Investor Update

Basel, 21 May 2010

Roche to Present New Data on Different Approaches To Treating Cancer at ASCO

New Results for Avastin in Ovarian Cancer and MabThera in Lymphoma

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it will present new data for its targeted cancer medicines and the way they may be used in several different cancer types at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Approximately 400 abstracts featuring Roche’s cancer medicines and investigational agents across 30 cancer types will be presented during the meeting that is taking place June 4 to 8, 2010 in Chicago.

Key study results to be presented at the meeting include:

  • Avastin (bevacizumab): Late-breaking Phase III data (GOG 0218) with positive results in advanced ovarian cancer where new therapies are urgently needed, as well as new data on the use of Avastin in multiple lines of therapy in advanced colorectal cancer.
  • MabThera (rituximab): Phase III data (PRIMA) on maintenance use of MabThera in follicular lymphoma, an incurable cancer where people experience periods of relapse and remission as the disease progresses (see separate press release issued today).
  • Novel combination of HER2-targeted medicines: Phase Ib/II preliminary efficacy, safety and tolerability data for the HER2 antibody-drug conjugate, trastuzumab-DM1 (T-DM1), in combination with pertuzumab, a HER dimerization inhibitor, in previously treated women with advanced HER2-positive breast cancer.

“Our targeted medicines have helped millions of people with cancer and we continue to learn more about who may benefit the most and how best to use our medicines,” said Pascal Soriot, Chief Operating Officer of Roche’s Pharmaceuticals Division. “We're also excited to share data on the medicines in our pipeline that we hope will give people new options for fighting this devastating disease.”

The Roche worldwide oncology pipeline includes 22 new investigational medicines, five of which are in late-stage development.

Avastin in Various Cancer Types

Phase III Trial of Bevacizumab in the Primary Treatment of Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer: A Gynecologic Oncology Group (GOG) Study (Abstract #LBA1) – Sunday 6 June 2010, 13:45 – 14:00 CDT, North Hall B1. Data will also be highlighted in an ASCO press briefing at 08:00 CDT on Sunday 6 June

Positive results from the first Phase III trial (GOG 0218) of Avastin in ovarian cancer are under ASCO embargo and will be presented during the plenary session at the meeting. The trial met its primary endpoint and showed the combination of Avastin plus carboplatin and paclitaxel chemotherapy followed by maintenance use of Avastin alone increased the time women with previously untreated advanced ovarian cancer lived without the disease worsening (progression-free survival or PFS), compared to carboplatin and paclitaxel chemotherapy alone.

GOG 0218 is the first Phase III study of an anti-angiogenic medicine in advanced ovarian cancer to meet its primary endpoint. The results highlight the importance of continuing with Avastin after combining Avastin with chemotherapy in this setting.

Clinical Outcomes in Bevacizumab-Treated Patients With Metastatic Colorectal Cancer: Results from ARIES Observational Cohort Study and Confirmation of BRiTE Data on Bevacizumab Beyond Progression (Abstract #3596) – Sunday 6 June 2010, 14:00 – 18:00 CDT, South Hall A2

An analysis from the ongoing non-randomized Phase IV ARIES observational study evaluated survival in more than 1,000 people with advanced colorectal cancer who initially received Avastin in combination with chemotherapy and then, following growth or spread of the cancer, continued with an Avastin-based regimen. The results suggested that people who continued an Avastin-based regimen after the cancer progressed lived longer than people who switched to a non-Avastin containing regimen or stopped treatment altogether.

In this analysis, people who continued an Avastin-based regimen after the cancer worsened had a 59 percent decrease in the risk of death compared to those who switched to a non-Avastin containing regimen or stopped therapy altogether (based on a hazard ratio of 0.41, p<0.001). Median survival after the first disease progression was:

  • 16.3 months for patients who continued an Avastin-based regimen
  • 8.5 months for those who received a non-Avastin containing regimen
  • 5.2 months for those who stopped therapy altogether

Updated efficacy and safety data, including results for PFS and overall survival, will be reported at the meeting.

A large, randomized Phase III trial is evaluating the continued use of an Avastin-based regimen, compared to chemotherapy alone, in second-line after progression following first-line use of Avastin plus chemotherapy. This trial will soon complete enrollment. Avastin is not currently approved for this use.

Advances in Combining HER2-Targeted Medicines

A Phase Ib/II Trial of Trastuzumab-DM1 (T-DM1) With Pertuzumab for Women With HER2-Positive Locally-Advanced or Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab (Abstract #1012) – Saturday 5 June 2010, 08:00 – 12:00 CDT, E450b; 12:00 – 13:00 CDT, East Hall D1

This early-phase trial evaluated the combination of investigational medicines T-DM1 and pertuzumab in 67 women with advanced HER2-positive breast cancer. Preliminary results from 23 patients whose disease had worsened after receiving a median of eight prior treatments (range: 4-15), including Herceptin (trastuzumab) and lapatinib, showed the combination of these two investigational medicines shrank tumors in 9 of 23 women.

Safety results suggested the T-DM1 plus pertuzumab combination did not result in an increase in serious (Grade 3 or 4) adverse events compared to those previously reported for T-DM1 alone.

Updated safety and efficacy results from additional patients will be presented at the meeting.

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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