Pivotal Merck/Kelun TROP2 studies seek nearly 10,000 patients

As if Merck & Co’s desire to take on Daiichi Sankyo/AstraZeneca in the TROP2-targeting ADC space was in any doubt, yet another phase 3 study of sacituzumab tirumotecan has just been listed on clinical trials registries. This will test the Kelun-originated anti-TROP2 ADC as maintenance after Keytruda plus chemo in first-line squamous NSCLC, and seeks to recruit 851 patients. It takes the number of Merck-sponsored pivotal trials of the project to nine, versus Kelun’s five, and the total number of patients to be enrolled into these efforts now stands at a remarkable 9,367. That’s an enormous bet to put on an asset for which Merck paid Kelun just $47m two years ago. For their part, Daiichi/Astra have so far taken datopotamab deruxtecan into 12 phase 3 studies, and two settings are already before the FDA: the agency is to rule on approval for second-line non-squamous NSCLC (Tropion-Lung01 study) in December, and on use in second-line ER-positive HER2-negative breast cancer (Tropion-Breast01) in February 2025.

Pivotal trials of sacituzumab tirumotecan

Note: *includes NSCLC driven by mutations in ALK, ROS1, BRAF, NTRK, MET or RET. Source: OncologyPipeline.