Merck, a leading science and technology company, today announced that ERBITUX (cetuximab) has been granted approval by the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in combination with platinum-based therapy with fluorouracil. Evidence from the pivotal Phase III CHANGE II study, on which the approval is based, shows the efficacy and safety of the EXTREME regimen vs platinum-based chemotherapy (cisplatin + 5-FU) alone for first-line treatment in Chinese patients with head and neck cancer. The data showed that the addition of ERBITUX to platinum-based chemotherapy improved progression-free survival (PFS), overall survival (OS) and overall response rate (ORR), confirming the relevance of the EXTREME regimen specifically in this patient population.1 

"ERBITUX in combination with platinum-based therapy is a preferred treatment option for patients with R/M SCCHN globally and the CHANGE II study further demonstrates the benefits it can bring in the first-line setting for patients in China," said Professor Ye Guo, Shanghai East Hospital, Tongji University, China and principal investigator in the CHANGE II study. "The approval of ERBITUX in a first-line setting marks an important development for Chinese patients, who now have access to a new treatment option."

"ERBITUX® and the EXTREME regimen play an important role in the treatment of patients with R/M SCCHN. We welcome the National Medical Products Administration's decision to make it available to Chinese patients in the first-line setting," said Chris Round, Head of International Operations and Global Core Franchises, Merck, operating in China. "This approval marks a significant step forward in fulfilling our commitment as a global specialty innovator, including bringing medicines to markets with high unmet medical needs."

The approval is based on the CHANGE II study of 243 randomized patients (164 patients in the ERBITUX® + platinum-based chemotherapy arm versus 79 patients in the platinum-based chemotherapy only arm) from China with R/M SCCHN, which found that adding ERBITUX to platinum-based chemotherapy improved progression-free survival 

CHANGE II is the first Phase III trial in the Chinese population to prospectively evaluate an anti-epidermal growth factor receptor (EGFR) antibody in the first-line treatment of patients with head and neck cancer. The data are consistent with previous international pivotal studies and reaffirm the efficacy of ERBITUX in combination with platinum-based therapy with fluorouracil for patients with R/M SCCHN.

In 2019, ERBITUX was made available in China for the first-line treatment of patients with RAS wild-type metastatic colorectal cancer in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.