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Fundado el 20 de mayo de 2013

New Scientific Data at the ESMO Virtual Congress 2020 Reflect Merck’s Commitment to Advancing Cancer Research and Care

Pivotal Studies for KEYTRUDA® (pembrolizumab) in Esophageal Cancer (KEYNOTE-590) and LYNPARZA® (olaparib) in Prostate Cancer (PROfound) Selected for ESMO Presidential Symposium Sessions

First-Time Data for Three Investigational Candidates From Merck’s Diverse and Advancing Early Pipeline to be Presented

Merck to Hold Virtual Investor Briefing to Discuss ESMO Highlights

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from its broad and diverse oncology development program will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from Sept. 19–21. Data spanning more than 15 types of cancer will be presented at the congress, with new findings from Merck’s portfolio of established medicines including KEYTRUDA, Merck’s anti-PD-1 therapy; LENVIMA® (lenvatinib, in collaboration with Eisai); and LYNPARZA (in collaboration with AstraZeneca). Pivotal Phase 3 data evaluating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal cancer from the KEYNOTE-590 trial (Abstract #LBA8) and LYNPARZA in patients with metastatic castration-resistant prostate cancer (mCRPC) from the PROfound trial (Abstract #610O) were selected for inclusion in ESMO Presidential Symposium sessions. Additionally, new findings will be shared for three of Merck’s novel investigational candidates: vibostolimab (MK-7684), an anti-TIGIT antibody; MK-4830, an antibody targeting ILT4; and MK-6482, an oral HIF-2α inhibitor.

At Merck, we are focused on further improving long-term outcomes for more patients living with cancer, and this commitment is reflected in the breadth and diversity of our oncology research program,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “At the ESMO Virtual Congress 2020, we look forward to sharing important new results including survival data for KEYTRUDA in esophageal cancer and long-term findings in lung cancer, melanoma, and head and neck cancer, as well as research from our expansive pipeline.”

Key data from Merck’s portfolio and pipeline to be presented at ESMO include:

KEYTRUDA

  • First-time data from the Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal cancer, which will be featured in an ESMO Presidential Symposium (Abstract #LBA8)
  • Five-year survival data from the Phase 3 KEYNOTE-024 trial evaluating KEYTRUDA for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 (tumor proportion score ≥50%) (Abstract #LBA51)
  • First presentation of distant metastasis-free survival data from the Phase 3 KEYNOTE-054 trial evaluating KEYTRUDA patients with high-risk Stage 3 melanoma following complete resection (Abstract #LBA46)
  • First presentation of long-term results from the Phase 3 KEYNOTE-048 trial evaluating KEYTRUDA monotherapy or in combination with chemotherapy for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (Abstract #915MO)

KEYTRUDA Plus LENVIMA

  • First-time data from the Phase 2 LEAP-004 study evaluating KEYTRUDA plus LENVIMA for the second-line treatment of patients with melanoma who progressed on anti-PD-1/PD-L1 therapy (Abstract #LBA44)
  • First-time data from the Phase 2 LEAP-005 study evaluating KEYTRUDA plus LENVIMA in six new tumor types including biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer (Abstract #LBA41)

LYNPARZA

  • Final overall survival (OS) results from the Phase 3 PROfound trial evaluating LYNPARZA in patients with mCRPC and homologous recombinant repair (HRR) gene alterations and whose disease had progressed on prior treatment with new hormonal agent treatments, which will be featured in an ESMO Presidential Symposium (Abstract #610O)
  • New five-year recurrence-free survival data from the Phase 3 SOLO-1 trial evaluating maintenance LYNPARZA in patients with newly diagnosed, advanced BRCA-mutated ovarian cancer (Abstract #811MO)

Pipeline

  • First-time data from a cohort expansion phase of a Phase 1b study evaluating vibostolimab in combination with KEYTRUDA in patients with anti-PD-1/PD-L1-naïve advanced NSCLC (Abstract #1410P)
  • First-time data from a cohort expansion phase of a Phase 1b study evaluating vibostolimab as monotherapy and in combination with KEYTRUDA in patients with anti-PD-1/PD-L1 refractory NSCLC (Abstract #1400P)
  • First-time data from a Phase 1 study evaluating MK-4830 in patients with advanced solid tumors (Abstract #524O)
  • First-time data evaluating MK-6482 in von Hippel-Lindau (VHL) disease patients with tumors other than renal cell carcinoma (RCC) and updated data in VHL patients with RCC (Abstract #LBA26)

Merck Investor Event

Merck will hold a virtual investor event in conjunction with the ESMO Virtual Congress 2020 on Tuesday, Sept. 22 from 8–9 a.m. E.T. Details will be provided at a date closer to the event at https://www.merck.com/investor-relations.

