Merck to Present Survival Data and New Research Across 10 Approved or Investigational Oncology Products at ESMO 2024

Pembrolizumab for the Treatment of Early-Stage Female Cancers: Overall Survival (OS) Data release, including early high-risk triple-negative breast cancer (KEYNOTE-522) and high-risk locally advanced cervical cancer (KEYNOTE-A18), all of whom were selected to participate in the Chairman's Forum.

KEYNOTE-006Research10YearOSData andKEYNOTE-811Research UltimatelyOSData Release: Pembrolizumab Once Again Demonstrates Efficacy for Specific Advanced Melanoma andHER2The Important Role in Patients with Positive Gastric or Gastroesophageal Junction Adenocarcinoma

InESMOData released at the conference highlighted the company's antibody-drug conjugates (ADC) Progress of R&D pipeline, includingpatritumab deruxtecan（HER3-DXd）、sacituzumab tirumotecan（sac-TMT) andifinatamab deruxtecan（I-DXd）

Roway, New Jersey, USA,2024Year9Month4Day——MSD (the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, U.S.) announced that the company will present research data involving over 20 different types of cancer from its portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress held in Barcelona, Spain, from September 13 to 17. Data selected for the Presidential Symposium include: Phase III KEYNOTE-522 study (#LBA4) in early-stage high-risk triple-negative breast cancer, Phase III KEYNOTE-A18 study (#709O) in high-risk locally advanced cervical cancer, and Phase III LEAP-012 study (#LBA3) in unresectable non-metastatic hepatocellular carcinoma. A total of 80 abstracts from the company will be presented at the conference, further demonstrating MSD's continued advancement in clinical research across its broad portfolio and extensive pipeline.

      "Over the past decade, research data from pembrolizumab has driven a paradigm shift in the treatment of some fatal cancers and rewritten medical textbooks. On September 4 this year, it marks the tenth anniversary of pembrolizumab's first approval in the United States, and we are extremely proud."Senior Vice President of Merck Sharp & Dohme AG, Head of Global Clinical Development, Chief Medical OfficerEliav BarrDr. stated"The 10-year survival data for unresectable or metastatic melanoma, along with the new overall survival data for two types of early-stage female cancers released at this year's ESMO conference, are a testament to the remarkable development journey of pembrolizumab. We are very pleased to showcase our leadership in the field of cancer treatment through extensive and diversified pipeline data, aiming to benefit more patients."

      Data from the company’s product portfolio to be presented at this conference will include findings from pembrolizumab.^[1]、belzutifan^[2], Lenvatinib in collaboration with Eisai Co.^[3]And olaparib, which is collaborated with AstraZeneca^[4]Brand new or updated data.

Will be inESMOKey data from MSD's product portfolio presented at the conference include:

      In addition, the pipeline data to be released at the conference includes patritumab deruxtecan (HER3-DXd), a HER3-targeted ADC drug co-developed with Daiichi Sankyo.^[5]And ifinatamab deruxtecan (I-DXd, MK-2400)^[6], a TROP2-targeted antibody-drug conjugate (ADC) under co-development with Kelun-Biotech, sacituzumab tirumotecan (sac-TMT, MK-2870/SKB264)^[7]`, as well as the steroid synthesis inhibitor opevesostat (MK-5684/ODM-208) under development in collaboration with Orion Corporation`^[8]。

InESMOKey abstracts of the R&D pipeline disclosed at the meeting include:

More will be inESMOKey abstracts presented at the meeting include:

About MSD's Early-Stage Cancer Clinical Program

      Early detection and treatment of cancer can help patients achieve a greater chance of long-term survival. Currently, many cancers are considered treatable and potentially curable at an early stage of the disease. Based on the understanding of pembrolizumab for treating various advanced cancers, MSD is conducting approximately 30 registrational studies to explore the use of its product portfolio and pipeline for the treatment of various early-stage cancers.

Regarding the Strategic Collaboration between Eisai and MSD

      In March 2018, Eisai and MSD (MSD is the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, USA) initiated a strategic collaboration through their subsidiaries for the global co-clinical development and commercial promotion of lenvatinib. Under the agreement, both parties will conduct joint clinical development, manufacturing, and commercial promotion of lenvatinib as monotherapy or in combination with MSD’s PD-1 inhibitor pembrolizumab. Eisai and MSD are currently evaluating the combination of lenvatinib and pembrolizumab across multiple clinical trials involving various cancer types within the LEAP series of clinical programs.

