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Avastin, Tarceva Trial Doesn't Meet Primary Endpoint November, 2007

Swiss drugmaker Roche Holding AG (RHHBY) said Tuesday that data from the phase III AVITA trial comparing gemcitabine chemotherapy and Tarceva (erlotinib) with or without Avastin (bevacizumab) as first-line treatment for advanced pancreatic cancer showed some evidence of clinical activity on secondary endpoints although the trial did not meet the primary endpoint of overall survival.

These results are in contrast to previously published data of Avastin in combination with gemcitabine (CALGB 80303) in advanced pancreatic cancer.

In the CALGB trial, Avastin neither improved progression-free nor overall survival. Data from the AVITA trial are now being further analysed to determine the extent of benefit of adding Avastin to the Tarceva/gemcitabine combination therapy. No new safety events were observed with the addition of Avastin in the AVITA trial. Full data from AVITA will be presented at a future major oncology conference.

The findings in the gemcitabine/ Tarceva control arm of this trial were consistent with the efficacy observed in the metastatic patient population in the PA.3 study. This pivotal phase III study led to the regulatory approval of Tarceva in the US in 2005 and in the EU in 2007. Tarceva, in combination with gemcitabine, is the only drug in over a decade to show a significant survival benefit in patients with the devastating disease of pancreatic cancer.

Pancreatic cancer is the sixth most frequently occurring cancer in Europe and is extremely difficult to treat as it is often resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body, , leading to high mortality and the shortest life expectancy of any major tumour.

Both Roche and Genentech are committed to the continuing development of Avastin and are pursuing a comprehensive clinical programme investigating its use in various tumour types (including colorectal, breast, lung, ovarian, kidney and other cancer types) and different settings (advanced and adjuvant i.e., post-operation). The total development programme is expected to include over 40,000 patients worldwide.

Avastin has already demonstrated a progression-free and/or overall survival benefit for patients in four cancer types, namely: colorectal, breast, lung, and renal cell cancer which resulted in approvals in the EU for colorectal, breast and lung cancers.

AVITA (BO17706) is a Roche-sponsored randomised, double blind, placebo controlled study of gemcitabine and Tarceva with or without Avastin in patients with metastatic pancreatic cancer. The study included 607 patients. The primary endpoint was overall survival, secondary endpoints included amongst others PFS and safety.

Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply 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).

Approval status:

February 2004 (US) and January 2005 (EU) - first-line treatment in patients with metastatic colorectal cancer

June 2006 (US) - second-line treatment in patients with metastatic colorectal cancer

October 2006 (US) - first-line treatment in patients with advanced non-small cell lung cancer (NSCLC)

March 2007 (EU) - first-line treatment in patients with metastatic breast cancer

April 2007 (Japan) -treatment in patients with advanced or recurrent colorectal cancer.

August 2007 (EU) - first-line treatment in patients with advanced NSCLC.

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 to chemotherapy by specifically targeting tumour cells, and avoids the typical side-effects of chemotherapy.

Tarceva is 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 show a significant survival benefit in 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 three years ago, Tarceva has been approved in over 80 countries and used to treat more than 200,000 patients worldwide.

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