one prior regimen and the remainder having received two prior regimens.

Patients receiving Tarceva had a median survival rate of 6.7 months compared to 4.7 months for placebo patients (p=.001). After one-year, 31% of Tarceva patients were alive compared to 22% of patients on placebo.

The objective response rate for Tarceva was 9%, compared to less than 1% for placebo; duration of response for Tarceva and placebo patients was 7.9 months and 3.1 months, respectively.

The most common toxicity seen was rash. However, the investigators noted both placebo and Tarceva patients developing rash appeared to improve more than those who did not. Less than 2% of Tarceva deaths were deemed to be a result of treatment, compared to 1% in the placebo arm.

If approved, Tarceva would be the second oral anti-EGFR agent to enter the class, following AstraZeneca's Iressa (gefinitib).

In the Tarceva study, approximately half of the patients enrolled had adenocarcinoma. Investigators said there were not any statistically significant differences in the effect seen in Japanese and Caucasian patients.

Last year, Tarceva failed to show a survival benefit in two combination therapy studies (TALENT and TRIBUTE).

- Kara Kasper, Adam Eckstein

Genentech/OSI Tarceva Shows Two-Month Improvement Over Placebo

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