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Investor Update

Basel, August 1, 2009

Phase III study showed Tarceva helped patients with advanced non-small cell lung cancer live longer when used immediately after initial chemotherapy

Roche today announced that patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva® (erlotinib) immediately after initial chemotherapy in SATURN, a pivotal Phase III study, had a significant, 23% improvement in overall survival (hazard ratio =0.81; p-value=0.0088) compared to patients who received placebo. As previously announced, the safety results in this study were consistent with what has been seen before and there were no new or unexpected safety signals. Overall survival was a key secondary endpoint of the study and these new survival data were presented during the ongoing 13th World Conference on Lung Cancer being held in San Francisco.1

The SATURN study has now shown that treatment with Tarceva immediately after initial chemotherapy significantly delayed cancer growth or spread and helped extend patients’ lives.

Jean-Jacques Garaud, Head of Global Pharma Development at Roche said, “These data confirm the benefit of immediate use of Tarceva after initial chemotherapy. We hope that based on our regulatory submission Tarceva will become the first oral option approved in this setting to help people with advanced lung cancer live longer.”

Importantly, the study demonstrated that patients whose tumors did not have genetic mutations of the epidermal growth factor receptor (EGFR 'wild type') who received Tarceva experienced a significant 30% improvement in survival, compared to placebo. The vast majority of patients with NSCLC (nearly 90%) are EGFR wild-type. The median survival has not yet reached statistical significance in patients whose cancer had EGFR mutations.

Professor Federico Cappuzzo, M.D., Istituto Clinico Humanitas IRCCS, Milan and principal investigator of the SATURN study said, “Currently many patients with advanced lung cancer are unable to receive second-line therapy after their initial chemotherapy because the cancer advances rapidly and their health declines. These new survival data give a compelling reason to use Tarceva earlier, after initial chemotherapy.”  

Roche and OSI, its US collaborator for Tarceva, will use the overall survival data to support their European and US applications for Tarceva in first-line maintenance use for patients with advanced NSCLC. These applications were made to the European Medicines Agency (EMEA) and US Food and Drug Administration (FDA) in March 2009 and are based on the pivotal phase III SATURN trial.  

Lung cancer is the most common cancer worldwide with 1.5 million new cases annually2 and NSCLC accounts for almost 85 % of all lung cancers3. NSCLC progresses rapidly; less than 5% of advanced NSCLC patients survive for five years3. Extending the time patients live and managing side effects are key treatment goals.

Tarceva is already a well established treatment in second-line management of advanced NSCLC after the failure of chemotherapy and is proven to extend survival for a broad range of patients in this setting.4

SATURN – key results summary

A global multicentre, double blind, randomised, prospective phase III study to evaluate the efficacy of Tarceva or placebo in patients with advanced, recurrent or metastatic NSCLC who had not progressed following first-line platinum-based chemotherapy. The study involved more than 880 patients from approximately 160 centres; 438 received Tarceva and 451 placebo.

  • The study met its primary endpoint demonstrating a statistically significant extension of the time patients live without their disease worsening; there was a 41% increase compared with placebo (hazard ratio= 0.71; p-value <0.0001).
  • Overall survival was a secondary endpoint in the study. There was a 23% improvement in overall survival compared to patients who received placebo (hazard ratio =0.81; p-value=0.0088).
  • A preplanned exploratory subgroup analysis showed that there was a 30% improvement in overall survival for patients identified as EGFR ‘wild type’ who received Tarceva (n=199) compared to patients identified as EGFR ‘wild type’ (n=189) who received placebo (hazard ratio =0.77; p-value=0.0243). Overall survival is still immature with the median survival not yet reaching statistical significance in patients with EGFR mutations receiving Tarceva.  Determination of the overall survival benefit in this sub-group was further confounded by the fact that two thirds of the patients with EGFR mutations who received placebo crossed over to receive Tarceva or another EGFR therapy. An ongoing Phase III trial evaluating how Tarceva compared to traditional chemotherapy for first-line treatment in patients whose tumours had an EGFR mutation is expected to provide more insight. This study, called EURTAC, is a collaboration between Roche and the Spanish Lung Cancer Group.

About Tarceva

Tarceva is different from conventional chemotherapies and has been shown to potently inhibit EGFR. It is the first and only EGFR oral targeted agent in second-line with a proven and significant survival and symptom benefit in a broad range of patients with advanced lung cancer without the side effects associated with chemotherapy. Tarceva has been approved in the EU since September 2005 and in the US since November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Furthermore, Tarceva in combination with chemotherapy is the first treatment in over a decade to have shown a significant survival benefit in treating patients with pancreatic cancer. It is approved in the US in combination with gemcitabine for the first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer and in the EU for treatment of metastatic pancreatic cancer. Since its launch Tarceva has been used to treat some 400,000 patients and is now approved in 95 countries worldwide.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.

In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
1) Cappuzzo F et al. Presented at 13th World Congress on Lung Cancer, San Francisco, US.
2) Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American Cancer Society, 2007.
3) Allen J et al. J Natl Compr Canc Netw 2008; 6(3): 285-93.
4) Shepherd FA et al. N Engl J Med 2005; 353:123-132.