Tarceva™ is a small molecule, anti-epidermal growth factor receptor (EGFR) drug candidate that has demonstrated encouraging anti-cancer activity in single agent, open label Phase II studies in NSCLC, head and neck cancer and ovarian cancer.
The TALENT (Tarceva Lung Cancer Investigation) trial will measure whether Tarceva™ improves the duration of survival for patients with non-small cell lung cancer (NSCLC). The multi-centre, 1,000 patient study is one of two randomised, controlled Phase III trials in NSCLC that will assess the value of adding Tarceva™ to two of the most commonly used front-line combination chemotherapy regimens for NSCLC (gemcitabine/cisplatin and carboplatin/paclitaxel). A previous open label Phase II study with single agent Tarceva™ in lung cancer has shown that the drug has encouraging anti-tumour activity – with 48% of 57 patients showing either a full response or disease stabilisation.
Lung cancer kills more men annually than prostate cancer and more women than breast cancer. NSCLC is the most common form of lung cancer and a high proportion of these patients express the EGFR gene, a protein strongly implicated in human cancer.
The TACTIX (Tarceva in Combination with Taxotere and Xeloda) trial, a Phase 1b study, will look at the feasibility of combining Tarceva™ with chemotherapy in patients with advanced breast cancer who have relapsed after initial chemotherapy treatment. The study will take place in Spain and in the UK.
Lead investigator for the breast cancer study in Spain, Dr Jose Baselga from the Department of Medical Oncology, Vall d'Hebron University Hospital in Barcelona, said:
"We are very excited about the potential of Tarceva to improve outcomes for patients in a number of different solid tumours. The fact that Tarceva is well tolerated compared to ordinary chemotherapy makes adding it to existing treatment regimens possible."
Breast cancer is the leading cause of death in women aged 35-55, and the second leading cause of death in women of all ages. In Europe alone breast cancer is estimated to claim over 165,000 lives each year.
Notes to editors 1. Since the Roche/Genentech/OSI alliance began in January this year, several clinical studies have been initiated with Tarceva™, a Phase II metastatic breast cancer trial, two Phase III front-line combination studies with Tarceva? in NSCLC, and four Phase 1b trials which are to determine the safety, tolerance and pharmacokinetics and preliminary anti-cancer activity of escalating doses of Tarceva™ in combination with various chemotherapies. Additional Phase III studies in pancreatic cancer and refractory NSCLC are expected to begin in 2001.
2. Tarceva™ has demonstrated encouraging anti-cancer activity in an open label, single agent Phase II study of patients who had failed at least one round of platinum-based chemotherapy. In data presented at this year’s American Society of Clinical Oncology meeting in May, one complete response and eight partial responses (two unconfirmed) were seen in 57 evaluable patients. In addition, 15 patients demonstrated evidence of disease stabilisation for periods of three or more months. Median survival of the patients in this study was 257 days and statistical analysis indicated a one year survival rate of 48% for patients in this uncontrolled study.
3. Tarceva™ targets the Epidermal Growth Factor Receptor (EGFR) tyrosine kinase, over-expressed in a third of cancer tumour types. In many types of cancer, tumour cells are stimulated to survive and multiply by special signals sent to the cell nucleus (the control centre of the cell). Tarceva™ works by stopping one of these signals from being sent to the nucleus, preventing continued tumour growth. The particular signal Tarceva stops comes from the EGFR and so Tarceva? belongs to a new class of drugs called EGFR inhibitors. EGFR is present in many solid tumours and therefore Tarceva™ has potential as an anticancer agent in many different types of cancer.
4. Roche is a world leader in oncology. Its franchise comprises products such as Xeloda ? (breast cancer and colorectal cancer), Herceptin? (breast cancer), MabThera™ (non-Hodgkin’s lymphoma), NeoRecormon™ (anemia in cancer patients), Roferon-A™ (leukemia, Kaposi’s sarcoma, malignant melanoma), Bondronat? (tumour-induced hypercalcemia), Furtulon? (malignant tumours, only available in Japan) and the anti-emetic drug Kytril™ (used in chemotherapy induced emesis).
These medicines along with a number of diagnostics tests have made Roche one of the industry’s most innovative and comprehensive companies in the field of oncology.
For more information please visit www.roche.com
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