ImClone announced that late-stage study data showed that first-line treatment with Erbitux (cetuximab) plus standard chemotherapy significantly increased overall survival by about five weeks in patients with advanced non-small cell lung cancer (NSCLC), compared with chemotherapy alone. The results were presented at the American Society of Clinical Oncology (ASCO) meeting this weekend.
To put things in context, the American Cancer Society estimates that in the United States, more than 215,000 people will be diagnosed with lung cancer in 2008, which accounts for about 15 percent of all cancer diagnoses. Approximately 87 percent of these patients will be diagnosed with NSCLC, with many being diagnosed with locally advanced or metastatic disease. Lung cancer is the leading cause of cancer-related death in men and women, with more than 161,000 deaths expected to occur in 2008 – accounting for about 29 percent of all cancer deaths. In 2008, it is estimated that more Americans will die from lung cancer than breast, prostate, and colorectal cancers combined. Studies showing a significant improvement in survival will therefore impact the course of disease and affect large numbers of patients.
The randomised FLEX study involved 1125 patients with advanced non-small cell lung cancer (NSCLC) who had not previously received chemotherapy. The data demonstrated that those who received ImClone announced that Erbitux combined with chemotherapy resulted in a median overall survival of 11.3 months, compared with 10.1 months for chemotherapy alone, a significant difference. The findings also showed that tumours shrank in 36.3 percent of patients who received the Erbitux regimen, compared with 29.2 percent of patients who only received standard chemotherapy.
It is unlikely that the findings are impressive enough to significantly affect the position of Genentech’s Avastin for patients with lung cancer who can be treated with the product in the short term. However, doctors treating patients with NSCLC who cannot take Avastin may opt to prescribe Erbitux, which could lead to an additional $700 million in annual sales in the US.
Overall, probably one in five patients or less get Avastin, so there’s a huge opportunity outside of that in the long run, and the data are very competitive. Erbitux is expected to be filed for expanded US approval in NSCLC in the second half of this year, and the new indication could be added to the label by mid-2009. If approved, this will open new first-line treatment options for patients with non-small cell lung cancer regardless of histological subtypes, and potentially set a new standard in the first-line treatment of this disease.