Merck's oncology product lineup data presented on ASCO21 highlights major advances in cancer treatment

BAVENCIO ’s approved indications The
European Commission (EC) has approved BAVENCIO monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have not progressed after platinum-containing chemotherapy
.
BAVENCIO combined with axitinib is suitable for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC)
.
EC also approved BAVENCIO monotherapy for the treatment of adult patients with metastatic Merck cell carcinoma (MCC)
.

In the United States, BAVENCIO is suitable for the maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) patients who have not progressed after first-line platinum-containing chemotherapy
.
BAVENCIO is also suitable for the treatment of locally advanced or metastatic UC patients with disease progression during or after platinum-containing chemotherapy, or disease progression within 12 months after platinum-containing chemotherapy neoadjuvant or adjuvant therapy
.

Also in the United States, BAVENCIO combined with axitinib is suitable for the first-line treatment of patients with advanced RCC
.
In addition, the US Food and Drug Administration Administration ( the FDA ) to speed up the trial for the treatment of metastatic MCC BAVENCIO adults 12 years and older and children patients
.
This indication is based on the tumor remission rate and duration of remission, and was approved after an accelerated trial
.
The enduring approval of this indication may depend on the verification and description of clinical benefits by confirmatory trials
.

BAVENCIO is currently approved for at least one use in 50 countries
.

European summary of product characteristics (SmPC) in BAVENCIO security
special warnings and precautions BAVENCIO monotherapy include: Infusion-related reactions, and immune-related adverse events, which include: pulmonary interstitial inflammation and hepatitis (including fatal cases), Colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrine diseases, nephritis and renal insufficiency, and other immune-related adverse reactions
.
Special warnings and precautions for BAVENCIO combined with axitinib include liver toxicity
.

In the SmPC list, the most common adverse reactions of BAVENCIO monotherapy in patients with solid tumors include fatigue, nausea, diarrhea, loss of appetite, constipation, infusion-related reactions, weight loss, and vomiting
.
The most common adverse reactions of BAVENCIO combined with axitinib include: diarrhea, hypertension, fatigue, nausea, speech disorders, loss of appetite, hypothyroidism, cough, headache, dyspnea, and joint pain
.

About TEPMETKO ^®  (tepotinib)
TEPMETKO is an oral MET inhibitor that inhibits oncogenic MET receptor signaling caused by MET (gene) mutations
.
TEPMETKO was discovered and developed internally by Merck in Darmstadt, Germany.
It has a highly selective mechanism of action and is expected to improve the outcome of aggressive tumors with poor prognosis that carry the above-mentioned specific mutations
.

TEPMETKO is the world's first oral MET inhibitor approved by regulatory authorities for the treatment of advanced NSCLC with MET gene mutations
.
It was approved in Japan in March 2020 .
In February 2021, TEPMETKO was approved in the United States for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with skipping mutations in exon 14 of mesenchymal-epidermal transition ( MET )
.
The indication is based on the total remission rate and duration of remission, which was approved after an accelerated review
.
The long-term approval of this indication may depend on the verification and description of clinical benefits by confirmatory trials
.
Tepotinib is currently under clinical research and has not been approved in any markets outside of Japan and the United States
.

About Erbitux ^® (cetuximab)
Erbitux ^® is IgG1 targeting a growth factor receptor (EGFR) monoclonal antibody in the epidermis
.
As a monoclonal antibody, Erbitux ^® mode of action different from the standard non-selective chemotherapy, because it specifically targets the binding to and of EGFR
.
This combination can inhibit receptor activation and subsequent signal transduction pathways, thereby simultaneously reducing the invasion of tumor cells to normal tissues and the spread of tumors to new sites
.
It is believed that it can also inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy, and inhibit the formation of new blood vessels within the tumor , or can suppress tumor growth overall
.
According to in vitro evidence, Erbitux ^® may also be cytotoxic immune effector cells to target tumor cells expressing EGFR guide (antibody-dependent cell-mediated cytotoxicity [the ADCC])
.

Erbitux ^® has been approved for marketing in more than 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and the treatment of head and neck squamous cell carcinoma
.
In 1998, Merck authorized Eli Lilly and Company (Eli Lilly and Company), a wholly owned subsidiary of ImClone LLC, the sale of Erbitux outside the US and Canada ^® (a registered trademark of ImClone LLC)
.

About bintrafusp Alfa
bintrafusp alfa (M7824) is a potential first-of-its-kind dual-function fusion protein discovered by Merck, designed to block the two immunosuppressive pathways of TGF-β and PD-L1 in the tumor microenvironment at the same time.
Clinical development is currently being carried out through a strategic alliance with GSK
.
It is believed that this dual-function approach can control tumor growth by potentially restoring and enhancing anti-tumor responses
.
Preclinical studies have shown that bintrafusp alfa monotherapy and combination chemotherapy have anti-tumor activity
.
Based on its mechanism of action, bintrafusp alfa is expected to respond to the basic pathophysiology of refractory cancer through targeted methods
.