Details on Abstracts Listed Above and Additional Key Abstracts for Merck

KEYTRUDA

Classical Hodgkin Lymphoma

  • Abstract #886MO, Mini Oral: Health-Related Quality of Life (HRQoL) From KEYNOTE-204: A Phase 3, Randomized, Open-Label Study of Pembrolizumab (Pembro) vs Brentuximab Vedotin (BV) in Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL). P. Zinzani.

Colorectal Cancer

  • Abstract #396O, Proffered Paper: Health-Related Quality of Life (HRQoL) in Patients (Pts) Treated With Pembrolizumab (Pembro) vs Chemotherapy as First-Line Treatment in Microsatellite Instability-High (MSI-H) and/or Deficient Mismatch Repair (dMMR) Metastatic Colorectal Cancer (mCRC): Phase 3 KEYNOTE-177 Study. T. Andre.

Diffuse Large B-Cell Lymphoma

  • Abstract #890MO, Mini Oral: Phase 1 Alexander Study of AUTO3, the First CD19/22 Dual Targeting CAR T Cell, With Pembrolizumab in Patients with Relapsed/Refractory (R/R) DLBCL. E. Tholouli.

Esophageal Cancer

  • Abstract #LBA8, Proffered Paper: Pembrolizumab Plus Chemotherapy Versus Chemotherapy as First-Line Therapy in Patients With Advanced Esophageal Cancer: The Phase 3 KEYNOTE-590 Study. K. Kato.

Head and Neck Cancer

  • Abstract #LBA38, Proffered Paper: Pembrolizumab Versus Cetuximab, Concomitant With Radiotherapy (RT) in Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Results of the GORTEC 2015-01 “PembroRad” Randomized Trial. J. Bourhis.
  • Abstract #915MO, Mini Oral: Long-Term Outcomes From KEYNOTE-048: Pembrolizumab (Pembro) Alone or With Chemotherapy (Pembro+C) vs EXTREME (E) as First-Line (1L) Therapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC). R. Greil.

Lung Cancer

  • Abstract #LBA51, Proffered Paper: KEYNOTE-024 5-Year OS Update: First-Line (1L) Pembrolizumab (Pembro) vs Platinum-Based Chemotherapy (Chemo) in Patients (Pts) With Metastatic NSCLC and PD-L1 Tumor Proportion Score (TPS) ≥50%. J. Brahmer.
  • Abstract #1782MO, Mini Oral: Health-Related Quality of Life (HRQoL) in KEYNOTE-604: Pembrolizumab (Pembro) or Placebo Added to Etoposide and Platinum (EP) as First-Line Therapy for ES-SCLC. H. Kim.
  • Abstract #1896MO, Mini Oral: Volumetric PET Response Assessment Outperforms Conventional Criteria in Patients Receiving High-Dose Pembrolizumab for Malignant Mesothelioma. D. Christoph.

Melanoma

  • Abstract #LBA46, Proffered Paper: Pembrolizumab Versus Placebo After Complete Resection of High-Risk Stage III Melanoma: Final Results Regarding Distant Metastasis-Free Survival From the EORTC 1325-MG/KEYNOTE 054 Double-Blinded Phase 3 Trial. A. Eggermont.

Sarcoma

  • Abstract #1077MO, Mini Oral: PD1 Blockade With Pembrolizumab in Classic and Endemic Kaposi Sarcoma: A Multicenter Phase 2 Study. J. Delyon.
  • Abstract #1619O, Proffered Paper: High Clinical Benefit Rates of Single Agent Pembrolizumab in Selected Rare Sarcoma Histotypes: First Results of the AcSé Pembrolizumab Study. J. Blay.

Solid Tumors

  • Abstract #1027MO, Mini Oral: ALKS 4230 Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients (Pts) With Refractory Solid Tumors (ARTISTRY-1). U. Vaishampayan.

KEYTRUDA Plus LENVIMA (in collaboration with Eisai)

Lung Cancer

  • Abstract #1313P, E-Poster: Phase 3 LEAP-006 Safety Run-in (Part 1): 1L Pembrolizumab (Pembro) + Chemotherapy (Chemo) With Lenvatinib (Len) for Metastatic NSCLC. M. Nishio.

