Roche Pharmaceuticals

New Study Suggests Combining Breakthrough Therapies Tarceva(R) and Avastin(R) May Provide More Hope for Lung Cancer Patients

    Basel, Switzerland (ots/PRNewswire) - A new study(1) suggests that treatment with the combination of the innovative cancer drugs Avastin (bevacizumab) and Tarceva (erlotinib) or Avastin with chemotherapy, improves progression-free survival in patients with recurrent or refractory non-small cell lung cancer (NSCLC), the most common form of lung cancer, when compared with standard chemotherapy alone. Progression-free survival is the time patients live without their cancer advancing. These data were presented today at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO), Atlanta.

    "These findings signal the potential for combining novel therapies that target different cancer growth pathways, to achieve better overall patient outcomes, with a low incidence of serious side effects," said Willem Verhoofstad, Global Business Director for Roche Oncology. "We are continuing to invest and explore the safety and efficacy of the Avastin and Tarceva combination and are currently conducting Phase III trials with both products in first-line and relapsed NSCLC settings."

    The randomised, Phase II exploratory study evaluated three treatment regimens in patients with recurrent or refractory NSCLC:

    - Avastin in addition to Tarceva

    - Avastin in addition to chemotherapy (either pemetrexed or docetaxel)

    - Chemotherapy alone (either pemetrexed or docetaxel) as control arm

    The study suggests that Avastin in combination with Tarceva or chemotherapy improves progression-free survival, the primary study endpoint, compared to chemotherapy alone. Median progression-free survival in the Avastin plus chemotherapy arm was 4.8 months, and was 4.4 months in the Avastin plus Tarceva arm, compared to just 3.0 months in the chemotherapy alone arm. The study results also showed that the toxicity profile of the Avastin plus Tarceva combination was favourable, resulting in fewer serious adverse events, when compared to either chemotherapy-containing arm. Due to the exploratory nature of this randomised Phase II study, these data do not provide definitive conclusions with respect to differences between the three treatment arms.

    About the Phase II Exploratory Study

    120 patients with recurrent or refractory NSCLC, who had not received previous treatment with Avastin or Tarceva, were enrolled into this study. Patients in the study had histologically or cytologically confirmed non-squamous NSCLC and had experienced clinical or radiographic disease progression during or following one platinum-based chemotherapy regimen for advanced stage disease (IIIb or IV).

    The key study results showed:

    - Treatment with Avastin plus Tarceva reduced the risk of cancer progression or death by 28 per cent compared to chemotherapy alone (based on a hazard ratio of 0.72).

    - Treatment with Avastin plus chemotherapy reduced the risk of cancer progression or death by 34 per cent compared to chemotherapy alone (based on a hazard ratio of 0.66),

    - Treatment with Avastin plus Tarceva saw 78% of patients alive at six months (median progression-free survival 4.4 months)

    - Treatment with Avastin plus chemotherapy saw 72% of patients alive at six months (median progression-free survival 4.8 months)

    - Treatment with chemotherapy alone saw 62% of patients alive at six months (median progression-free survival 3.0 months)

    - The toxicity profile of the Avastin plus Tarceva combination was favourable, resulting in fewer serious adverse events, when compared to either chemotherapy-containing arm

    - Adverse events in the Avastin plus Tarceva arm were similar to those observed in previous clinical trials of Avastin in combination with Tarceva, and included diarrhoea and rash

    - Adverse events in the Avastin plus chemotherapy arm were similar to those observed in previous clinical trials of Avastin in combination with chemotherapy, and included hypertension and bleeding

    About Tarceva

    Tarceva is an investigational small molecule that targets the human epidermal growth factor receptor (HER1) pathway. HER1, also known as EGFR, is a key component of this signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva blocks tumour cell growth by inhibiting the tyrosine kinase activity of the HER1 signalling pathway inside the cell.