AstraZeneca and MSD's Oncology Strategic Collaboration

      In July 2017, AstraZeneca and MSD (the corporate name of Merck & Co., Inc. in Kenilworth, New Jersey, U.S.) announced a global strategic collaboration in the field of oncology to jointly conduct clinical development and commercial promotion of certain oncology products, including olaparib, the world's first PARP inhibitor, across multiple cancer types. The two parties will work together to develop combination therapies with these products and potential new drugs as well as monotherapy regimens. At the same time, both companies will independently develop combination treatment plans for these products with their respective PD-L1 and PD-1 inhibitors.

About the Collaboration among Astellas, Pfizer, and MSD

      Astellas and Seagen, in collaboration with MSD, have signed a clinical cooperation agreement to evaluate the efficacy of Astellas and Seagen’s enfortumab vedotin-ejfy combined with MSD’s pembrolizumab in treating adult patients with previously untreated locally advanced or metastatic urothelial cancer. Pfizer completed its acquisition of Seagen on December 14, 2023.

Regarding the Collaboration between Daiichi Sankyo and MSD

      In October 2023, Daiichi Sankyo and MSD reached a global collaboration. Except for exclusive rights retained by Daiichi Sankyo in Japan, they will jointly conduct clinical development and commercial promotion of patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd). Daiichi Sankyo will be fully responsible for product manufacturing and supply.

 About MSD

      At MSD (the corporate name of Merck & Co., Inc. in the United States, headquartered in Rahway, New Jersey), we work together with a shared purpose: harnessing the power of leading-edge science to save and improve lives around the world. For over 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We are committed to being a top research-intensive biopharmaceutical company — today, we remain at the forefront of research, delivering innovative solutions to advance the prevention and treatment of diseases in humans and animals. We have built a diverse and inclusive global workforce that operates responsibly every day, ensuring a safe, sustainable, and healthy future for all people and communities. For more information, please visitwww.msd.com, and follow us on X (formerly Twitter), LinkedIn, and YouTube platforms.

 About MSD China

      China is a crucial part of MSD's global growth strategy. MSD’s China headquarters is located in Shanghai, with a research and development center in Beijing and manufacturing facilities in Hangzhou, Ningbo, and Tianjin, integrating R&D, manufacturing, and commercial operations. We are fully committed to providing the people of China with high-quality innovative medicines, vaccines, and services for the benefit of Chinese society. For more information, please visit MSD China's official website or follow MSD China's official social media accounts on WeChat.

 MSD Forward-Looking Statements

      MSD's global headquarters is located in Rahway, New Jersey, USA (hereinafter referred to as "the Company"). This press release contains "forward-looking statements" made under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. The content herein is based on the current views and expectations of the Company’s management and is subject to significant risks and uncertainties. MSD does not guarantee that its investigational products will receive the necessary regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties arise, actual results may differ materially from those anticipated in the forward-looking statements.

      Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors (including interest rate and currency fluctuations), the recent global outbreak of the novel coronavirus (COVID-19), the impact of pharmaceutical industry regulations and healthcare policies in the United States and other countries, the trend toward controlling healthcare costs globally, technological advancements, new products and patents obtained by competitors, inherent challenges in new product development (including obtaining regulatory approval), MSD's ability to accurately predict future market conditions, difficulties or delays in production, unstable international economic and financial conditions and sovereign risks, reliance on the effectiveness of MSD's patents and other innovative product protections, as well as the risk of patent litigation and/or regulatory actions against the company.

      MSD has no obligation to publicly update any forward-looking statements due to new information, future events, or other reasons. Other factors may cause actual results to materially differ from forward-looking statements; see MSD's 2023 Annual Report on Form 10-K and other documents filed with the U.S. Securities Exchange Commission (available at www.sec.gov).

[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:

[2] As of now, belzutifan has not been approved by the NMPA.

[3] As of now, the NMPA has approved the following indications for lenvatinib; other indications have not yet been approved:

[4] As of now, the NMPA has approved the following indications for olaparib, and other indications have not yet been approved:

[5] As of now, patritumab deruxtecan has not been approved by the NMPA.

[6] As of now, ifinatamab deruxtecan has not been approved by the NMPA.

[7] As of now, sacituzumab tirumotecan has not been approved by the NMPA.

[8] As of now, opevesostat has not been approved by the NMPA.