KENILWORTH (NJ) (dpa-AFX) - Merck & Co., Inc. (MRK) announced Tuesday that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) to treat advanced or metastatic nonsquamous non-small cell lung cancer with epidermal growth factor receptor or EGFR mutations.
Sac-TMT is an investigational trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) being developed in collaboration with Kelun-Biotech.
The FDA granted the designation based on data from the Phase 2 expansion cohort of a Phase 1/2 study evaluating sac-TMT in patients with EGFR-mutated nonsquamous non-small cell lung cancer or NSCLC, as well as data from two parts of a Phase 2 study evaluating sac-TMT in patients with EGFR-mutated NSCLC who have been treated with at least two lines of prior therapy.
The treatment is for patients of advanced or metastatic nonsquamous NSCLC with EGFR mutations, whose disease progressed on or after tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
The Breakthrough Therapy designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions.
Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories, said, 'This designation by the FDA highlights the importance of developing novel therapeutic options for patients living with EGFR-mutated nonsquamous non-small cell lung cancer. We believe ADCs are an important modality in the treatment of cancer and are rapidly advancing the clinical development of sacituzumab tirumotecan, with the goal of meaningfully improving upon current standards of care in certain cancers.'
Merck said it is rapidly advancing the global clinical development program evaluating sac-TMT as a monotherapy and in combination with KEYTRUDA (pembrolizumab) with 10 ongoing Phase 3 studies across various solid tumors.
Sac-TMT recently received its first marketing authorization in China from the National Medical Products Administration to treat adult patients with certain unresectable locally advanced or metastatic triple-negative breast cancer or TNBC.
Sac-TMT was developed by Kelun-Biotech, a holding subsidiary of Kelun Pharmaceutical. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China, while it maintains the rights in Greater China, which includes Mainland China, Hong Kong, Macau and Taiwan.
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