PR83878

DARMSTADT, Germany and NEW YORK, April 30 /PRNewswire=KYODO JBN/ --

- Not intended for US-, Canada- or UK-based media

- ASCO Abstract #

BAVENCIO® (avelumab): LBA1, 5061; Bintrafusp alfa (bifunctional fusion

protein): 9558; Tepotinib (MET kinase inhibitor): 9556, 9575.

- Late-breaking presentation of Phase III JAVELIN Bladder 100 data for

BAVENCIO® showing overall survival benefit in first-line maintenance treatment

of advanced urothelial carcinoma

- Primary efficacy and biomarker analyses from ongoing VISION study for

first-in-class tepotinib† in NSCLC with METex14 skipping alterations

- Two-year follow-up for novel bifunctional fusion protein targeting

TGF-B/PD-L1, bintrafusp alfa‡, in second-line treatment of NSCLC

- Data from investigational and approved agents showcase scientific

innovation of company's biology-driven portfolio across 11 tumor types with

high unmet need

Merck, a leading science and technology company, today announced 25

abstracts will be presented at the 2020 American Society of Clinical Oncology

(ASCO) Annual Meeting. These abstracts represent several innovative modalities

and mechanisms that have the potential to advance treatment across a range of

difficult-to-treat cancers. The meeting will be held virtually from May 29-31.

"We anticipate our late-breaking data for BAVENCIO® as first-line

maintenance therapy for urothelial carcinoma will be some of the most exciting

data to be shared at this year's ASCO meeting," said Luciano Rossetti, Global

Head of Research & Development for the Biopharma business of Merck. "In

addition, studies from our ongoing clinical trials in advanced lung cancer from

two of our in-house developed mechanisms—our oral MET inhibitor, tepotinib, and

our first-in-class bifunctional fusion protein immunotherapy targeting

TGF-B/PD-L1, bintrafusp alfa—reinforce the impact these investigational

medicines may have in one of the leading causes of cancer mortality."

The first presentation of detailed results from the Phase III JAVELIN

Bladder 100 study (Abstract #LBA1), which show an overall survival benefit for

BAVENCIO® (avelumab) versus best supportive care in the first-line maintenance

treatment of advanced urothelial carcinoma (UC)*, will take place during the

plenary session on Sunday, May 31. BAVENCIO is co-developed and

co-commercialized with Pfizer Inc.

Additional study findings will be presented for BAVENCIO in combination

with axitinib for advanced renal cell carcinoma (RCC) and for the Company's

first biology-driven leader, ERBITUX® (cetuximab), which continues to

demonstrate its legacy as the backbone of treatment of squamous cell carcinoma

of the head and neck (SCCHN) and its value across the continuum of care in

metastatic colorectal cancer (mCRC).

Data to be presented at ASCO for Merck's biology-driven portfolio, which

focuses on three discovery platforms, in oncogenic pathways, immuno-oncology

and DNA damage response inhibition (DDRi), continue to demonstrate

transformative potential to address current unmet needs in a number of

hard-to-treat tumor types through innovative treatment approaches and novel

combinations. These include potential first-in-class/best-in-class early- and

late-stage pipeline compounds and investigational uses of approved medicines

across a number of cancers including non-small cell lung cancer (NSCLC), UC,

RCC, Merkel cell carcinoma, SCCHN and mCRC.

*BAVENCIO is under clinical investigation for the first-line maintenance

treatment of advanced UC. There is no guarantee that BAVENCIO will be approved

for first-line maintenance treatment of advanced UC by any health authority

worldwide.

†Tepotinib is the International Nonproprietary Name (INN) for the MET

kinase inhibitor MSC2156119J. Tepotinib is currently under clinical

investigation in NSCLC and not yet approved in any markets outside of Japan.

‡Bintrafusp alfa is currently under clinical investigation and not approved

for any use anywhere in the world.

Notes to Editors

Key Merck-supported abstracts slated for presentation are listed below. In

addition, a number of investigator-sponsored studies have been accepted (not

listed).

Title                                          Lead Author                 Abstract #

Presentation Date / Time (All times EDT)

BAVENCIO (avelumab)

Oral Session

Maintenance avelumab             T Powles                      LBA1

Accepted for Plenary Session, Sunday, May 31 at 1 p.m.

+ best supportive care

Abstract available online at the ASCO Meeting Library from Thursday, May 28 at

5 p.m.

