Data from the Phase III ATLAS Study Show Tarceva in Combination with Avastin as First-Line Maintenance Therapy Improved Progr...

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that its U.S. partner for Tarceva® (erlotinib), Genentech, Inc., a wholly-owned member of the Roche Group, informed OSI of detailed results from a Genentech conducted Phase III study (ATLAS). The study met its primary endpoint by demonstrating that patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva in combination with Avastin® (bevacizumab) as first-line maintenance treatment had a 39 percent improvement in the time they lived without the disease worsening (progression-free survival or PFS), compared with those who received Avastin plus placebo as an active control (hazard ratio=0.72; p=0.0012; a hazard ratio of less than one indicates a decreased risk of disease progression and a p-value of less than 0.05 indicates statistical significance). Adverse events were consistent with previous Avastin or Tarceva NSCLC studies, or trials evaluating the two medicines together.

Genentech also informed OSI that median PFS following four initial cycles of Avastin and chemotherapy was 4.8 months for patients who received the combination and 3.7 months for those who received Avastin plus placebo. Overall survival data are expected in the second half of 2009. In February 2009, it was announced that ATLAS 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 PFS, compared with Avastin plus placebo.

Results of the ATLAS study were featured today during a press briefing at the 45th annual meeting of the American Society of Clinical Oncology (ASCO). Full results will be presented tomorrow by Dr. Vincent Miller (Abstract #LBA8002 – Sunday, May 31, 2009, 9:30 a.m. – 9:45 a.m. EDT, West Hall E1).

Full results of the SATURN study, which showed that patients who received Tarceva alone as a maintenance treatment following initial chemotherapy had a statistically significant 41% improvement in PFS compared with placebo (hazard ratio=0.71, p-value