Merck and 3D Medicines Announce Clinical Collaboration to Evaluate Novel 'Targeted Therapy + Immuno-Oncology' Combination for Metastatic Colorectal Cancer
Mar 15, 2022 10:46
CST Updated
10:46
Merck Group
Pharmaceutical R&D Developer
On March 15, 2022, Merck Group, a global leading technology company, and 3D Medicines (a pharmaceutical company focused on oncology treatment that has entered the commercialization stage), announced a clinical research partnership. The collaboration will conduct clinical studies on the combination therapy of Merck’s epidermal growth factor receptor (EGFR) inhibitor Erbitux® (Cetuximab) and 3D Medicines’ globally first subcutaneously injectable PD-L1 antibody drug Envada® (Envonilimab) to evaluate the clinical efficacy of this combination in patients with metastatic colorectal cancer who are RAS/BRAF wild-type, non-MSI-H/pMMR, and have failed treatment with fluorouracil, oxaliplatin, irinotecan, and bevacizumab (excluding subjects with contraindications to bevacizumab treatment, those unsuitable according to treatment guidelines, and those unable to receive bevacizumab treatment due to financial reasons).
Rogier Janssens, Managing Director of Merck's Healthcare Business in China, stated, "Merck is committed to becoming a global innovator in specialty medicines. This partnership fully integrates the strengths of Merck and 3D Medicines in the field of oncology treatment to explore the effects of targeted and immuno-oncology combination therapies, aiming to provide better and more effective treatment options for patients with metastatic colorectal cancer in China."
Dr. Zhaolong Gong, Chairman and CEO of 3D Medicines, stated: "We are very pleased to have reached this clinical collaboration with Merck KGaA. Envada® is a safe, effective, and differentiated subcutaneous injection PD-L1 inhibitor. Early studies have shown that the combination of Envada® and Erbitux® has a certain synergistic effect, with the potential to achieve positive treatment outcomes across various cancer indications. We look forward to this combination therapy offering a more effective treatment option for patients with metastatic colorectal cancer."
Cetuximab (Erbitux®) is an IgG1 monoclonal antibody that specifically targets the epidermal growth factor receptor (EGFR), inhibiting the activation of the EGFR receptor, thereby suppressing the proliferation and invasion of tumor cells. Additionally, it exhibits antibody-dependent cell-mediated cytotoxicity, exerting an anti-tumor immune effect. Moreover, cetuximab can enrich a higher number of CD8+ T lymphocytes, thus enhancing the efficacy of immune checkpoint inhibitors (PD-1/PD-L1). Cetuximab has been approved in China for the treatment of RAS wild-type metastatic colorectal cancer and as a first-line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Envada® (Envonliumab) is the world’s first and only approved subcutaneous injection PD-L1 inhibitor. It has been approved for treating patients with previously treated MSI-H/dMMR advanced solid tumors. Meanwhile, Envada® has demonstrated therapeutic effects in various tumors and shows potential for enhanced efficacy when combined with other drugs. Currently, 3D Medicines(Shanghai) Co., Limited has initiated multiple clinical studies on combination therapies for various cancer indications, including combinations with Chidamide, Lenvatinib, and 3D229 (a differentiated GAS6-AXL signaling pathway inhibitor), which are expected to achieve better treatment outcomes in a variety of advanced solid tumors.
About Erbitux® (Cetuximab Injection)
Cetuximab is the world's first IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody drug, cetuximab targets and binds to EGFR, and this binding inhibits receptor activation and downstream signaling, thereby suppressing tumor cell invasion and spread into normal tissues. Additionally, cetuximab can inhibit the ability of tumor cells to repair damage caused by chemotherapy and radiotherapy, as well as suppress the formation of new blood vessels within the tumor, thus overall inhibiting tumor growth. Based on in vitro research evidence, cetuximab also exhibits antibody-dependent cell-mediated cytotoxicity (ADCC), which exerts an immune effect against tumors.
To date, Erbitux® has been approved in more than 100 countries/regions worldwide for the treatment of RAS wild-type metastatic colorectal cancer (mCRC) and recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
About Envada® (Envonli Monoclonal Antibody Injection)
Envada® (Envonli Monoclonal Antibody Injection) was independently developed by Alphamab Oncology. Since 2016, it has been jointly developed with 3D Medicines(Shanghai) Co., Limited. On March 30, 2020, Alphamab Oncology, 3D Medicines(Shanghai) Co., Limited, and Simcere Pharmaceutical Group reached a strategic cooperation. As the original R&D party, Alphamab Oncology is responsible for production and quality, 3D Medicines(Shanghai) Co., Limited is responsible for clinical development in the field of oncology, and Simcere Pharmaceutical Group is responsible for the exclusive commercial promotion of the product in mainland China.
