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New Findings/Tarceva Delivers Benefits Broad Range NSCLC Pts

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New data presented at ASCO 2008 from TRUST1, the largest non-small cell lung cancer (NSCLC) Phase IV trial ever conducted, show that a broad range of NSCLC patients treated with Tarceva (erlotinib) experience clinical benefits including longer survival, better quality of life, control of disease symptoms and control of cancer progression. NSCLC is the most common and deadly form of lung cancer suffered by over one million people worldwide2.

This analysis of 6,809 patients in 52 countries across Asia, Europe and the Americas showed that Tarceva's beneficial effects are not limited to certain subgroups, but extend to all types of patients with this debilitating disease1.

Patients across a broad range of clinical characteristics - gender, ethnicity, smoking status or tumor histology - lived an average of 14.3 weeks1 without their disease progressing (progression-free survival or PFS). While TRUST is a single-arm study, a PFS of 14.3 weeks is almost double the PFS (7.2 weeks) seen in the control arm of the landmark BR.21 study3 which resulted in Tarceva's approval four years ago.

In addition, all patient groups in TRUST (including male current and former smokers, and males who have never smoked) experienced an impressive disease control rate (DCR) of approximately 70% at the time of analysis1. DCR measures if the tumor disappeared, reduced in size or did not progress, and is strongly associated with increased survival and quality of life.

"These results underline that Tarceva is a very valuable drug with proven efficacy and safety in the fight against NSCLC," said Dr Martin Reck of the Department of Thoracic Oncology, Hospital Grosshansdorf, Germany. "TRUST demonstrates in routine day-to-day practice that Tarceva delivers benefits across a wide range of patients irrespective of clinical characteristics."

Realizing Tarceva's Potential

Another important study unveiled at ASCO is FAST-ACT4, a phase II trial of Tarceva administered sequentially with platinum-based chemotherapy to Asian patients. The study showed a significant improvement with patients on Tarceva living 7.2 months without their disease progressing. The FAST-ACT study is the first time that an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) has shown promise in first-line NSCLC when administered sequentially with standard chemotherapy. FAST-ACT also points to Tarceva's potential across multiple treatment settings.

In a global alliance comprising OSI Pharmaceuticals, Genentech and Roche, almost 130 clinical studies are being conducted with Tarceva at earlier stages of the disease and in combination with other treatments including Avastin, to further evaluate its life-extending benefits for patients with lung cancer.


TRUST, the largest ongoing study of Tarceva in lung cancer worldwide, involves over 7,000 NSCLC patients from 52 countries across Asia, Europe and the Americas. It is a multi-center, global, Phase IV study of Tarceva for the second- or third-line treatment of patients with advanced NSCLC. Also an expanded access program, TRUST enabled thousands of patients worldwide with advanced NSCLC to receive early access to Tarceva by filling the gap between the submission date of the new drug application and the date of final approval.


FAST-ACT is a Phase II randomized, double-blind trial of sequential Tarceva and chemotherapy as first-line treatment in Asian patients with stage IIIB/IV NSCLC. The study involved 154 patients enrolled from Australia and throughout Asia.

About BR.21

EU approval for Tarceva was based on a pivotal Phase III study, BR.21, published in the New England Journal of Medicine. BR.21 was conducted by the National Cancer Institute of Canada Clinical Trials Group, in collaboration with OSI Pharmaceuticals, with the participation of 86 sites from 17 countries around the world. This study involved 731 patients with advanced NSCLC whose cancers had progressed after first- or second-line chemotherapy and compared patients receiving Tarceva monotherapy with placebo.

The key study results were:

- Treatment with Tarceva in patients with advanced NSCLC resulted in significantly longer survival compared to placebo, a 42.5% improvement (6.7 months vs. 4.7 months).

- 31% of patients receiving Tarceva were alive at one year compared to 22% in the placebo arm.

- Patients receiving Tarceva had stability or control of their lung cancer-related symptoms such as cough, shortness of breath and pain, for significantly longer.

- Patients also had a superior quality of life and improved physical function compared to those on placebo.

- The benefits of Tarceva were shown in a broad spectrum of patients

About Tarceva

Tarceva is the first and only EGFR oral targeted agent with proven and significant survival and symptom benefit in a broad range of patients with advanced lung and pancreatic cancer. Currently most lung and pancreatic cancer patients are treated wholly with chemotherapy which can be very debilitating due to its toxic nature. Tarceva works differently than chemotherapy by specifically targeting tumor cells, and avoids most of the typical side-effects of chemotherapy.

Tarceva has been approved in the European Union 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. Furthermore, 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 its initial launch four years ago, Tarceva has been used to treat more than 200,000 patients and has been approved in 85 countries worldwide.

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(Medical News Today, Lung Cancer, Cancer/Oncology/Respiratory/Asthma, June 1, 2008)


The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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Targeted treatments like Tarceva, take advantage of the biologic differences between cancer cells and healthy cells by "targeting" faulty genes or proteins that contribute to the growth and development of cancer. Many times these drugs are combined with chemotherapy, biologic therapy (immunotherapy), or other targeted treatments.

Clinicians consider the biology of the tumor cell along with the site of the tumor when determining treatment. They are learning that the same enzymes and pathways are involved in many types of cancer. However, understanding targeted treatments begins with understanding the cancer cell. In order for cells to grow, divide, or die, they send and receive chemical messages. These messages are transmitted along specific pathways that involve various genes and proteins in a cell.

Targeted treatments fight cancer by correcting or modifying defective pathways in a cancer cell. In healthy cells, each pathway is tightly controlled. In cancerous cells, certain points in the pathway become disrupted, usually through a genetic mutation (change in form).

Serious consequences to the cell may result from these mutations, depending on which pathway is affected. For example, suppose a cell develops a mutation that causes it to continue dividing into new cells? In other words, the signal is always on. If the signal never turns off, the cells that keep growing may eventually form a tumor.

Because many cancer cells use similar pathways, the same drug could be used to treat one person's breast cancer and another person's lung cancer, as long as each tumor contained similar targets. This is why many of these treatments are being used in a variety of cancer types.

There is a challenge though, to identify which patients the targeted treatment will be effective. Initially, when Iressa or Tarceva was used in patients with lung cancer, researchers discovered that only patients whose tumors contained specific mutations responded to the drug. This new research data may confirm that this is not necessarily true. Patients across a broad range of clinical characteristics could benefit.

The introduction of targeted drugs has not been accompanied by specific predictive tests allowing for a rational and economical use of these drugs. However, given the technical and conceptual advantages of cell-based functional analysis, together with its performance and the modest efficacy of therapy prediction on analysis of genome expression, there is reason for a renewal in the interest of Oncologic In Vitro Chemoresponse Assays for optimized use of medical treatment of malignant disease.

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