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)

Darmstadt, Germany (ots/PRNewswire) - 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

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 pivotal Phase 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, China
and 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 fluorouracil for
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

1. 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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