Merck to Present Latest Highlights From Oncology Portfolio at WCLC and ESMO 2021

Merck, a leading science and technology company, today announced research from Company-sponsored, investigator-sponsored, and collaborative studies — including two oral and two mini-oral presentations — at this year’s World Conference on Lung Cancer, September 8-14, 2021, and the European Society for Medical Oncology (ESMO) Congress, September 16-21, 2021.

“Analyses presented from ongoing and completed trials at both of these meetings have the potential to make a difference for patients by meaningfully informing treatment decisions in challenging tumors such as lung and bladder cancers,” said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck.

Select presentations include:

BAVENCIO^® (avelumab)
Real-world evidence will be presented supporting the continued need for first-line treatments for advanced urothelial carcinoma. Data from an investigator-sponsored study of avelumab in combination with neoadjuvant chemotherapy to treat muscle-invasive bladder cancer will be presented for the first time. BAVENCIO has been approved in multiple countries as a first-line maintenance treatment of metastatic UC that has not progressed with first-line platinum containing chemotherapy based on a statistically significant overall survival benefit in a Phase III clinical study.

ESMO 2021
Title	Lead Author	Presentation #	Date/Time
Real-world study assessing physician rationale for initiating first-line (1L) immuno-oncology (IO) therapy for patients with aUC.	M. Ajmera	706P	Available on demand: Thursday, September 16 at 8:30am CEST.
Real-world (RW) treatment (Tx) patterns and clinical outcomes in patients (pts) with metastatic urothelial carcinoma (mUC) receiving first line (1L) Tx: results from IMPACT UC.	MA. Bilen	701P	Available on demand: Thursday, September 16 at 8:30am CEST.
Treatment pattern and overall survival among patients with locally advanced or metastatic urothelial carcinoma – Results from a complete nationwide unselected real-world registry study in Denmark from 2010 to 2017.	JB. Jensen	707P	Available on demand: Thursday, September 16 at 8:30am CEST.
Avelumab as the basis of neoadjuvant chemotherapy (NAC) regimen in platinum eligible and ineligible patients (pts) with non-metastatic muscle invasive bladder cancer (NM-MIBC).	NM. Chanza	659MO	Mini-oral session: Genitourinary tumours, non-prostate. Saturday, September 18, 6:12-6:17pm CEST. Channel 2.

Tepotinib
Data for oral MET inhibitor tepotinib at IASLC 2021 World Conference on Lung Cancer (WCLC 2021) and ESMO include:

• Data from the VISION trial — the largest study of patients with METex14 skipping NSCLC prospectively enrolled based on liquid and/or tissue biopsy (n=275)
  • New results demonstrating robust and durable efficacy, and manageable safety
  • First-time results in key age subgroups including patients >75 years.
• A trial-in-progress update from the ongoing INSIGHT 2 study in EGFR-mutant NSCLC with MET amplification.

ESMO 2021
Title	Lead Author	Presentation #	Date/Time
Efficacy and safety of tepotinib in patients with advanced age: VISION subgroup analysis of patients with MET exon 14 (METex14) skipping NSCLC.	MC. Garassino	1254P	Available on demand: Thursday, September 16 at 8:30am CEST.
Tepotinib plus osimertinib for EGFR-mutant NSCLC with resistance to first-line osimertinib due to MET amplification: INSIGHT 2.	Y-L. Wu	1366TIP	Available on demand: Thursday, September 16 at 8:30am CEST.
Health utility with tepotinib in patients (pts) with MET exon 14 (METex14) skipping non-small cell lung cancer (NSCLC).	N. Reinmuth	1255P	Available on demand: Thursday, September 16 at 8:30am CEST.
WCLC 2021
Title		Lead Author	Presentation #
Tepotinib in patients with MET exon 14 (METex14) skipping NSCLC as identified by liquid (LBx) or tissue (TBx) biopsy.		E. Felip	P45.03
Tepotinib plus an EGFR TKI in patients with EGFR-mutant NSCLC and resistance to EGFR TKIs due to MET amplification (METamp).		C-K. Liam	P51.01

Berzosertib (M6620)
For the leading asset in the Company’s DDR inhibitor program, a first-time look at the ongoing Phase II study of ATR inhibitor berzosertib in patients with relapsed platinum-resistant small cell lung cancer (SCLC) will be presented.

