RAHWAY, N.J. - Merck (NS:PROR) & Co. Inc. (NYSE:MRK), a global healthcare leader, announced today that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to its investigational drug sacituzumab tirumotecan (sac-TMT) for the treatment of a specific type of lung cancer. This designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
Sac-TMT, a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC), is being developed to treat patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that exhibits epidermal growth factor receptor (EGFR) mutations and has progressed despite previous treatments with tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
This FDA designation was based on results from a Phase 2 expansion cohort of a Phase 1/2 study, which were presented at the 2023 American Society of Clinical Oncology Annual Meeting. Additionally, data from two parts of a Phase 2 study evaluating sac-TMT in patients with EGFR-mutated NSCLC who have undergone at least two lines of prior therapy contributed to this milestone.
Dr. Scot Ebbinghaus, vice president of global clinical development at Merck Research Laboratories, emphasized the significance of developing innovative treatments for patients with EGFR-mutated NSCLC. Merck is advancing the clinical development of sac-TMT with the aim of improving upon the current standards of care for certain cancers. As a prominent player in the pharmaceuticals industry, Merck's commitment to innovation is backed by substantial financial resources, with $14.8 billion in levered free cash flow over the last twelve months. According to InvestingPro's analysis, which offers comprehensive insights through its Pro Research Reports covering over 1,400 US stocks, the company appears to be trading below its Fair Value, presenting a potential opportunity for investors.
The Breakthrough Therapy Designation provides benefits such as more intensive FDA guidance on an efficient development program, a scientific liaison to help accelerate review time, and potential eligibility for Priority Review if relevant criteria are met.
Merck's global clinical development program for sac-TMT includes ongoing Phase 3 studies, evaluating the drug both as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) across various solid tumors. Notably, sac-TMT has already received its first marketing authorization in China for the treatment of triple-negative breast cancer (TNBC), based on the results from the Phase 3 OptiTROP-Breast01 study.
Lung cancer remains the leading cause of cancer death worldwide, with NSCLC making up about 80% of all lung cancer cases. EGFR mutations are found in a significant proportion of NSCLC tumors globally. The five-year survival rate for patients diagnosed with lung cancer in the United States stands at 25% as of 2024, with early detection and new therapies contributing to improved survival rates.
The information in this article is based on a press release statement from Merck & Co., Inc.
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