Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ASCO IN BRIEF

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

SATURN fails to find predictive biomarker for Tarceva: Roche/OSI's Phase III SATURN trial of Tarceva may help establish erlotinib as first-line maintenance therapy for non-small cell lung cancer patients who did not progress following first-line treatment with platinum-based chemotherapy, but it failed to establish KRAS mutation status as a predictive biomarker for Tarceva. The trial yielded a significant 41 percent improvement in progression-free survival, the primary endpoint, with a stronger PFS impact in patients with EGFR-positive tumors. But pre-planned biomarker analyses found benefit in both KRAS mutant and wild-type patients, though the effect was stronger in patients with KRAS mutations. "The EGFR immunohistochemistry, EGFR FISH and KRAS mutation status were not strong predictive factors, and selection of patients based on these is not warranted," Roche Clinical Science Leader, Tarceva Ivan Melezinak said. Overall survival data is expected to be ready in the second half of 2009. OSI submitted an sNDA to FDA based on the study in March, and Roche has filed for European approval. Results from the similar ATLAS study were also presented (1"The Pink Sheet" DAILY, Feb. 23, 2009); overall survival from that study, which supports the addition of Tarceva to Avastin after platinum chemo/Avastin therapy, are expected toward the end of the year

You may also be interested in...



Avastin Bid For Full Approval In Metastatic Breast Cancer May Require Another Trial

FDA says Roche/Genentech's follow-up studies did not produce clinically meaningful results using the progression-free survival endpoint.

Genentech Bid To Gain Full Approval For Avastin On Amassed PFS Data Gets July ODAC Hearing

Roche division also seeks approval for bevacizumab in new combinations based on AVADO and RIBBON-1 trial results, but the question remains whether the progression-free survival endpoint used in all the trials is sufficient for full approval.

Tarceva Advisory Committee To Focus On Treatment Alternatives, Subgroup Concerns

ODAC will review currently available treatment options and negative treatment effects in subgroups as OSI seeks to expand Tarceva's indication to first-line maintenance and monotherapy in NSCLC.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134025

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel