Merck to Present New Data at ESMO 2022 Congress From Its Broad Oncology Portfolio and Promising Pipeline, Demonstrating Commitment to Improving Long-Term Survival in Multiple Types of Cancer

Longer-term survival results underscoring role of KEYTRUDA^® (pembrolizumab) in multiple cancer types, including advanced nonsquamous non-small cell lung cancer (KEYNOTE-189)

Seven-year survival from SOLO-1 and final overall survival (OS) results from PAOLA-1 highlight role of LYNPARZA^® (olaparib) in first-line maintenance of advanced ovarian cancer

First presentation of KEYTRUDA in combination with an antibody-drug conjugate (enfortumab vedotin) (Phase 1b/2 EV-103/KEYNOTE-869 Cohort K)

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that research spanning 16 different cancer types will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris, France from Sept. 9-13. The breadth of data showcases the continued impact of Merck’s portfolio of oncology medicines and the potential of Merck’s innovative oncology pipeline.

“We are proud to present longer-term survival data in patients with lung, ovarian, melanoma and head and neck cancers, as well as findings that reinforce the impact of our medicines in earlier stages of certain cancers and in new combinations,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Notably, we look forward to sharing five-year survival results from the pivotal KEYNOTE-189 study that has established the foundational role of KEYTRUDA in the first-line treatment setting for patients with metastatic nonsquamous non-small cell lung cancer, and results from EV-103/KEYNOTE-869, a study of KEYTRUDA in combination with the antibody-drug conjugate, enfortumab vedotin, in patients with locally advanced or metastatic urothelial cancer.”

Presentations will feature new or updated findings from Merck’s growing pipeline and broad portfolio of cancer medicines: KEYTRUDA; WELIREG™ (belzutifan); LYNPARZA (in collaboration with AstraZeneca); LENVIMA^® (lenvatinib, in collaboration with Eisai); and ODM‑208, an investigational steroid synthesis inhibitor (in collaboration with Orion).

Key Merck and collaborative data at ESMO 2022:

• Five-year overall survival (OS) data from the pivotal Phase 3 KEYNOTE-189 and KEYNOTE-407 trials evaluating KEYTRUDA in combination with chemotherapy as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) (Presentations #973MO and #974MO, respectively);
• Seven-year OS data from the Phase 3 SOLO-1 trial evaluating maintenance LYNPARZA in patients with advanced BRCA-mutated ovarian cancer, following first-line platinum-based chemotherapy (Presentation #517O) and final OS results from the Phase 3 PAOLA-1 trial evaluating maintenance LYNPARZA in combination with bevacizumab in patients with advanced ovarian cancer following first-line platinum-based chemotherapy and bevacizumab (Presentation #LBA29);
• First-time data from Cohort K of the Phase 1b/2 EV-103/KEYNOTE-869 trial evaluating PADCEV^® (enfortumab vedotin) in combination with KEYTRUDA as first-line treatment for patients with cisplatin-ineligible unresectable locally advanced or metastatic urothelial cancer (Presentation #LBA73), which reported positive topline results for the primary endpoint of objective response rate earlier this year;
• First-time data from NCI-sponsored SWOG S1801, a Phase 2 study of neoadjuvant versus adjuvant KEYTRUDA for clinically detectable and resectable stage III to IV melanoma, to be featured in Presidential Symposium II (Presentation #LBA6).

Merck presentations at ESMO 2022:

Abstract title	Details
Breast cancer
HRQoL With Neoadjuvant Pembrolizumab + Chemotherapy Vs Placebo + Chemotherapy, Followed By Adjuvant Pembrolizumab Vs Placebo For Early-Stage TNBC: Results From KEYNOTE-522. R. Dent.	Presentation #135MO, Mini Oral

Gastrointestinal cancers
Additional Analyses Of MOUNTAINEER: A Phase 2 Study Of Tucatinib And Trastuzumab For HER2-Positive mCRC. J. Strickler.	Presentation #LBA27, Mini Oral
Tucatinib Plus Trastuzumab In Patients (Pts) With HER2-Positive Metastatic Colorectal Cancer (mCRC): Patient-Reported Outcomes (PROs) From Ph 2 Study MOUNTAINEER. C. Wu.	Presentation #361P, Poster
Extended Overall Survival Results From The POLO Study Of Active Maintenance Olaparib In Patients With Metastatic Pancreatic Cancer And A Germline BRCA Mutation. P. Hammel.	Presentation #1298P, Poster

