Roche announced that the European Commission has approved the use of Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

The pivotal phase II JO25567 study showed a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015) for people treated with the combination of Avastin plus Tarceva compared to Tarceva alone. Avastin and Tarceva each target pathways which are known to be key drivers in the development and growth of tumours. The beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable.

“The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer,” said Sandra Horning, M.D., chief medical officer and global head of product development. “This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond one year, representing important progress for a group of patients who typically face a poor prognosis.”

Each year, an estimated 23,000 Europeans are diagnosed with non-squamous NSCLC with EGFR-activating mutations, the equivalent of more than 60 diagnoses every day. NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world. Of all cancers, lung cancer has the greatest global economic and societal impact, making improvements in outcomes for patients with lung cancer a key global healthcare challenge.

JO25567 is a randomised phase II study conducted by Chugai that assessed the safety and efficacy of first-line Avastin in combination with Tarceva compared to Tarceva alone in Japanese patients with advanced non-squamous NSCLC with EGFR-activating mutations. Study data from 154 patients showed:

Patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing (progression-free survival, PFS)(primary endpoint) compared to those who received Tarceva alone, representing a statistically significant 46 percent reduction in the relative risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015).

No new and clinically significant adverse events were observed and the toxicity profile was shown to be managable.

Lung cancer is the leading cause of cancer-related death in Europe and across the world. In Europe, it kills more people than breast and prostate cancers combined.4 Each year, over a quarter of a million people die as a result of the disease, equating to more than 700 deaths every day in Europe. NSCLC is the most common type of lung cancer and accounts for 85 percent of all lung cancer diagnoses.

Epidermal growth factor receptor (EGFR) is a protein that sits across the cell membrane and forms part of normal cell signalling. NSCLC with EGFR-activating mutations occurs when there is a mutation in a specific area of DNA in the EGFR gene (commonly exon 19 and exon 21), which leads to a change in the structure and function of the EGFR proteins and results in EGFR signalling being constantly active. This can cause accelerated cell growth and division, angiogenesis and the development of metastases. Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year.

With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and platinum-resistant, recurrent ovarian cancer. In addition, Avastin is approved in over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over two million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

Tarceva is a once-daily, oral non-chemotherapy medicine for the treatment of advanced or metastatic NSCLC. It has been shown to inhibit EGFR, a protein involved in the growth and development of cancers.

Tarceva is developed and commercialised by Astellas Pharma US in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.