Merck (NYSE: MRK) is strategically expanding its pipeline through licensing agreements and pipeline adjustments, focusing on innovative therapies while streamlining its immuno-oncology programs. The company recently closed an exclusive global license agreement with LaNova Medicines Ltd. for LM-299, a promising anti-PD-1/VEGF bispecific antibody. Simultaneously, Merck has entered into an exclusive global license agreement with Hansoh Pharma for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist.
LM-299: A Novel Bispecific Antibody
Under the agreement with LaNova Medicines Ltd., Merck will assume responsibility for the development, manufacturing, and commercialization of LM-299. This bispecific antibody targets both PD-1 and VEGF, two key pathways involved in tumor growth and immune evasion. By simultaneously blocking these targets, LM-299 has the potential to offer enhanced anti-tumor activity compared to targeting either pathway alone. The closing of this deal, announced December 20, 2024, signifies Merck's commitment to exploring novel immunotherapeutic approaches.
HS-10535: Oral GLP-1 Receptor Agonist
Merck's collaboration with Hansoh Pharma, a Chinese biopharmaceutical company, focuses on HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist. This agreement, announced December 18, 2024, highlights Merck's interest in expanding its portfolio in metabolic diseases. Oral GLP-1 receptor agonists represent a convenient and potentially effective treatment option for patients with type 2 diabetes. The collaboration with Hansoh Pharma provides Merck with access to a promising asset in this therapeutic area.
Immuno-oncology Program Updates
In a strategic portfolio update on December 16, 2024, Merck announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody. These antibodies were being evaluated in investigational fixed-dose combinations with pembrolizumab (KEYTRUDA®) in the KeyVibe and KEYFORM programs, respectively. The decision to discontinue these programs was based on a review of the emerging data and the evolving treatment landscape. While these programs will not continue, Merck remains committed to advancing its immuno-oncology pipeline through other innovative approaches.
Keytruda Approved in China for NSCLC
On a positive note for Merck's oncology pipeline, KEYTRUDA (pembrolizumab) has been approved by the National Medical Products Administration (NMPA) in China for use in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by adjuvant monotherapy after surgery, for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). This approval marks a significant advancement in the treatment of NSCLC in China, providing a new option for patients with this challenging disease.
Lynparza Demonstrates Prolonged Survival Benefit in Early Breast Cancer
Long-term results from the OlympiA Phase 3 trial, announced December 11, 2024, demonstrated that LYNPARZA (olaparib) showed sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) for people with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer. LYNPARZA is co-developed and co-commercialized by AstraZeneca and Merck.
Zilovertamab Vedotin Shows Promise in Diffuse Large B-Cell Lymphoma
Merck also announced data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), in combination with cyclophosphamide, doxorubicin and prednisone plus rituximab (R-CHP) for the treatment of patients with previously untreated diffuse large B-cell lymphoma. The combination demonstrated a 100% complete response rate at the 1.75 mg/kg dose.
