RE:RE:RE:Antibody-drug conjugates (ADCs) company CCO departsThe Phase II HERMIONE trial (NCT02213744) which involved MM-302, the anti-HER2 monoclonal antibody conjugated to doxorubicin, was discontinued due to a lack of benefit from a placebo treatment.
Another ADC that reported a similar situation was Rovalpitumab tesirine (RovA-T), encouraging results from the Phase I trial reported 18% ORR in assessable patients, 38% ORR in patients with high DLL3 expression (NCT01901653). However, safety and efficacy issues were raised due to the results of the Phase II trial TRINITY (NCT02674568), which did not meet the primary endpoint and reported high toxicity rates.
The most common event in patients was pleural effusion, which was thought to be toxic in association with PBDE dimers. Ultimately, results from the Phase III trials TAHOE (NCT03061812) and MERU (NCT03033511) resulted in AbbVie completely discontinuing the development of RovA-T, with a lack of survival benefit compared to the control group.