(Ave + BSC) vs BSC

alone

after platinum-based first-line

(1L) chemotherapy (CTx) in

advanced urothelial carcinoma

(aUC): results from the

JAVELIN Bladder 100 phase 3 trial

Poster Presentation

Association of neutrophil to          MA Bilen                   5061

ASCO Meeting Library, Wednesday, May 13 at 5 p.m

lymphocyte ratio (NLR) with

efficacy from JAVELIN Renal 101

Tepotinib

Poster Presentation

Tepotinib in patients (pts) with       PK Paik                    9575

ASCO Meeting Library, Wednesday, May 13 at 5 p.m.

NSCLC with MET exon 14 (METex14)

skipping: health-related quality

of life (HRQoL) (VISION PRO)

Primary efficacy and biomarker        X Le                        9556

ASCO Meeting Library, Wednesday, May 13 at 5 p.m.

analyses from the VISION study

of tepotinib in patients (pts)

with NSCLC with METex14 skipping

Bintrafusp Alfa

Poster Presentation

Two-year follow-up of                       L Paz-Ares

9558 ASCO Meeting Library, Wednesday, May 13 at 5 p.m.

bintrafusp alfa, a bifunctional

fusion protein targeting TGF-ß

and PD-L1, for second-line (2L)

treatment of non-small cell

lung cancer (NSCLC)

DDRi

Poster Presentation

A multicenter Phase Ib/II study         P Romesser

TPS4117                         ASCO Meeting Library, Wednesday, May 13 at 5 p.m.

of DNA-PK inhibitor peposertib

(formerly M3814) in combination

with capecitabine and radiotherapy

in patients with locally advanced

rectal cancer

About BAVENCIO® (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody.

BAVENCIO has been shown in preclinical models to engage both the adaptive and

innate immune functions. By blocking the interaction of PD-L1 with PD-1

receptors, BAVENCIO has been shown to release the suppression of the T

cell-mediated antitumor immune response in preclinical models.10-12 In November

2014, Merck and Pfizer announced a strategic alliance to co-develop and

co-commercialize BAVENCIO.

BAVENCIO Approved Indications

The European Commission has authorized the use of BAVENCIO in combination

with axitinib for the first-line treatment of adult patients with advanced

renal cell carcinoma (RCC). In September 2017, the European Commission granted

conditional marketing authorization for BAVENCIO as a monotherapy for the

treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

In the US, BAVENCIO in combination with axitinib is indicated for the

first-line treatment of patients with advanced renal cell carcinoma (RCC).

Additionally, the US Food and Drug Administration (FDA) granted accelerated

approval for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric

patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and

(ii) patients with locally advanced or metastatic urothelial carcinoma (mUC)

who have disease progression during or following platinum-containing

chemotherapy, or have disease progression within 12 months of neoadjuvant or

adjuvant treatment with platinum-containing chemotherapy. These indications are

approved under accelerated approval based on tumor response rate and duration

of response. Continued approval for these indications may be contingent upon

verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients with MCC in 50 countries

globally, with the majority of these approvals in a broad indication that is

not limited to a specific line of treatment.

BAVENCIO Safety Profile from the EU Summary of Product Characteristics

(SmPC)

The special warnings and precautions for use for BAVENCIO monotherapy

include infusion-related reactions, as well as immune-related adverse reactions

that include pneumonitis and hepatitis (including fatal cases), colitis,

pancreatitis (including fatal cases), myocarditis (including fatal cases),

endocrinopathies, nephritis and renal dysfunction, and other immune-related

adverse reactions. The special warnings and precautions for use for BAVENCIO in

combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO

monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea,

decreased appetite, constipation, infusion-related reactions, weight decreased

and vomiting. The list of most common adverse reactions with BAVENCIO in

combination with axitinib includes diarrhea, hypertension, fatigue, nausea,

dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and

arthralgia.

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.

All Merck Press Releases are distributed by e-mail at the same time they

become available on the Merck Website. Please go to

www.merckgroup.com/subscribe to register online, change your selection or

discontinue this service.

About Merck

Merck, a leading science and technology company, operates across

healthcare, life science and performance materials. Around 57,000 employees

work to make a positive difference to millions of people's 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 2019,

Merck generated sales of € 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to

Merck's technological and scientific advances. This is how Merck has thrived

since its founding in 1668. The founding family remains the majority owner of

the publicly listed company. Merck holds the global rights to the Merck name

and brand. The only exceptions are the United States and Canada, where the

business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma

in life science, and EMD Performance Materials.

Media contact:

julissa.viana@emdserono.com

Phone: +1-781-206-5795

Logo : https://mma.prnewswire.com/media/1136775/Merck_Logo.jpg

Source: Merck