Genentech’s Phase III lung cancer trial meets endpoint

The Phase III Atlas study was stopped early on the recommendation of an independent data safety monitoring board after a pre-planned interim analysis showed that combining Tarceva and Avastin significantly extended the time patients lived without their disease advancing, as defined by progression-free survival (PFS), compared to Avastin plus placebo.

A preliminary safety analysis showed adverse events were consistent with previous Avastin or Tarceva studies, as well as trials evaluating the two medicines together, and no new safety signals were observed.

Atlas is a global, multicenter, randomized, double-blind, placebo-controlled study that enrolled 1,157 patients with locally advanced, recurrent or metastatic non-small cell lung cancer. In order to evaluate patients who are often excluded from Avastin-based clinical trials, patients with treated brain metastases, tumors of squamous cell histology that were not centrally located in the lung, and those taking blood-thinning medications were eligible for this trial.

The study’s primary endpoint of PFS, as determined by investigators, was defined as the length of time from randomization to disease progression or death from any cause. PFS assessment began from the start of the maintenance phase of the study after initial treatment with four cycles of Avastin and chemotherapy. Secondary endpoints included overall survival, incidence of all adverse events and selected grade 3 or greater adverse events and incidence of treatment discontinuation for reasons other than disease progression.

Hal Barron, chief medical officer of Genentech, said: This is the second study to show that people with lung cancer who took the daily pill Tarceva following initial treatment lived longer without their cancer getting worse. We plan to discuss these data with the FDA to determine next steps.