Merck has presented the results of phase 3 clinical trial assessing the efficacy and safety of Erbitux (Ingredient: Cetuximab), and platinum-based chemotherapy for Chinese patients with recurrent and/or metastatic head and neck cancer.
The trial, titled CHANGE II, was a randomized, multicenter, open-label trial, which assessed the efficacy and safety of the Erbitux and platinum-based chemotherapy, also known as EXTREME, against platinum-based chemotherapy alone as first-line treatment in 243 Chinese patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), the company said Tuesday.
As a result, Erbitux and platinum-based chemotherapy had improved progression-free survival rates compared to platinum-based chemotherapy alone (5.5 months vs. 4.2 months). The combination therapy had better overall survival (10.2 vs. 8.4 months) and overall response rate (50 percent vs. 27 percent) with no new or unexpected safety findings.
“We are hopeful these results will help to bring the EXTREME regimen to China in a patient population where an unmet need for wider and more efficacious options in first-line treatment still exists,” said Professor Ye Guo of the Shanghai East Hospital in China.
The CHANGE II study has demonstrated superior results for the EXTREME regimen specifically for Chinese patients with R/M SCCHN when compared with standard chemotherapy treatment, which is the current standard of care in China, he added.
The company noted that the CHANGE II data further reinforce the role of the EXTREME regimen, which is already an established standard of care in first-line R/M SCCHN treatment in many countries.