- Guo Y, Luo Y, Zhang Q et al. First-line (1L) cisplatin and 5-FU ± cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): the randomized, Phase III CHANGE II trial. LBA6. Presented Saturday, November 24, 2018. Session Time: 3:30-4:20PM Room 311. ESMO Asia 2018.
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About Change II
Change II is a multicenter, randomized, open-label, Phase III trial assessing the efficacy and safety of the EXTREME regimen vs platinum-based therapy for Chinese patients with first-line line recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The trial included 243 Chinese ≥18 years of age with histologically confirmed R/M SCCHN and no prior systemic chemotherapy for R/M disease. The primary objective was to demonstrate superior PFS time per Response Evaluation Criteria on Solid Tumors (RECIST).
About Erbitux® (cetuximab)
Erbitux® is a IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux® is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, Erbitux® also targets cytotoxic immune effector cells towards EGFR expressing tumor cells (antibody dependent cell-mediated cytotoxicity, ADCC).
Very commonly reported side effects with Erbitux® include acne-like skin rash, mild to moderate infusion related reactions and hypomagnesaemia.
Erbitux® has already obtained market authorization in over 100 countries world-wide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck KGaA, Darmstadt, Germany licensed the right to market Erbitux, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, the vibrant science and technology company, operates across healthcare, life science and performance materials. Almost 53,000 employees work to make a positive difference to millions of peoples’ lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases, to enabling the intelligence of devices – the company is everywhere. In 2017, Merck KGaA, Darmstadt, Germany, generated sales of € 15.3 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the company operates as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.