Genitourinary cancers
Belzutifan, A Hypoxia-Inducible Factor-2α Inhibitor, For Von Hippel-Lindau (VHL) Disease-Associated Neoplasms: 36 Months Of Follow-Up Of The Phase 2 LITESPARK-004 Study. R. Srinivasan.	Presentation #LBA69, Mini Oral
Study EV-103 Cohort K: Antitumor Activity Of Enfortumab Vedotin (EV) Monotherapy Or In Combination With Pembrolizumab (P) In Previously Untreated Cisplatin-Ineligible Patients (Pts) With Locally Advanced Or Metastatic Urothelial Cancer (la/mUC). J. Rosenberg.	Presentation #LBA73, Proffered Paper
Proffered Paper: Biomarker Analysis And Updated Results From The Phase 3 PROpel Trial Of Abiraterone (Abi) And Olaparib (Ola) Vs Abi And Placebo (Pbo) As First-Line (1L) Therapy For Patients (Pts) With Metastatic Castration-Resistant Prostate Cancer (mCRPC). F. Saad.	Presentation #1357O, Proffered Paper
Pembrolizumab + Olaparib Vs Abiraterone (Abi) Or Enzalutamide (Enza) For Patients (Pts) With Previously Treated Metastatic Castration-Resistant Prostate Cancer (mCRPC): Randomized Open-Label Phase 3 KEYLYNK-010 Study. E. Yu.	Presentation #1362MO, Mini Oral
Preliminary Phase 2 Results Of The CYPIDES Study Of ODM-208 In Metastatic Castration-Resistant Prostate (mCRPC) Cancer Patients. K. Fizazi.	Presentation #1364MO, Mini Oral
Two-Year Follow-Up Of KEYNOTE-365 Cohort D: Pembrolizumab (Pembro) Plus Abiraterone Acetate (Abi) And Prednisone In Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer (mCRPC). M. Linch.	Presentation #1389P, Poster
Phase 2 Study Of Belzutifan Plus Cabozantinib As First-Line Treatment Of Advanced Renal Cell Carcinoma (RCC): Cohort 1 Of LITESPARK-003. T. Choueiri.	Presentation #1447O, Proffered Paper
Phase 2 KEYNOTE-B61 Study Of Pembrolizumab (Pembro) + Lenvatinib (Lenva) As First-Line Treatment For Non-Clear Cell Renal Cell Carcinoma (nccRCC). L. Albiges.	Presentation #1448O, Proffered Paper
Updated Efficacy of Lenvatinib (LEN) + Pembrolizumab (PEMBRO) Vs Sunitinib (SUN) In Patients (Pts) With Advanced Renal Cell Carcinoma (aRCC) In The CLEAR Study. C. Guglielmo.	Presentation #1449MO, Mini Oral
Phase 2 Study of Belzutifan Plus Cabozantinib For Previously Treated Advanced Renal Cell Carcinoma (RCC): Update From Cohort 2 Of LITESPARK-003. D. McDermott.	Presentation #1453P, Poster

Gynecologic cancers
Final Overall Survival (OS) Results From The Phase III PAOLA-1/ENGOT-ov25 Trial Evaluating Maintenance Olaparib (Ola) Plus Bevacizumab (Bev) In Patients (Pts) With Newly Diagnosed Advanced Ovarian Cancer (AOC). I. Ray-Coquard.	Presentation #LBA29, Proffered Paper
Overall Survival (OS) At 7-Year (y) Follow-up (F/u) In Patients (Pts) With Newly Diagnosed Advanced Ovarian Cancer (OC) And A BRCA Mutation (BRCAm) Who Received Maintenance Olaparib In The SOLO1/GOG-3004 Trial. P. DiSilvestro.	Presentation #517O, Proffered Paper
Updated Efficacy and Safety Of Lenvatinib (LEN) + Pembrolizumab (Pembro) Vs Treatment Of Physician’s Choice (TPC) In Patients (Pts) With Advanced Endometrial Cancer (aEC): Study 309/KEYNOTE-775. V. Makker.	Presentation #525MO, Mini Oral
Pembrolizumab For Microsatellite Instability-High (MSI-H) Or Mismatch Repair Deficient (dMMR) Advanced Endometrial Cancer: Long-Term Follow-Up Results From KEYNOTE-158. D. O’Malley.	Presentation #546P, Poster