    Taken as an oral, once-daily therapy, Tarceva is the only EGFR-inhibitor to have demonstrated a survival benefit in lung cancer. Currently most lung cancer patients are treated with chemotherapy which can be very debilitating due to its toxic nature. Tarceva works differently to chemotherapy by specifically targeting tumour cells, and avoids the typical side-effects of chemotherapy.

    Tarceva is approved in the US and across the European Union for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is approved in the US in combination with gemcitabine chemotherapy for the treatment of patients with locally advanced, inoperable or metastatic pancreatic cancer. A Marketing Authorisation Application was submitted to the European health authorities in November 2005.

    Tarceva is currently being evaluated in an extensive clinical development programme by a global alliance among OSI Pharmaceuticals, Genentech, and Roche, focussing on earlier stages of NSCLC. Additionally, Tarceva is being studied in combination with Avastin in NSCLC. Trials are also being conducted with Tarceva in other solid tumours, such as ovarian, bronchioloalveolar (BAC), colorectal, pancreatic, head and neck and glioma (brain).

    About Avastin

    Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supplies nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).

    Avastin is the first and only anti-angiogenic agent to have demonstrated improved overall and/or progression-free survival in the three major types of cancer leading to death: colorectal cancer, non-small cell lung cancer and breast cancer. In Europe, Avastin was approved in early 2005 for first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. Avastin received approval by the US Food and Drug Administration (FDA) in February 2004. In addition, filing occurred in the US on April 10, 2006, for use of Avastin in previously untreated advanced non-squamous, non-small cell lung cancer, on May 26 for treatment of women with advanced breast cancer and in Japan on April 21, 2006 for use of Avastin in patients with advanced or recurrent colorectal cancer.

    Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant i.e. post-operative). The total development programme is expected to include over 25,000 patients worldwide.

    Roche in Oncology

    The Roche Group, including its members Genentech in the United States and Chugai in Japan, is the world's leading provider of cancer care products, including anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented five products proven to provide survival benefit in different major tumour indications: Avastin, Herceptin, and Xeloda in advanced-stage breast cancer, Herceptin in early-stage HER2-positive breast cancer, MabThera in non-Hodgkin's lymphoma, Avastin and Xeloda in colorectal cancer, Avastin and Tarceva in non-small cell lung cancer and Tarceva in pancreatic cancer.

    In addition to these anti-cancer agents, the Roche oncology portfolio includes a comprehensive collection of medicines that can help improve the quality of life of cancer patients: Bondronat (for prevention of skeletal events in patients with breast cancer and bone metastases, hypercalcaemia of malignancy), Kytril (for chemotherapy and radiotherapy-induced nausea and vomiting), Neupogen (for cancer-related neutropenia), and NeoRecormon (for anaemia in various cancer settings). CERA is the most recent demonstration of Roche's commitment to anaemia management. Other oncology products include Furtulon (for colorectal cancer) and Roferon-A (for hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma).

    In addition to the medicines, Roche is developing new diagnostic tests that will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics.

    The unmatched Roche oncology portfolio as well as an extensive external innovation base through collaborations with companies and academia is what makes it possible for Roche to provide more effective cancer therapies.

    In the United States Herceptin, MabThera (Rituxan), Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improve people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

    All trademarks used or mentioned in this release are legally protected.

    Reference:

    1) Fehrenbacher, C et al, A phase II, multicenter, randomized clinical trial to evaluate the efficacy and safety of Avastin (bevacizumab) in combination with either chemotherapy (docetaxel or pemetrexed) or Tarceva (erlotinib hydrochloride) compared with chemotherapy alone for treatment of recurrent or refractory non-small cell lung cancer, Abstract #7062, presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) 2006.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
Christine Hill, International Communications Manager, Avastin, Roche
Pharmaceuticals, Telephone: +41-616-888-995, Mobile: +41-797-888-245,
Email: Christine.mage-hill@roche.com. Martin McInally, International
Communications Manager, Tarceva, Roche Pharmaceuticals, Telephone:
+41-797-888-208, Mobile: +41-797-888-208, Email:
martin.mcinally@roche.com



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