Merck Highlights Commitment to Improving Cancer Outcomes at ASCO 2023

Merck, a leading science and technology company, today announced that 43 abstracts covering several modalities and mechanisms will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-6, Chicago, Ill., US. New data for the medicines BAVENCIO^® (avelumab), ERBITUX^® (cetuximab), and TEPMETKO^® (tepotinib) and pipeline assets including the first-in-class investigational IAP (inhibitor of apoptosis protein) inhibitor xevinapant demonstrate the Company’s efforts to pioneer novel medicines intended to improve the lives of people living with cancer.

“The research we will present at ASCO 2023 demonstrates that we are not only maximizing the impact of our standard-of-care treatments but also advancing development programs focused on synergistic approaches targeting key cancer pathways and mechanisms,” said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck.

Key presentations include:

• BAVENCIO (Abstracts: 4515, 4516) clinical data reinforce its role as a standard of care in first-line maintenance for advanced urothelial carcinoma (UC): Poster discussions, including long-term safety analyses and an analysis of quality-adjusted survival from the Phase III JAVELIN Bladder 100 study, confirm the acceptable long-term benefit-risk profile as well as the net benefit estimate of BAVENCIO first-line (1L) maintenance and further support its use as a standard of care for advanced UC. As part of the JAVELIN Bladder regimen, BAVENCIO first-line maintenance has demonstrated the longest survival benefit seen to date in a global, randomized Phase III trial in advanced UC.
  

• Xevinapant (Abstracts: TPS6101, 6027) preclinical data supporting dosing rationale for this investigational IAP inhibitor as well as a trial-in-progress poster outlining design of the recently initiated Phase III XRay Vision^® study in locally advanced squamous cell carcinoma of the head and neck (LA SCCHN): Preclinical data demonstrate the benefit of extended xevinapant treatment beyond the completion of xevinapant plus radiotherapy (RT) and support the rationale for administration of six cycles of xevinapant in the ongoing Phase III studies, while also indicating that restoring sensitivity to apoptosis may address some unmet treatment needs in LA SCCHN. The trial design of the ongoing randomized Phase III XRay Vision study also will be featured. This study is assessing xevinapant plus RT in patients with resected, high-risk LA SCCHN who are not eligible for cisplatin.
  

• TEPMETKO (Abstracts: 9021, 9060, 9070, 9074) data continue to demonstrate durable efficacy for first-line treatment of METex14 advanced non-small cell lung cancer (NSCLC): Long-term outcomes from the VISION study, the largest study of a MET inhibitor in patients with METex14-skipping advanced NSCLC (N=313), demonstrate the robust and durable clinical activity of TEPMETKO, particularly in the first-line setting, detected by liquid and/or tissue biopsy: with median follow-up of 32.6 months, in 164 first-line patients, overall response rate was 57.3% (95% CI: 49.4, 65.0) and median duration of response was 46.4 months (13.8, not estimable). A manageable safety profile further supports its use in clinical practice. Additional presentations for TEPMETKO include analyses from the INSIGHT 2 study in EGFRm METamp NSCLC for patients treated with TEPMETKO plus osimertinib.
  

• ERBITUX (Abstracts: 3507, 3544, 3603) data to be presented at the congress add to the growing body of evidence supporting the role of cetuximab-based therapies across the continuum of care in the treatment of RAS wild-type metastatic colorectal cancer and as a backbone of treatment in SCCHN.

Additional company-sponsored activity at ASCO:

• CME Live Symposium & Webcast, “After More Than a Decade: Can We Now Enhance Treatment of Patients With LA SCCHN?” with course director Kevin Harrington, PhD, FRCR, FRCP, The Institute of Cancer Research, The Royal Marsden Hospital, London, UK, on June 3, 7:00-8:00 PM CDT, Hilton Chicago (720 South Michigan Ave.), room Continental A.
• A UC Biosphere™ Connect event, “First-Line Maintenance Therapy: Supporting Patient Care in aUC” on June 4, 6:30-8:00 PM CDT, Marriott Marquis Chicago (connected to McCormick Place, 2121 S. Prairie Ave.), Great Lakes Ballroom C, Level 2)

In addition to the data being presented at ASCO 2023, Merck will launch a new 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 on the initiative can be found at www.TheWallinSCCHN.com.

