Pivotal Studies for Pembrolizumab and Olaparib Selected for ESMO Presidential Symposium Sessions

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

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


San Francisco, CA (UroToday.com) -- Merck 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)
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.
Source: "New Scientific Data At The ESMO Virtual Congress 2020 Reflect Merck’S Commitment To Advancing Cancer Research And Care - Merck.Com". 2020. Merck.Com


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