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Investor Update

Basel, 17 November 2009

Applications to allow Avastin to be combined with commonly used chemotherapies in advanced breast cancer submitted to FDA

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Genentech, a wholly-owned member of the Roche Group, has submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment).  One sBLA is based on the phase III AVADO study that investigated Avastin in combination with docetaxel chemotherapy.  The other is based on the phase III RIBBON-1 study that investigated Avastin in combination with a taxane or anthracycline-based chemotherapy or the oral chemotherapy, Xeloda (capecitabine).  Both studies met their primary endpoints of improving the time women lived without the disease worsening (progression-free survival or PFS).

In the US, Avastin is currently FDA-approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer.  This approval was based on results of the phase III E2100 study and granted under the FDA’s accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases.  Data from AVADO and RIBBON-1 have been submitted as part of Genentech’s effort to convert the accelerated approval to a full approval.  

In the EU, Avastin is currently licensed as first-line treatment of patients with metastatic breast cancer in combination with paclitaxel or docetaxel based on the E2100 and AVADO studies.

AVADO and RIBBON-1 demonstrated that Avastin plus commonly used chemotherapies (taxane-based chemotherapy, anthracycline-based chemotherapy and capecitabine) increased the time women lived without the disease growing or spreading, compared to the chemotherapies alone.  In these studies, adverse events were consistent with those previously reported for Avastin and no new Avastin safety signals were observed.

Each year more than one million women are diagnosed with breast cancer worldwide, and over 400,000 of these women die from their disease.1

Genentech is committed to understanding the potential role of Avastin in breast cancer and will separately submit to the FDA data from three other randomized Phase III studies of Avastin in this disease when available, including the recently announced RIBBON 2 study in patients who have previously received chemotherapy for metastatic HER2-negative breast cancer.

About AVADO (BO17708)

AVADO is an international phase III trial where 736 patients who did not receive previous chemotherapy for their HER2-negative metastatic breast cancer were randomised to one of three treatment groups:

  • Avastin 15 mg/kg every 3 weeks in combination with docetaxel 100 mg/m2
  • Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel 100 mg/m2
  • Placebo in combination with docetaxel 100 mg/m2  as control arm

The primary objective of the study was to demonstrate superiority in progression free survival in one or both of Avastin containing treatment arms compared to the control arm. The study demonstrated an up to 49% increase in the patient’s chance of being alive without their disease progressing (‘progression free survival’) when treated with Avastin plus docetaxel compared to docetaxel alone (Hazard ratio of 0.67 and p=0.0002; updated PFS Analysis). Secondary endpoints for the study included response rate, duration of response, time to treatment failure, overall survival, 1-year survival, quality of life, safety and tolerability.

About RIBBON-1

RIBBON-1 is a global, double-blind, randomised phase III trial with 1,237 patients who did not receive previous chemotherapy for their HER2-negative metastatic breast cancer.  RIBBON-1 comprised two independently-powered treatment cohorts that evaluated Avastin with different types of chemotherapies in people with advanced HER2-negative breast cancer:  

  • Cohort One: Avastin or placebo plus a taxane (protein-bound paclitaxel or docetaxel) or anthracycline-based chemotherapies (doxorubicin- or epirubicin-based regimens)  
  • Cohort Two: Avastin or placebo plus Xeloda

Standard anthracyline-based regimens included the following:

  • FEC (Fluorouracil (5FU), epirubicin and cyclophosphamide),
  • EC (epirubicin and cyclophosphamide),
  • AC (doxorubicin and cyclophosphamide),
  • FAC (Fluorouracil (5FU), doxorubicin and cyclophosphamide)

The primary objective of RIBBON-1 was to demonstrate superiority in progression-free survival of Avastin containing treatment arms compared to the control arms. Avastin yielded superior progression-free survival in both treatment groups.  

Patients receiving Avastin plus taxane or anthracycline-based chemotherapies had a 55 percent increase in the chance of being alive without disease progression compared to those who received the chemotherapies alone (hazard ratio=0.64; p<0.0001).  Patients receiving Avastin plus Xeloda had a 45 percent increase in the chance of being alive without disease progression compared to those who received the chemotherapy alone (hazard ratio=0.69; p=0.0002).

Secondary endpoints for the study included response rate, duration of response, overall survival, PFS by independent review, safety and tolerability.

About Avastin

Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is a key driver of tumour angiogenesis – an essential process required for a tumour to grow and to spread (metastasize) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumour growth and extend survival with only a limited impact on the side effects of chemotherapy.

Avastin has proven survival benefits across several types of cancer. It is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. These types of cancer collectively cause over 2.5 million deaths each year1,2,3. In the US, Avastin was the first anti-angiogenesis therapy approved by the FDA and it is now approved for the treatment of five tumour types: colorectal cancer, non-small cell lung cancer, breast cancer, brain (glioblastoma) and kidney cancer (renal cell carcinoma).

Over half a million patients have been treated with Avastin so far. A comprehensive clinical programme with over 450 clinical trials is investigating the use of Avastin in various tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian, prostate and others) and different settings (advanced or early stage disease).

About Xeloda (capecitabine)

Xeloda is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs. Xeloda is converted to the active cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells, thus reducing damage to healthy cells. Xeloda tablets can be taken by patients in their own home, reducing the number of hospital visits.

Licensed and marketed by Roche in more than 100 countries worldwide, Xeloda has more than ten years of proven clinical experience providing an effective and flexible treatment option to over 1.8 million people with cancer.

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.Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American Cancer Society, 2007
2.WHO Cancer Factsheet N°297 – updated July 2008. Last accessed 24 March 2009 at http://www.who.int/mediacentre/factsheets/fs297/en/index.html.
3.Parkin DM et al. CA Cancer J Clin 2005; 55: 74-108.