Merck to Present Latest Research from Oncology Portfolio at ESMO 2023

Merck, a leading science and technology company, today announced that 28 abstracts featuring the latest research on the company’s oncology portfolio addressing unmet needs across bladder, head and neck, lung, colorectal and other cancers, will be presented at the 2023 European Society of Medical Oncology (ESMO) Annual Meeting, October 20-24, Madrid, Spain.

Presentations at the meeting encompass new analyses for the standard-of-care medicines BAVENCIO^® (avelumab), TEPMETKO^® (tepotinib) and ERBITUX^® (cetuximab). Additional presentations and activities at ESMO highlight the company’s efforts to improve the lives of people with cancer. Key presentations include:

BAVENCIO

Based on the results of the randomized Phase III JAVELIN Bladder 100 study, the first-line maintenance regimen of BAVENCIO plus best supportive care has become a guideline-recommended standard of care in the locally advanced and metastatic urothelial carcinoma (UC) treatment setting. Previously presented long-term follow-up results have demonstrated median overall survival (OS) from start of chemotherapy of 29.7 months among patients receiving BAVENCIO who had not progressed on first-line platinum-based chemotherapy, establishing a new reference point for treatment outcomes in clinical studies. New analyses and real-world evidence to be presented at ESMO reinforce the role of the JAVELIN Bladder regimen in this setting.

• Long-term efficacy and safety outcomes from JAVELIN Bladder 100 confirm the prolonged OS, progression-free survival, and tolerability of first-line maintenance with BAVENCIO in patients older than 65 years with advanced UC.
• Further evidence from France and the United States, including first-time data in patients with advanced UC with histological variants in the French AVENANCE study, support the findings of JAVELIN Bladder 100 in real-world settings.

Additional real-world analyses reinforce the use of BAVENCIO as a treatment for advanced/metastatic Merkel cell carcinoma (MCC), a rare form of skin cancer. After a median follow-up of ~29 months, data from the MCC TRIM study showed a median OS of 52 months for patients with metastatic MCC treated with BAVENCIO in a real-world setting in Germany. Most patients (~86%) received first-line BAVENCIO. BAVENCIO was the first cancer immunotherapy to receive accelerated approval from the US Food and Drug Administration (FDA) in March 2017 for the treatment of metastatic MCC; the approval was based on the results of the multicenter, international, single-arm, open-label, Phase II JAVELIN Merkel 200 trial. In September 2023, the accelerated approval in the US was converted into full approval for use of BAVENCIO for the treatment of metastatic MCC.

TEPMETKO

TEPMETKO is the first oral MET inhibitor to have received a regulatory approval anywhere in the world for the treatment of advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations, with its approval in Japan in March 2020. Updated findings from the Phase II VISION trial, which is the largest study of a MET inhibitor in this setting and served as the basis for regulatory approvals, continue to show clinically meaningful long-term efficacy in patients with METex14-skipping NSCLC treated with TEPMETKO regardless of line of therapy (2L, 2L+ and 3L+).

Head and Neck Cancer

Aligned with the company’s commitment to addressing the unmet needs of patients with squamous cell carcinoma of the head and neck (SCCHN), a new analysis of real-world survival outcomes and survival risk factors in elderly patients with locally advanced (LA) disease will be presented. Findings highlight poor survival outcomes, especially in patients aged 70 years and older with advanced disease stage and comorbidities, underscoring the need for innovative effective treatments for this population.

The company is investigating the IAP (inhibitor of apoptosis protein) inhibitor xevinapant (formerly known as Debio 1143) in two ongoing Phase III clinical trials in patients with LA SCCHN. The first is the international, randomized, double-blind, placebo-controlled TrilynX study (NCT04459715) to evaluate the efficacy and safety of xevinapant versus placebo when added to definitive chemoradiotherapy in patients with unresected LA SCCHN. The second is XRay Vision (NCT05386550), an international randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of xevinapant versus placebo when added to adjuvant, post-operative radiotherapy in patients with resected LA SCCHN who are at high risk for relapse and are ineligible for cisplatin.

Additional company-sponsored activity at ESMO:

Medical Symposia

• Putting Patients First: Cultivating Care in Bladder Cancer.Chair: Joaquim Bellmunt, USA. Saturday, 21 October 2023, 13:00-14:30, Toledo Auditorium
• Exploring SCCHN: Insight Into an Evolving Treatment Landscape.Chair: Hisham Mehanna, UK. Saturday, 21 October 2023, 18:30-20:00, Oviedo Auditorium

Evening Lecture

• Beyond biomarkers: Navigating patient selection in mCRC. Sunday, 22 October 2023, 19:45-22:00, Espacio La Salle, C. de San Juan de la Salle, 4

Additionally, the company will feature its educational initiative for oncology professionals on the unmet medical need in LA SCCHN, cancer’s resistance to apoptosis, and the role of apoptosis proteins. More information can be found at www.TheWallinSCCHN.com or at Booth #526.