Based on its unique design, Envada offers advantages in terms of safety, convenience, and compliance. Patients do not need to undergo intravenous infusion, and it is expected to reduce medical costs. Currently, clinical trials for multiple tumor indications are being conducted simultaneously in China, the United States, and Japan, with several indications having entered the registration/Phase III clinical stage. Envada has been granted Orphan Drug Designation by the U.S. FDA for advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envada was officially approved for marketing in China, indicated for the treatment of adult patients with unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors, including patients with advanced colorectal cancer who have progressed after prior treatment with fluorouracil, oxaliplatin, and irinotecan, as well as other patients with advanced solid tumors who have progressed after previous treatments and have no satisfactory alternative treatment options.
Rogier Janssens, Managing Director of Merck's Healthcare Business in China, stated, "Merck is committed to becoming a global innovator in specialty medicines. This partnership fully integrates the strengths of Merck and 3D Medicines in the field of oncology treatment to explore the effects of targeted and immuno-oncology combination therapies, aiming to provide better and more effective treatment options for patients with metastatic colorectal cancer in China."
Dr. Zhaolong Gong, Chairman and CEO of 3D Medicines, stated: "We are very pleased to have reached this clinical collaboration with Merck KGaA. Envada® is a safe, effective, and differentiated subcutaneous injection PD-L1 inhibitor. Early studies have shown that the combination of Envada® and Erbitux® has a certain synergistic effect, with the potential to achieve positive treatment outcomes across various cancer indications. We look forward to this combination therapy offering a more effective treatment option for patients with metastatic colorectal cancer."
Cetuximab (Erbitux®) is an IgG1 monoclonal antibody that specifically targets the epidermal growth factor receptor (EGFR), inhibiting the activation of the EGFR receptor, thereby suppressing the proliferation and invasion of tumor cells. Additionally, it exhibits antibody-dependent cell-mediated cytotoxicity, exerting an anti-tumor immune effect. Moreover, cetuximab can enrich a higher number of CD8+ T lymphocytes, thus enhancing the efficacy of immune checkpoint inhibitors (PD-1/PD-L1). Cetuximab has been approved in China for the treatment of RAS wild-type metastatic colorectal cancer and as a first-line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Envada® (Envonliumab) is the world’s first and only approved subcutaneous injection PD-L1 inhibitor. It has been approved for treating patients with previously treated MSI-H/dMMR advanced solid tumors. Meanwhile, Envada® has demonstrated therapeutic effects in various tumors and shows potential for enhanced efficacy when combined with other drugs. Currently, 3D Medicines(Shanghai) Co., Limited has initiated multiple clinical studies on combination therapies for various cancer indications, including combinations with Chidamide, Lenvatinib, and 3D229 (a differentiated GAS6-AXL signaling pathway inhibitor), which are expected to achieve better treatment outcomes in a variety of advanced solid tumors.
About Erbitux® (Cetuximab Injection)
Cetuximab is the world's first IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody drug, cetuximab targets and binds to EGFR, and this binding inhibits receptor activation and downstream signaling, thereby suppressing tumor cell invasion and spread into normal tissues. Additionally, cetuximab can inhibit the ability of tumor cells to repair damage caused by chemotherapy and radiotherapy, as well as suppress the formation of new blood vessels within the tumor, thus overall inhibiting tumor growth. Based on in vitro research evidence, cetuximab also exhibits antibody-dependent cell-mediated cytotoxicity (ADCC), which exerts an immune effect against tumors.
To date, Erbitux® has been approved in more than 100 countries/regions worldwide for the treatment of RAS wild-type metastatic colorectal cancer (mCRC) and recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
About Envada® (Envonli Monoclonal Antibody Injection)
Envada® (Envonli Monoclonal Antibody Injection) was independently developed by Alphamab Oncology. Since 2016, it has been jointly developed with 3D Medicines(Shanghai) Co., Limited. On March 30, 2020, Alphamab Oncology, 3D Medicines(Shanghai) Co., Limited, and Simcere Pharmaceutical Group reached a strategic cooperation. As the original R&D party, Alphamab Oncology is responsible for production and quality, 3D Medicines(Shanghai) Co., Limited is responsible for clinical development in the field of oncology, and Simcere Pharmaceutical Group is responsible for the exclusive commercial promotion of the product in mainland China.
Based on its unique design, Envada offers advantages in terms of safety, convenience, and compliance. Patients do not need to undergo intravenous infusion, and it is expected to reduce medical costs. Currently, clinical trials for multiple tumor indications are being conducted simultaneously in China, the United States, and Japan, with several indications having entered the registration/Phase III clinical stage. Envada has been granted Orphan Drug Designation by the U.S. FDA for advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envada was officially approved for marketing in China, indicated for the treatment of adult patients with unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors, including patients with advanced colorectal cancer who have progressed after prior treatment with fluorouracil, oxaliplatin, and irinotecan, as well as other patients with advanced solid tumors who have progressed after previous treatments and have no satisfactory alternative treatment options.