Adding Avastin (bevacizumab) to a combination of Tarceva (erlotinib) and chemotherapy significantly improves the time patients with metastatic pancreatic cancer live without their disease getting worse (progression free survival). These data presented for the first time at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, also showed a trend towards extending life expectancy.
Pancreatic cancer is the sixth leading cause of cancer death in Europe1 and is extremely difficult to treat because it spreads rapidly to other parts of the body and often shows resistance to chemotherapy and radiotherapy2. It is also difficult to diagnose, with no effective early diagnostic test available3 so the majority of patients are diagnosed with advanced disease.
"For patients with advanced pancreatic cancer, the treatment options are limited," commented Professor Eric Van Cutsem, Professor of Medicine, Gastrointestinal Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium. "The interesting results show the need for further exploring which patients benefit from the combination of gemcitabine plus Avastin and Tarceva in view of the statistically longer PFS which trends towards improved survival."
The results of the phase III AVITA (BO17706) study showed that the addition of Avastin to a Tarceva/gemcitabine combination resulted in: A 37% increase in the time patients live without their disease getting worse compared to Tarceva/gemcitabine alone; Almost 14% of patients experiencing a complete disappearance or shrinkage of their tumour; A trend towards improved overall survival; No new safety signals for Avastin.
In addition, data from the Tarceva/gemcitabine control arm were consistent with previous results from the PA3 study, reinforcing the already established survival benefits of Tarceva in pancreatic cancer.
The AVITA (BO17706) study is a Roche-sponsored, randomized, double-blind, placebo-controlled phase III study that included 607 patients with metastatic pancreatic cancer. Study participants received first-line treatment with either gemcitabine, Tarceva and placebo or gemcitabine, Tarceva and Avastin (at 5mg/kg every two weeks).
The AVITA study did not meet its primary endpoint of overall survival (OS), however results showed that adding Avastin to a combination of Tarceva and chemotherapy significantly improved the time patients with pancreatic cancer lived without their disease getting worse (PFS). A trend towards improved OS was also observed.
In addition, the findings in the gemcitabine/Tarceva control arm of this trial were consistent with the efficacy observed in the metastatic patient population in the pivotal Phase III PA3 study led to the regulatory approval of Tarceva for the treatment of pancreatic cancer in the US in 2005 and in the EU in 2007.
Avastin directly inhibits vascular endothelial growth factor (VEGF), a key mediator of angiogenesis (the growth of new blood vessels). Blocking tumour angiogenesis with Avastin starves the tumour of the blood supply that is critical for its growth and spread throughout the body (metastasis). Because Avastin directly blocks tumour angiogenesis, a process common to all types of tumour development, it has the potential to deliver patient survival benefits in a variety of different cancer types. Roche is therefore pursuing a comprehensive clinical trial program investigating the use of Avastin in over 20 tumour types and different settings (advanced, post surgical). The total development program is expected to include over 40,000 patients world-wide and has already resulted in approvals in advanced colorectal, breast, lung, and kidney cancer.