ESMO 2021
Title	Lead Author	Presentation	Date/Time
Phase 2 study of berzosertib (M6620) + topotecan in patients with relapsed platinum-resistant SCLC: DDRiver SCLC 250.	A. Thomas	1666TIP	Available on demand: Thursday, September 16 at 8:30am CEST.

ERBITUX^® (cetuximab)
ERBITUX continues to demonstrate, in a number of studies, its significant role as the backbone of treatment in metastatic colorectal cancer.

ESMO 2021
Title	Lead Author	Presentation #		Date/Time
Comparison of cetuximab every 2 weeks versus standard once-weekly administration for the first-line treatment of RAS wild-type mCRC among patients with left- and right-sided primary tumor location.	S. Kasper	415P	Available on demand: Thursday, September 16 at 8:30am CEST.
Tumour mutation profiles and circulating tumour cells in metastatic colorectal cancer patients treated with FOLFIRI + cetuximab. A prospective ancillary study of the UNICANCER PRODIGE-28 trial.	H. Blons	387MO	Mini-oral session: Gastrointestinal tumours, colorectal. Saturday, September 18, 5:35-5:40pm CEST. Channel 4.

Bintrafusp Alfa (M7824)

ESMO 2021
Title	Lead Author	Presentation #		Date/Time
Long-term follow-up of patients with human papillomavirus (HPV)-associated malignancies treated with bintrafusp alfa, a bi-functional fusion protein targeting TGF-β and PD-L1.	J. Strauss	957O	Proffered paper session: Investigational immunotherapy. Friday, September 17, 1:40-1:50pm CEST. Channel 4.
Adverse event management during treatment with bintrafusp alfa, a bifunctional fusion protein targeting TFG-β and PD-L1: treatment guidance based on experience in clinical trials.	J. Gulley	1689P	Available on demand: Thursday, September 16 at 8:30am CEST.

Merck is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer. Our oncology research efforts aim to leverage our synergistic portfolio in oncogenic pathways, immuno-oncology, and DNA Damage Response (DDR) to tackle challenging tumor types in gastrointestinal, genitourinary, and thoracic cancers. Our curiosity drives our pursuit of treatments for even the most complex cancers, as we work to illuminate a path to scientific breakthroughs that transform patient outcomes. Learn more at https://www.merckgrouponcology.com.

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. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications
The European Commission (EC) has authorized the use of BAVENCIO as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized by the EC for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

In the US, BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC 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.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced RCC. Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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

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 Tepotinib
Tepotinib is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck, tepotinib has a highly selective mechanism of action, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.

Tepotinib was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring MET gene alterations, with its approval in Japan in March 2020 under the brand name TEPMETKO ^® . Tepotinib was approved in the United States in February 2021 for the treatment of adult patients with metastatic NSCLC harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations under the brand name TEPMETKO^®. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Tepotinib is currently under regulatory review by the European Medicines Agency (EMA).

About Berzosertib
Berzosertib is an investigational, potent and selective inhibitor of the ataxia telangiectasia and Rad3-related (ATR) protein that blocks ATR activity in cells. Berzosertib is the first ATR inhibitor evaluated in a randomized clinical trial in any tumor type, and it is the lead candidate in Merck’s DNA Damage Response (DDR) inhibitor portfolio. It is currently being investigated in a number of internal and external studies with early phase I/II data in small cell lung cancer, ovarian cancer, and various solid tumors. Berzosertib, formerly known as VX-970, was licensed from Vertex Pharmaceuticals in 2017. Berzosertib is not approved for any use anywhere in the world.

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.

About Bintrafusp Alfa
Bintrafusp alfa (M7824), discovered in-house at Merck, is currently in clinical development through a strategic alliance with GSK.

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About Merck
Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 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 2020, Merck generated sales of € 17.5 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 Electronics.

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