Head and neck cancer
Primary Results Of The Phase 3 KEYNOTE-412 Study: Pembrolizumab (Pembro) With Chemoradiation (CRT) Vs Placebo Plus CRT For Locally Advanced (LA) Head And Neck Squamous Cell Carcinoma (HNSCC). J. Machiels.	Presentation #LBA5, Proffered Paper
Pembrolizumab (Pembro) + Carboplatin (Carbo) + Paclitaxel (Pacli) As First-Line (1L) Therapy In Recurrent/Metastatic (R/M) Head And Neck Squamous Cell Carcinoma (HNSCC): Phase 4 KEYNOTE-B10 Study. M. Dzienis.	Presentation #651O, Proffered Paper
Pembrolizumab (Pembro) Vs Standard-Of-Care (SOC) In Previously Treated Recurrent/Metastatic (R/M) Head And Neck Squamous Cell Carcinoma (HNSCC): 6-Year Follow-Up Of KEYNOTE-040. D. Soulieres.	Presentation #658MO, Mini Oral
Pembrolizumab With Or Without Chemotherapy For First-Line Treatment Of Recurrent/Metastatic (R/M) Head And Neck Squamous Cell Carcinoma (HNSCC): 5-Year Results From KEYNOTE-048. M. Tahara.	Presentation #659MO, Mini Oral

Liver cancer
Primary Results From The Phase 3 LEAP-002 Study: Lenvatinib Plus Pembrolizumab Versus Lenvatinib As First-Line Therapy For Advanced Hepatocellular Carcinoma (HCC). R. Finn.	Presentation #LBA34, Proffered Paper
Pembrolizumab (Pembro) Vs Placebo (Pbo) As Second-Line Treatment For Sorafenib-Treated Advanced Hepatocellular Carcinoma (aHCC): 4.5-Year Follow-Up From KEYNOTE-240. J. Edeline.	Presentation #713P, Poster

Lung cancer
PD-L1 Expression and Outcomes Of Pembrolizumab And Placebo In Completely Resected Stage IB-IIIA NSCLC: Subgroup Analysis Of PEARLS/KEYNOTE-091. S. Peters.	Presentation #930MO, Mini Oral
KEYNOTE-189 5-Year Update: First-Line Pembrolizumab (Pembro) + Pemetrexed (Pem) And Platinum Vs Placebo (Pbo) + Pem And Platinum For Metastatic Nonsquamous NSCLC. M. Garassino.	Presentation #973MO, Mini Oral
5-Year Update From KEYNOTE-407: Pembrolizumab Plus Chemotherapy In Squamous Non‒Small-Cell Lung Cancer (NSCLC). S. Novello.	Presentation #974MO, Mini Oral

Skin cancer
Neoadjuvant Versus Adjuvant Pembrolizumab For Resected Stage III-IV Melanoma (SWOG S1801). S. Patel.	Presentation #LBA6, Proffered Paper
Pembrolizumab Versus Placebo After Complete Resection Of High-Risk Stage III Melanoma: Long-Term Quality Of Life Analysis Results Of The EORTC 1325-MG/KEYNOTE-054 Double-Blinded Phase 3 Trial. A. Bottomley.	Presentation #LBA44, Mini Oral
NeoPeLe: A Phase 2 Trial of Neoadjuvant (NAT) Pembrolizumab (Pembro) Combined With Lenvatinib (Lenva) In Resectable Stage III Melanoma. G. Long.	Presentation #793P, Poster
Pembrolizumab Versus Placebo After Complete Resection Of High-Risk Stage III Melanoma: 5-Year Results Of The EORTC 1325-MG/KEYNOTE-054 Double-Blinded Phase 3 Trial. A. Eggermont.	Presentation #804P, Poster

Solid tumors
Pembrolizumab In Microsatellite Instability-High (MSI-H)/Mismatch Repair Deficient (dMMR) Advanced Solid Tumors: An Update Of The Phase 2 KEYNOTE-158 Trial. M. Maio.	Presentation #113P, Poster

About Merck’s early-stage cancer clinical program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA^® (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA^® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

• stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
• metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):

• who are not eligible for any platinum-containing chemotherapy, or
• who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Non-muscle Invasive Bladder Cancer

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

• in combination with platinum- and fluoropyrimidine-based chemotherapy, or
• as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Cervical Cancer

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Endometrial Carcinoma

KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less.

Contacts

Media Contacts:

Melissa Moody

(215) 407-3536

Kristen Drake

(908) 740-1679

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Damini Chokshi

(908) 740-1807

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