Merck's Erbitux® (Cetuximab) Approved in China for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Combination with Radiotherapy

On June 22, 2022, Merck announced that Erbitux® (Cetuximab Injection) had officially received approval from the National Medical Products Administration (NMPA) for use in combination with radiotherapy to treat patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). With the approval of this indication, Erbitux® has now secured four indications in China.

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common malignant tumor globally, with 835,000 cases, ranking eighth among cancer-related deaths. More than 90% of these are squamous cell carcinomas. According to the 2022 National Cancer Report in China, there were over 79,000 new cases of head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) in China, with over 40,000 deaths. Due to the insidious nature of its symptoms, HNSCC is difficult to detect early. Over 60% of patients with head and neck squamous cell carcinoma are diagnosed at an advanced stage, and 10% of patients have distant metastases.

"Currently, the treatment of locally advanced squamous cell carcinoma of the head and neck still faces many challenges," said Professor Guo Ye from the Department of Medical Oncology at East Hospital, Tongji University. "The current standard treatment for locally advanced squamous cell carcinoma of the head and neck is surgery combined with chemoradiotherapy. The clinical outcomes of chemoradiotherapy alone are not ideal, with 35-60% of patients experiencing recurrence, necessitating palliative care. Patients with locally advanced squamous cell carcinoma of the head and neck urgently need more effective treatments with better tolerability to improve treatment outcomes and enhance quality of life."

Erbitux® Approval Based on Bonner StudyThe approval of Erbitux® this time is mainly based on the Bonner study, a randomized, multi-center, global Phase III clinical trial. The study results showed that cetuximab combined with radiotherapy significantly improved local control (primary endpoint) and prolonged overall survival compared to radiotherapy alone. The 3-year local control rate for the combination of cetuximab and radiotherapy reached 47%, and the 5-year overall survival rate was 45.6%, both significantly better than the radiotherapy-alone group. In terms of safety, the combination of cetuximab and radiotherapy did not increase toxicity or affect quality of life compared to radiotherapy alone. Subgroup analysis of the Bonner study first indicated that cetuximab may have potential benefits for larynx preservation in SCCHN.