Select Merck-related abstracts accepted for presentation at ESMO 2023 include (all times in CEST):

Title	Lead Author	Abstract	Session Information
BAVENCIO (avelumab)
Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): long-term outcomes from the JAVELIN Bladder 100 trial in older patients (pts)	S Gupta	2371P	Session Title: Urothelial cancer Date: 23.10.2023 Session: 09:00-17:00 Presentation: 12:00-13:00
AVENANCE: subgroup analysis of patients (pts) with advanced urothelial carcinoma (aUC) with histological variants from a real-world (RW) study of avelumab first-line maintenance (1LM)	P Barthelemy	2379P	Session Title: Urothelial cancer Date: 23.10.2023 Session: 09:00-17:00 Presentation: 12:00-13:00
Clinical characteristics and survival of patients with advanced Merkel cell carcinoma (MCC) treated with avelumab: analysis of a prospective German MCC registry (MCC TRIM)	JC Becker	1145P	Session Title: Melanoma and other skin tumours Dat: 22.10.2023 Session: 09:00-17:00 Presentation: 12:00-13:00
Xevinapant
Real-world survival outcomes and survival risk factors in elderly patients with locally advanced squamous cell carcinoma of the head and neck	L Ember	890P	Session: Head and neck cancer, excl. thyroid Date: 22.10.2023 Session: 09:00-17:00 Presentation: 12:00-13:00
TEPMETKO (tepotinib)
Treatment (Tx) sequencing with tepotinib in previously treated patients (pts) with MET exon 14 (METex14) skipping NSCLC in the VISION trial	S Viteri	1380P	Session Title: NSCLC, metastatic Date: 23.10.2023 Session: 09:00-17:00 Presentation: 12:00-13:00
Liquid biopsies (LBx) and tissue biopsies (TBx) for identifying MET exon 14 (METex14) skipping in advanced NSCLC: Analyses from the Phase II VISION study of Tepotinib	C Rolfo	1382P	Session Title: NSCLC, metastatic Date: 23.10.2023 Session: 09:00-17:00 Presentation: 12:00-13:00
ERBITUX (cetuximab)
Modified (m)-FOLFOXIRI plus cetuximb treatment and predictive clinical factors for RAS/BRAF wild-type and left-sided metastatic colorectal cancer (mCRC): the DEEPER trial (JACCRO CC-13)	Y Sunakawa	550MO	Mini Oral Session: Gastrointestinal tumours, lower digestive Date: 22.10.2023 Session: 14:45-16:15 Presentation: 14:55

Advancing the Future of Cancer Care

At Merck, we strive every day to improve the futures of people living with cancer. Our research explores the full potential of promising mechanisms in cancer research, focused on synergistic approaches designed to hit cancer at its core. We are determined to maximize the impact of our standard-of-care treatments and to continue pioneering novel medicines. Our vision is to create a world where more cancer patients will become cancer survivors. Learn more at 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.

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) has approved BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC.

BAVENCIO is currently approved for at least one indication for patients in more than 50 countries.

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 TEPMETKO^® (tepotinib)

TEPMETKO is a once-daily oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck, TEPMETKO 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.

TEPMETKO is the first oral MET inhibitor to have received a regulatory approval anywhere in the world for the treatment of advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations, with its approval in Japan in March 2020. In February 2021, the US Food and Drug Administration granted accelerated approval to TEPMETKO, making it the first and only once-daily oral MET inhibitor approved for patients in the US with metastatic NSCLC with METex14-skipping alterations. In February 2022, the European Commission (EC) approved once-daily oral TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

TEPMETKO is available in a number of countries. To meet an urgent clinical need, TEPMETKO is also available in a pilot zone of China in line with the government policy to drive early access for innovative medicines approved outside of China.

Merck is also investigating the potential role of tepotinib in treating patients with NSCLC and acquired resistance due to MET amplification in the Phase II INSIGHT 2 study of tepotinib in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib.

TEPMETKO Safety Profile from the EU Summary of Product Characteristics (SmPC)

The special warnings and precautions for use for TEPMETKO monotherapy include Interstitial lung disease (ILD) or ILD-like adverse reactions including pneumonitis, increase of liver enzymes (ALT and AST), QTc prolongation, and embryo-fetal toxicity.

The most common adverse reactions in ≥ 20% of exposed to tepotinib at the recommended dose in the target indication are oedema, mainly peripheral oedema, nausea, hypoalbuminemia, diarrhea and increase in creatinine. The most common serious adverse reactions in ≥ 1% of patients are peripheral oedema, generalized oedema and ILD.

About Xevinapant

Xevinapant (formerly known as Debio 1143) is an investigational first-in-class potent oral small-molecule IAP (inhibitor of apoptosis protein) inhibitor for the treatment of LA SCCHN. In preclinical studies, xevinapant restored sensitivity to apoptosis in cancer cells, thereby enhancing the effects of chemotherapy and radiotherapy. Xevinapant, the most clinically advanced IAP inhibitor, improved efficacy outcomes in combination with chemoradiotherapy (CRT), including three-year progression-free survival and five-year survival, compared with placebo plus CRT in a Phase II study in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). In March 2021, Merck gained exclusive rights from Debiopharm to develop and commercialize xevinapant worldwide. Xevinapant 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.

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About Merck

Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 64,000 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 providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck generated sales of € 22.2 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 MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

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