Melanoma

  • Abstract #LBA44, Proffered Paper: Lenvatinib (Len) Plus Pembrolizumab (Pembro) for Advanced Melanoma (Mel) That Progressed on a PD-1 or PD-L1 Inhibitor: Initial Results of LEAP-004. A. Arance Fernandez.

Renal Cell Carcinoma

  • Abstract #710P, E-Poster: Phase 2 Trial of Lenvatinib (Len) + Pembrolizumab (Pembro) for Progressive Disease After PD-1/PD-L1 Immune Checkpoint Inhibitor (ICI) in Metastatic Clear Cell (MCC) RCC: Results by Independent Imaging Review and Subgroup Analyses. C. Lee.

Solid Tumors

  • Abstract #LBA41, Proffered Paper: LEAP-005: Phase 2 Study of Lenvatinib (Len) Plus Pembrolizumab (Pembro) in Patients (Pts) With Previously Treated Advanced Solid Tumors. Z. Lwin.

LYNPARZA (in collaboration with AstraZeneca)

Ovarian Cancer

  • Abstract #LBA33, Mini Oral: Maintenance Olaparib Plus Bevacizumab (Bev) in Patients (Pts) With Newly Diagnosed Advanced High-Grade Ovarian Carcinoma (HGOC): Final Analysis of Second Progression-Free Survival (PFS2) in the Phase III PAOLA-1/ENGOT-ov25 Trial. A. Martin.
  • Abstract #811MO, Mini Oral: Maintenance Olaparib for Patients (Pts) With Newly Diagnosed, Advanced Ovarian Cancer (OC) and a BRCA Mutation (BRCAm): 5-Year (Y) Follow-up (F/U) From SOLO1. S. Banerjee.
  • Abstract #812MO, Mini Oral: Maintenance Olaparib + Bevacizumab (Bev) in Patients (Pts) With Newly Diagnosed Advanced High-Grade Ovarian Cancer (HGOC): RECIST and/or CA-125 Objective Response Rate (ORR) in the Phase III PAOLA-1 Trial. N. Colombo.
  • Abstract #813MO, Mini Oral: Efficacy of Subsequent Chemotherapy for Patients With BRCA1/2 Mutated Platinum-Sensitive Recurrent Epithelial Ovarian Cancer (EOC) Progressing on Olaparib vs Placebo: The SOLO2/ENGOT Ov-21 Trial. J. Frenel.

Prostate Cancer

  • Abstract #610O, Proffered Paper: Final Overall Survival (OS) Analysis of PROfound: Olaparib vs Physician’s Choice of Enzalutamide or Abiraterone in Patients (Pts) With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Homologous Recombination Repair (HRR) Gene Alterations. J. De Bono.

Vibostolimab

Lung Cancer

  • Abstract #1400P, E-Poster: Vibostolimab, an Anti–TIGIT Antibody, as Monotherapy and in Combination With Pembrolizumab in Anti–PD-1/PD-L1-Refractory NSCLC. M. Ahn.
  • Abstract #1410P, E-Poster: Safety and Efficacy of Vibostolimab, an Anti-TIGIT Antibody, Plus Pembrolizumab in Patients With Anti-PD-1/PD-L1-Naïve NSCLC. J. Niu.

MK-4830

Solid Tumors

  • Abstract #524O, Proffered Paper: Initial Results of a Phase 1 Study of MK-4830, a First-in-Class Anti-Immunoglobulin-Like Transcript 4 (ILT4) Myeloid-Specific Antibody in Patients (Pts) With Advanced Solid Tumors. L. Siu.

MK-6482

Von-Hippel Lindau Disease

  • Abstract #LBA26, Mini Oral: Phase 2 Study of the Oral HIF-2α Inhibitor MK-6482 for Von Hippel-Lindau (VHL) Disease-Associated Clear Cell Renal Cell Carcinoma (ccRCC): Update on RCC and Non-RCC Disease. R. Srinivasan.

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-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 1,200 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

Melanoma

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

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) 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.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. 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 confirmatory trials.

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 head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. 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.

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. 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 confirmatory trials. 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 cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 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.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) 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 that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
  • colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

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 first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. 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.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA 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. 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.

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 patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, 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 and are not candidates for curative surgery or radiation. 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 trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] 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) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Kristen Drake

(908) 740-1679

Investors:

Peter Dannenbaum

(908) 740-1037

Courtney Ronaldo

(908) 740-6132

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