Merck KGaA, Darmstadt, Germany Data at ESMO Asia on ERBITUX® Show Improved Survival in Chinese Patients with Recurrent and/or Metastatic Head & Neck Cancer
- New Phase III results demonstrated efficacy and safety of ERBITUX® plus platinum-based chemotherapy (EXTREME regimen) in 1st line R/M SCCHN vs chemotherapy alone in Chinese patients
- Merck KGaA, Darmstadt, Germany will file for registration with the Chinese National Medical Products Administration (NMPA) to make the EXTREME regimen available to R/M SCCHN patients in China
Darmstadt, Germany, November 23, 2018 – Merck KGaA, Darmstadt, Germany, the science and technology company, today announced positive new Phase III data assessing the efficacy and safety of ERBITUX® plus platinum-based chemotherapy (known as ‘EXTREME’), an established standard of care in many countries of the world, for first-line treatment of Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) at the ESMO (European Society for Medical Oncology) Asia 2018 Congress, Singapore, November 23–25.1
CHANGE II, a randomized, multicenter, open-label Phase III trial, assessed the efficacy and safety of the EXTREME regimen vs platinum-based chemotherapy (cisplatin + 5-FU) alone for first-line treatment in 243 Chinese patients with R/M SCCHN. The data showed that the addition of ERBITUX® to platinum-based chemotherapy improved progression-free survival (median 5.5 vs 4.2 months; hazard ratio [HR]=0.57; 95% confidence interval [CI]: 0.40–0.80), overall survival (median 10.2 vs 8.4 months; HR=0.71; 95% CI: 0.50–0.99) and overall response rate (50% vs 27%) with no new or unexpected safety findings, confirming the relevance of the EXTREME regimen specifically in this patient population.1
“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, Shanghai East Hospital, Tongji University, China. “The CHANGE II study has demonstrated superior results for the EXTREME regimen specifically for Chinese patients with recurrent or metastatic squamous cell carcinoma of the head and neck when compared with standard chemotherapy treatment – the current standard of care in China.”
The CHANGE II data further reinforce the role of ERBITUX®, and the EXTREME regimen, an established standard of care in first-line R/M SCCHN in many countries of the world, supported by international guidelines and consistent Phase III and real-world data. These positive results in head and neck cancer closely follow the recent national reimbursement of ERBITUX® in China for metastatic colorectal cancer (mCRC).
“We are excited about these positive results from the CHANGE II study confirming the role of ERBITUX® and the EXTREME regimen for Chinese patients,” said Luciano Rossetti, Head of Global Research & Development at the Biopharma business of Merck KGaA, Darmstadt, Germany. “We are now planning interactions with the Chinese National Medical Products Administration (NMPA) to discuss how best to make this treatment formally available to Chinese patients, continuing our commitment to bring transformative cancer treatments to patients who can benefit from them most.”
- 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.
Our Supervisory Board has elected Michael Kleinemeier (66) as its Chairman. He was Member of the SAP SE Executive Board from 2015 to 2020.