Merck widens its TROP2 ambitions

Merck & Co is expanding its already extensive clinical programme for the Kelun-originated TROP2-directed antibody-drug conjugate sacituzumab tirumotecan, adding yet another pivotal trial to its growing list. According to a new entry on clinicaltrials.gov, the Trofuse-036 study will test the ADC in combination with Keytruda, against Keytruda plus Avastin in first-line maintenance treatment of cervical cancer, and is expected to start in November. With this addition Merck now has 15 clinical studies under way for sacituzumab tirumotecan, collectively targeting nearly 15,000 patients across a broad range of tumour types, including breast, lung, gastric, endometrial and ovarian. The targeted pitoval enrolment now includes 1,700 patients with cervical cancer, where the new phase 3 trial will be the second for the asset in this use. Trofuse-036's maintenance phase measures PFS and OS as co-primary endpoints, and the trial at present isn't due to complete until 2031. Notably, no other TROP2-targeting ADCs are currently being evaluated in any phase 3 studies in cervical cancer.

Sacituzumab tirumotecan's pivotal trials in cervical cancer

Source: OncologyPipeline.