Investor Update

Basel, 29 April 2010

Tarceva now approved in the EU for maintenance use in advanced lung cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Tarceva (erlotinib) as monotherapy for maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose disease remains largely unchanged (known as ‘stable disease’) after platinum-based initial chemotherapy. The approval is based on data from the pivotal SATURN study which showed that compared to placebo Tarceva gave patients with stable disease a 39% improvement in overall survival (OS) and a 2.3 month improvement in median survival (11.9 months vs. 9.6 months1.)  

Patients with advanced NSCLC whose tumours remain largely unchanged after initial chemotherapy (‘stable disease’) have tumours that progress faster, are more resistant to further lines of chemotherapy and have a poorer prognosis compared to patients with a complete or partial response to initial chemotherapy.2 When entering the pivotal SATURN study approximately half of patients randomised after initial chemotherapy had stable disease.

“The approval of Tarceva for maintenance use in stable, advanced non-small cell lung cancer offers patients a much needed additional treatment option and reinforces the role that this medicine has to play in treating this devastating disease,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. “Instead of waiting for their disease to progress, patients can now opt to continue to keep it under control, which may help them live longer.”

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. Tarceva also recently gained approval from the U.S. Food and Drug Administration (FDA) for maintenance treatment of NSCLC (see below).

About SATURN

  • Patients with stable disease had pronounced progression free survival (PFS) and OS benefits when Tarceva maintenance therapy was given. In the stable disease intent to treat population the hazard ratio for PFS was 0.68 (95% CI 0.56-0.83) showing a statistically significant benefit for the Tarceva group (p<0.0001). This corresponds to a 47% improvement in PFS. In the stable disease intent to treat population, the hazard ratio for OS was 0.72 (95% CI: 0.59-0.89; p=0.0019). This statistically significant survival benefit represents a 39% improvement in OS with Tarceva for patients with stable disease1.
  • Stable disease is confirmed when there is neither sufficient shrinkage of the cancer to qualify as a partial response (a least 30% decrease) nor sufficient increase to qualify for disease progression (at least 20% increase).
  • Adverse events in SATURN study were consistent with previous Tarceva studies and no new safety signals were observed.   

About Tarceva

Tarceva, an oral treatment, is different from conventional chemotherapies. It has been shown to potently inhibit epidermal growth factor receptor (EGFR), a protein involved in the growth and development of cancers. Tarceva is the first and only EGFR inhibitor to be approved for maintenance treatment in people with advanced or metastatic NSCLC and stable disease. It is also the first EGFR inhibitor to be approved for use in second-line treatment for advanced NSCLC. In both maintenance and second-line settings Tarceva has a proven and significant survival and symptom benefit without the side effects profile associated with chemotherapy.

In addition, 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 initial launch Tarceva has been used to treat more than 400,000 patients worldwide and is now approved in more than 100 countries worldwide.

US label – NSCLC maintenance treatment

On April 16, 2010 the U.S. Food and Drug Administration (FDA) approved Tarceva as a maintenance treatment for patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

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 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 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

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References
1 Tarceva Summary of Product Characteristics (SmPC) 2010
2 Disease control rate at 8 weeks predicts clinical benefit in advanced non-small cell lung cancer: results from Southwest Oncology Group randomised trials. Lara PN et al. J Clin Oncol (2008). 26:3, 463 – 467