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30.04.2020 – 14:00

Merck KGaA

Data From Merck at ASCO 2020 to Showcase Significant Clinical Advances in Cancer Care

Darmstadt, Germany and New YorkDarmstadt, Germany and New York (ots/PRNewswire)

- 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-?/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-?/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
 best supportive care (Ave                                Session, Sunday, May
 + BSC) vs BSC alone after                                31 at 1 p.m.Abstract
 platinum-based first-line                                available online at
 (1L) chemotherapy (CTx) in                               the ASCO Meeting
 advanced urothelial                                      Library from
 carcinoma (aUC): results                                 Thursday, May 28 at 5
 from the JAVELIN Bladder                                 p.m.
 100 phase 3 trial

 Poster Presentation

 Association of neutrophil  MA Bilen       5061           ASCO Meeting Library,
 to lymphocyte ratio (NLR)                                Wednesday, May 13 at
 with efficacy from JAVELIN                               5 p.m.
 Renal 101

 Tepotinib

 Poster Presentation

 Tepotinib in patients      PK Paik        9575           ASCO Meeting Library,
 (pts) with NSCLC with MET                                Wednesday, May 13 at
 exon 14 ( MET ex14)                                      5 p.m.
 skipping: health-related
 quality of life (HRQoL)
 (VISION PRO)

 Primary efficacy and       X Le           9556           ASCO Meeting Library,
 biomarker analyses from                                  Wednesday, May 13 at
 the VISION study of                                      5 p.m.
 tepotinib in patients
 (pts) with NSCLC with MET
 ex14 skipping

 Bintrafusp Alfa

 Poster Presentation

 Two-year follow-up of      L Paz-Ares     9558           ASCO Meeting Library,
 bintrafusp alfa, a                                       Wednesday, May 13 at
 bifunctional fusion                                      5 p.m.
 protein targeting TGF-?
 and PD-L1, for second-line
 (2L) treatment of
 non-small cell lung cancer
 (NSCLC)

 DDRi

 Poster Presentation

 A multicenter Phase Ib/II  P Romesser     TPS4117        ASCO Meeting Library,
 study of DNA-PK inhibitor                                Wednesday, May 13 at
 peposertib (formerly                                     5 p.m.
 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.

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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 EUR 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.

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