Merck to Present New Data Across Multiple Oncology Products and Investigational Pipeline at ASCO20

Pembrolizumab Treatment for MSI-H/dMMRColorectal Cancer^[1]IIIPhase clinical study data will be presented at ASCOPlenary Session Release

Pembrolizumab for the Treatment of Triple-Negative Breast Cancer^[1] Classical Hodgkin Lymphoma^[1]、Non-Small Cell Lung Cancer^[2] Renal Cell Carcinoma^[1]and melanoma^[2] and more than 15 types of cancer^[2] New research data or long-term follow-up data will be released during the conference

Olaparib^[3]and pembrolizumab^[2]Combined with Lenvatinib^[4]New research data will be released during the conference.

MSD Investigational Oral HIF-2α Inhibitor (MK-6482) for the Treatment of Von Hippel-Lindau-Associated Renal Cell Carcinoma^[5]Research data will be released for the first time during the conference.

Kenilworth, New JerseyMay 13, 2020/PR Newswire/ -- MSD (known as Merck & Co., Inc. in the United States and Canada,Kenilworth, New Jersey, USA）May 7Announced that the company will present the latest data from its oncology research programs at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Meeting, held from May 29 to 31. More than 80 study abstracts covering both marketed oncology products and investigational candidates have been accepted by the conference, spanning nearly 20 types of solid tumors and hematologic malignancies. These include Merck’s PD-1 inhibitor pembrolizumab, lenvatinib in collaboration with Eisai Co., Ltd., olaparib in collaboration with AstraZeneca, and the investigational oral hypoxia-inducible factor-2α (HIF-2α) inhibitor MK-6482 (formerly known as PT2977).

“Facing the global challenges brought by the COVID-19 pandemic, MSD will continue to fully support academic exchanges in the field of oncology and promote important scientific research in this area,” said Dr. Roy Baynes, Senior Vice President of Global Clinical Research and Chief Medical Officer at MSD Laboratories. “The data presented by MSD at ASCO this year will further demonstrate our deep and diverse product pipeline, continuing to deliver meaningful clinical outcomes for patients with new types of cancer and across different disease stages; meanwhile, the release of long-term follow-up data in the treatment of non-small cell lung cancer, renal cell carcinoma, and melanoma will further reinforce pembrolizumab’s key role in these cancer therapies.”

Key abstracts to be presented at the ASCO meeting include:

AstraZeneca and MSD's Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck & Co., Inc. (known as MSD in the United States and Canada),Kenilworth, New Jersey, USA) announced a global strategic collaboration in oncology to jointly pursue clinical development and commercialization of olaparib, the world’s first PARP inhibitor, and selumetinib, a promising novel MEK inhibitor, across multiple tumor indications. The two parties will collaborate on the development of combination therapies involving olaparib and selumetinib with other potential new drugs, as well as monotherapy regimens. Meanwhile, both companies will independently develop combination treatment strategies pairing olaparib and selumetinib with their respective PD-L1 and PD-1 inhibitors.

Strategic Collaboration between Eisai and MSD

In March 2018, Eisai and Merck & Co., Inc. (known as MSD in the United States and Canada),Kenilworth, New Jersey, USA) is conducting strategic cooperation through its subsidiaries to jointly carry out clinical development and commercial promotion of lenvatinib on a global scale. According to the agreement, both parties will jointly conduct clinical development, production, and commercial promotion of lenvatinib as monotherapy or in combination with Merck’s PD-1 inhibitor pembrolizumab.

In addition to the ongoing clinical studies evaluating the combination of lenvatinib and pembrolizumab across multiple tumor types, the two parties will jointly conduct several new clinical trials under the LEAP clinical program to assess the combination regimen for 16 potential indications across 13 cancer types (endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, urothelial carcinoma, biliary tract cancer, colorectal cancer, gastric cancer, malignant glioma, ovarian cancer, and triple-negative breast cancer).

[1] To date, the National Medical Products Administration (NMPA) has not approved pembrolizumab for indications in this therapeutic area.

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

- For the treatment of unresectable or metastatic melanoma that has progressed after first-line therapy
- Combination therapy with pemetrexed and platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-squamous NSCLC in patients negative for EGFR/ALK gene mutations
- Indicated for first-line monotherapy in patients with locally advanced or metastatic NSCLC assessed as PD-L1 positive (TPS ≥1%) by an NMPA-approved test and negative for EGFR/ALK gene mutations
- The combination of carboplatin and paclitaxel is indicated for first-line treatment of metastatic squamous NSCLC

[3] To date, the NMPA has approved olaparib for the following indications; other indications have not yet been approved:

- For maintenance treatment of platinum-sensitive recurrent ovarian cancer
- For first-line maintenance treatment in patients with advanced ovarian cancer harboring BRCA mutations

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

- For the treatment of patients with unresectable hepatocellular carcinoma who have not previously received systemic therapy

[5] As of now, the NMPA has not approved MK-6482 for indications in this therapeutic area.