Encouraging results from a Phase II study of Erbitux in combination with chemotherapy in non-small cell lung cancer has encouraged its developer, ImClone Systems, to move ahead with continued development in this indication.
Erbitux (cetuximab), sold by ImClone and Bristol-Myers Squibb in the USA and Merck KGaA in Europe, is already approved for treating colorectal cancer and head and neck cancer. Merck also said it would press on with developing Erbitux for lung cancer on the back of encouraging data presented at the American Society of Clinical Oncology annual meeting.
ImClone’s trial involved 225 previously-untreated patients with advanced NSCLC who were randomised to receive either Erbitux plus chemotherapy or sequential treatment with chemotherapy followed by Erbitux.
Median survival in the Erbitux plus chemotherapy arm of the trial was 10 months, meeting the primary endpoint, while median survival in the sequential arm was 9 months.
Meanwhile, the median time to progression of disease was the same in both treatment groups at four months, said ImClone.
Meanwhile, Merck presented data from a clinical trial involving 1,147 patients with metastatic colorectal cancer who had failed prior treatment using irinotecan. This showed that Erbitux and irinotecan in combination yielded a median survival of 9.2 months.
"These results clearly confirm in more than 1,000 patients the efficacy and safety of Erbitux plus irinotecan in pretreated patients and provides further evidence that Erbitux is delivering on its promise," Merck said in a statement.
The German drugmaker said it was testing Erbitux in Phase III trials involving more than 4,000 patients, including the FLEX study which is examining the survival benefits of first-line use of Erbitux with chemotherapy (cisplatin and vinorelbine) versus chemotherapy alone in 1,125 patients with advanced NSCLC.