ERBITUX(R) 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)

PR83105

DARMSTADT, Germany, Mar. 2, 2020 /PRNewswire=KYODO JBN/--

Not intended for UK-based media

- Approval is for ERBITUX(R) 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(R) 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

Merck, a leading science and technology company, today announced that

ERBITUX(R) (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

(ERBITUX(R) + cisplatin + 5-FU, followed by ERBITUX(R)  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(R) 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(R) 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(R) in a first-line setting

marks an important development for Chinese patients, who now have access to a new

treatment option."

"ERBITUX(R) 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(R) + 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(R)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(R) in combination with platinum-based

therapy with fluorouracil for patients with R/M SCCHN.

In 2019, ERBITUX(R) 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

greater than or equal to 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(R)(cetuximab)

ERBITUX(R) is an IgG1 monoclonal antibody targeting the epidermal growth factor

receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX(R) 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(R) also targets cytotoxic immune effector cells towards

EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX(R) 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(R), 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 plus or minus 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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Contact: Annemarie Eckhardt

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         +49-6151-72-26560  

SOURCE: Merck KGaA