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

Title	Lead Author	Abstract		Session Information
BAVENCIO (avelumab)
Advanced Urothelial Carcinoma
Long-term safety of avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC) in the JAVELIN Bladder 100 trial	Bellmunt J	4516		Genitourinary Cancer: Kidney and Bladder Saturday, June 3, 2023 8:00AM-11:00AM Poster Discussion Time: 3:00PM-4:30PM
Estimated net benefit of avelumab (AVE) + best supportive care (BSC) vs BSC alone for patients (pts) with advanced urothelial carcinoma (aUC) using a quality-adjusted time without cancer symptoms or toxicity (Q-TWiST) analysis	Powles T	4515		Genitourinary Cancer: Kidney and Bladder Saturday, June 3, 2023 8:00AM-11:00AM Poster Discussion Time: 3:00PM-4:30PM
Real-world response (rwR) rates and clinical outcomes of patients treated with first-line (1L) platinum-based chemotherapy (PBC) for advanced urothelial cancer (aUC)	Moon HH	4567	Genitourinary Cancer: Kidney and Bladder Saturday, June 3, 2023 8:00 AM-11:00 AM
Metastatic Merkel Cell Carcinoma
Avelumab as second-line or later (2L+) treatment in patients (pts) with metastatic Merkel cell carcinoma (mMCC): analysis of real-world outcomes in France using the CARADERM registry and the French national healthcare database	Blom A	9537		Melanoma/Skin Cancers Saturday, June 3, 2023 1:15PM-4:15PM
Metastatic Colorectal Cancer
Modified FOLFOXIRI plus cetuximab and avelumab as initial therapy in RAS wild-type unresectable metastatic colorectal cancer: results of the phase II AVETRIC trial by GONO	Conca V	3575		Gastrointestinal Cancer: Colorectal and Anal Monday, June 5, 2023 8:00AM-11:00AM
Xevinapant
Phase 3 study of xevinapant plus radiotherapy (RT) for high-risk, cisplatin-ineligible patients with resected, locally advanced squamous cell carcinoma of the head and neck (LA SCCHN)	Ferris RL	TPS6101		Head and Neck Cancer Monday, June 5, 2023 1:15PM-4:15PM
Effect of extended treatment with IAP inhibitor xevinapant post radiotherapy (RT) on efficacy and the tumor microenvironment (TME) in preclinical models	Yeung TL	6027		Head and Neck Cancer Monday, June 5, 2023 1:15PM-4:15PM
TEPMETKO (tepotinib)
Long-term outcomes of tepotinib in patients with MET exon 14 skipping NSCLC from the VISION study	Paik P	9060		Lung Cancer: Non-Small Cell Metastatic Sunday, June 4, 2023 8:00AM-11:00AM
Tepotinib + osimertinib for EGFR mutant (EGFRm) NSCLC with MET amplification (METamp) after first-line (1L) osimertinib	Tan D	9021		Lung Cancer: Non-Small Cell Metastatic Sunday, June 4, 2023 8:00AM-11:00AM Poster Discussion Time: 4:30PM-6:00PM
Detection of MET amplification (METamp) in patients with EGFR mutant (m) NSCLC after first-line (1L) osimertinib	Yu H	9074		Lung Cancer: Non-Small Cell Metastatic Sunday, June 4, 2023 8:00AM-11:00AM
Patients with EGFR-mutant (m) MET-altered NSCLC receiving tepotinib with an EGFR tyrosine kinase inhibitor (TKI): a case series	Le X	9070		Lung Cancer: Non-Small Cell Metastatic Sunday, June 4, 2023 8:00 AM-11:00 AM
ERBITUX (cetuximab)
Phase III FIRE-4 study (AIO KRK-0114): Influence of Baseline Liquid Biopsy results in first-line treatment efficacy of FOLFIRI/cetuximab in patients with tissue RAS-WT mCRC	Stintzing S	3507		Oral Abstract Session Gastrointestinal Cancer: Colorectal and Anal Sunday, June 4, 2023 8:00AM-11:00AM
Early tumor shrinkage (ETS) as clinical factor to select maintenance with cetuximab (cet) alone in RAS/BRAF wild-type (wt) metastatic colorectal cancer (mCRC) patients (pts): a secondary endpoint analysis of the ERMES study	Orlandi A	3603		Gastrointestinal Cancer: Colorectal and Anal Monday, June 5, 2023 8:00AM-11:00AM
Prognostic role of TP53 variants in the phase III study of FOLFIRI/cetuximab versus FOLFIRI/cetuximab followed by cetuximab (Cet) alone in first-line therapy of RAS and BRAF wild-type (wt) metastatic colorectal cancer (mCRC) patients (ERMES study)	Normanno N	3544		Gastrointestinal Cancer: Colorectal and Anal Monday, June 5, 2023 8:00AM-11:00AM

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. The Merck-Pfizer strategic alliance regarding BAVENCIO was mutually terminated, with an effective date of June 30, 2023, with Merck regaining exclusive worldwide rights for 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 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 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. 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 non-small cell lung cancer (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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