ERBITUX® Approved for First-line Use in China in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

Approval is for ERBITUX® in combination with platinum-based therapy with fluorouracil for the first-line treatment of R/M SCCHN

Pivotal Phase III study shows significant improvements with ERBITUX® in combination with platinum-based therapy with fluorouracil in response rate,disease progression and survival compared to platinum-based chemotherapy alone

This marks a meaningful step forward in Merck's commitment as a global specialty innovator - including bringing innovative medicines to markets with high unmet medical needs

DARMSTADT,Germany,March 2,2020 --

Not intended for UK-based media

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 pivotalPhase III CHANGE II study,on which the approval is based,shows the efficacy and safety of the EXTREME regimen (ERBITUX®+ cisplatin + 5-FU,followed by ERBITUX®maintenance) vs platinum-based chemotherapy (cisplatin + 5-FU) alone for first-line treatment in Chinese patients with R/M SCCHN. 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,Chinaand 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 (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.1

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 R/M SCCHN. The data are consistent with previous international pivotal studies and reaffirm the efficacy of ERBITUX® in combination with platinum-based therapy with fluorouracilfor 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.

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 recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The trial included 243 patients in China ≥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 an 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]).

ERBITUX® has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck 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.

References

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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