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FDA Grants Breakthrough Therapy Designation to Merck’s Sacituzumab Tirumotecan for EGFR-Mutated NSCLC

NextEdge Admin

04 Dec 2024

2 min 40 sec

Breakthrough Therapy,ADC,investigational drug

Merck , known as MSD outside the U.S. and Canada, announced that the U.S. FDA has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutations (exon 19 deletion or exon 21 L858R). This designation applies to patients whose disease progressed after tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. Sac-TMT is an investigational TROP2-directed antibody-drug conjugate (ADC) developed in collaboration with Kelun-Biotech.

The designation is based on promising results from the Phase 2 expansion cohort of a Phase 1/2 study and additional data from a Phase 2 study, which were presented at the 2023 ASCO Annual Meeting. Breakthrough Therapy status aims to expedite the development of therapies showing substantial improvement over existing treatments for serious conditions, granting access to enhanced FDA guidance, a scientific liaison, and potential Priority Review.

Merck is actively advancing sac-TMT in global clinical programs, including 10 Phase 3 studies across multiple solid tumors. Key trials for EGFR-mutated NSCLC include TroFuse-004, comparing sac-TMT to chemotherapy (docetaxel or pemetrexed), and TroFuse-009, comparing sac-TMT to doublet chemotherapy (pemetrexed and carboplatin). These are the only Phase 3 studies evaluating a TROP2 ADC in this patient population.

Sac-TMT has also been approved in China for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) following at least two prior systemic therapies, based on the Phase 3 OptiTROP-Breast01 study. Under their collaboration, Kelun-Biotech retains development and commercialization rights in Greater China.

“This FDA designation underscores the potential of ADCs to improve outcomes in challenging cancers,” said Dr. Scot Ebbinghaus, VP of Global Clinical Development, Merck Research Laboratories.