Merck Showcases Innovative Oncology Portfolio and Pipeline at ESMO 2023

Phase III Study KEYNOTE-A39/EV-302 Survival Data Released for the First Time, Exploring the Potential of Combination Therapy for Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma; Data Selected for ESMO Presidential Symposium and Official Press Conference

Key data from multiple evaluations of pembrolizumab for early-stage cancer will be released, including overall survival data from the KEYNOTE-671 study, as well as new or updated data from the KEYNOTE-A18, KEYNOTE-522, and KEYNOTE-756 studies.

Data from Phase III LITESPARK-005 Study Released for the First Time, Exploring the Potential of Belzutifan in Specific Previously Treated Advanced Renal Cell Carcinoma

Rahway, New Jersey, USA, October 10, 2023 – MSD (the corporate name of Merck & Co., Inc. in Rahway, New Jersey, USA) announced that the company will present research data on over 15 different types of cancer from October 20 to 24 at the annual meeting of the European Society for Medical Oncology (ESMO) in Madrid, Spain. The data presented at ESMO will showcase new or updated research findings for MSD’s oncology products, including pembrolizumab1, belzutifan2, lenvatinib3 (in collaboration with Eisai), and olaparib4 (in collaboration with AstraZeneca).

At the same time, the company will also share new research data on its R&D pipelines at the ESMO Annual Meeting, including KRASG12C inhibitor MK-10845 (as monotherapy or in combination with pembrolizumab), TROP2 antibody-drug conjugate (ADC) MK-2870 (SKB264) developed in collaboration with Kelun-Biotech, and the investigational personalized neoantigen therapy (INT) V940/mRNA-4157 developed in collaboration with Moderna.

Dr. Marjorie Green
Senior Vice President of Global Clinical Research, Merck & Co., Inc.
Leader of Advanced Tumor

At the ESMO 2023 Annual Meeting, we look forward to sharing research findings from our extensive portfolio and continuously expanding pipeline, showcasing our commitment to pioneering breakthrough innovations in oncology to address critical unmet needs of patients. Our ongoing efforts to explore earlier treatment options and create a positive impact remain driven by one goal – to bring more therapeutic options to patients in need.

Key abstracts to be presented at the ESMO conference include:

Phase III KEYNOTE-A39/EV-302 Study First Discloses Survival Data, Evaluating Pembrolizumab Combined with Enfortumab Vedotin for First-Line Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma (LBA6), Selected for ESMO Presidential Symposium and Official Press Conference

Phase III KEYNOTE-671 Study Reports Overall Survival (OS) Data, Evaluating Pembrolizumab in the Perioperative Setting (Pembrolizumab Plus Chemotherapy as Neoadjuvant Treatment, Followed by Pembrolizumab Monotherapy as Adjuvant Treatment) for Resectable Stage II, IIIA, and IIIB Non-Small Cell Lung Cancer (NSCLC) (LBA56)

Phase III KEYNOTE-A18 Study First Data Release: Evaluating Pembrolizumab Combined with Chemoradiotherapy for High-Risk Locally Advanced Cervical Cancer Patients (LBA38)

Phase III KEYNOTE-756 Study First Data Release: Evaluating Pembrolizumab Combined with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for Early-Stage ER+/HER2- Breast Cancer Patients (LBA21)

First Data from Phase III LITESPARK-005 Study Evaluating Belzutifan in Patients with Advanced Renal Cell Carcinoma (aRCC) Previously Treated with Immune Checkpoint Inhibitors and Anti-Angiogenic Agents (LBA88)

Phase III KEYNOTE-811 Study First Discloses Progression-Free Survival (PFS) and OS Data, Evaluating Pembrolizumab Combined with Trastuzumab and Chemotherapy for Advanced HER2-Positive Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Patients (1511O)

5-Year Event-Free Survival Update from the Phase III KEYNOTE-522 Study Evaluating Pembrolizumab Plus Neoadjuvant Chemotherapy Followed by Adjuvant Pembrolizumab Monotherapy in Patients with Early-Stage High-Risk Triple-Negative Breast Cancer (TNBC) (LBA18)

Updated Data from Phase IIb KEYNOTE-942/mRNA-4157-P201 Study Evaluating V940 (mRNA-4157) in Combination with Pembrolizumab for Adjuvant Treatment of High-Risk Melanoma (LBA49)

KRASG12C inhibitor MK-1084: First disclosure of safety and preliminary efficacy data, evaluating its use as a monotherapy in patients with solid tumors and in combination with pembrolizumab for NSCLC patients (663P)

A Phase I/II Study First Releases Phase II Cohort Data, Evaluating MK-2870 (SKB264) in Previously Treated Metastatic HR+/HER2- Breast Cancer Patients (380MO)

MSD Investor Activity

MSD will host an investor event on October 22 at 7:00 PM (CEST) during the ESMO Annual Meeting to share key data. The event will be held online. Investors, analysts, media, and the public can access the event by clicking "Read the original article."

More key data to be announced at the ESMO conference include:

References:
1. As of now, the National Medical Products Administration (NMPA) has approved the following indications for pembrolizumab, and other indications have not yet been approved:
For the treatment of unresectable or metastatic melanoma that has failed first-line therapy;

Approved by the National Medical Products Administration (NMPA) for first-line monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK), with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.

Editor: Bai Ji

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