Merck's Erbitux Approved in China as First-Line Therapy for Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

March 3, 2020 News /Bio ValleyBIOON/ -- German pharmaceutical giant Merck KGaA recently announced that the China National Medical Products Administration (NMPA) has approved the anticancer drug Erbitux (Chinese brand name: Erbitu; generic name: cetuximab), in combination with platinum-based chemotherapy and fluorouracil, for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

This approval is based on the results of the Phase III CHANGE II study, which evaluated first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in China. In this study, 243 patients were randomized to receive either Erbitux plus platinum-based chemotherapy (cisplatin + 5-FU) (n=164) or platinum-based chemotherapy alone (cisplatin + 5-FU) (n=79). The results demonstrated that adding Erbitux to platinum-based chemotherapy significantly improved efficacy as a first-line treatment for patients with R/M SCCHN. Specifically, compared with platinum-based chemotherapy (cisplatin + 5-FU), the EXTREME regimen (Erbitux + cisplatin + 5-FU, followed by Erbitux maintenance therapy) prolonged progression-free survival (median PFS: 5.5 months vs. 4.2 months; HR=0.57; 95% CI: 0.40–0.80), extended overall survival (median OS: 10.2 months vs. 8.4 months; HR=0.71; 95% CI: 0.50–0.99), and increased the overall response rate (ORR: 50% vs. 27%). No new or unexpected safety findings were observed in the study.

Notably, CHANGE II is the first phase III trial to prospectively evaluate an anti-epidermal growth factor receptor (EGFR) antibody as first-line treatment in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in the Chinese population.Clinical Trial. These data are consistent with previous international pivotal studies and reaffirm the efficacy of Erbitux in combination with platinum-based chemotherapy and fluorouracil regimens as first-line treatment for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN).

Professor Guo Ye from Shanghai East Hospital, Tongji University, the principal investigator of the CHANGE II study, stated, “Erbitux in combination with platinum-based chemotherapy is the preferred treatment regimen for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) worldwide. The CHANGE II study further demonstrates that this regimen provides first-line treatment benefits for Chinese patients. The approval of Erbitux for first-line treatment marks a significant advancement in the clinical management of R/M SCCHN in China, offering these patients access to a new therapeutic option.”

Chris Round, Head of International Business and Global Core Franchises at Merck KGaA, stated, “Erbitux and the EXTREME regimen have played a significant role in the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). We are delighted by the approval from China’s National Medical Products Administration (NMPA), which will provide a first-line treatment option for patients in China. This approval marks an important step forward in fulfilling our commitment as a global specialty innovation company, including bringing medicines to markets with unmet medical needs.”

Erbitux was launched in 2003 as the world’s first IgG1 monoclonal antibody targeting EGFR. As aMonoclonal Antibody Drugs, Erbitux differs from standard non-selective chemotherapeutic agents by targeting and binding to EGFR. This binding inhibits receptor activation and subsequent signal transduction pathways, thereby reducing tumor cell invasion into normal tissues and the spread of tumors to new sites. Furthermore, Erbitux is believed to inhibit the ability of tumor cells to repair damage caused by chemotherapy and radiotherapy, as well as to suppress the formation of new blood vessels within tumors, which appears to result in an overall inhibition of tumor growth. Based on in vitro evidence, Erbitux can also direct cytotoxic immune effector cells toward EGFR-expressingTumorCells (Antibody-Dependent Cell-Mediated Cytotoxicity, ADCC).

To date, Erbitux has been approved in more than 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer (RAS wt mCRC) and/or squamous cell carcinoma of the head and neck (SCCHN). Erbitux was developed by ImClone (nowEli Lillya wholly-owned subsidiary) developed it, and Merck KGaA was granted exclusive rights to Erbitux in markets outside the United States and Canada in 1998.

In China, Erbitux was approved in 2006 for the treatment of RAS wild-type metastatic colorectal cancer (RAS wt mCRC). Erbitux has been included in Category B of the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2017 Edition). In August 2019, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security issued the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2019 Edition), in which Erbitux is listed as a drug under negotiation during the agreement period. The reimbursement payment standard is RMB 1,295 per bottle (100 mg/20 mL), with the restricted payment scope limited to RAS wild-type metastatic colorectal cancer (RAS wt mCRC).

In September 2019, Erbitux was approved in China for new indications: (1) first-line treatment of RAS wild-type metastatic colorectal cancer (mCRC) patients in combination with FOLFOX (oxaliplatin + leucovorin + 5-FU) or FOLFIRI (irinotecan + leucovorin + 5-FU); (2) treatment of RAS wild-type mCRC patients who are refractory to irinotecan-containing chemotherapy regimens, in combination with irinotecan. (Bioon.com)

Original source: ERBITUXapproved for First-line Use in China in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)