Biopharmaceutical company Merrimack Pharmaceuticals has completed patient enrolment in one group of a two-cohort randomised Phase 2 study of MM-121 in HER2-negative breast cancer.
The study will assess MM-121 combined with paclitaxel in the neoadjuvant setting of HER2-negative breast cancer compared with the use of paclitaxel alone.
Merrimack translational research co-founder and vice president Gavin MacBeath said the study will help in finding out the efficacy of MM-121 in patients who have not yet seen prior therapies for their disease.
"It also gives us the opportunity to assess biomarkers at an early stage in cancer treatment, which we believe will allow us to better understand biomarker profiles being explored for MM-121," MacBeath added.
The fully human monoclonal antibody MM-121 targets ErbB3, a cell surface receptor implicated in tumour growth and survival.
The first cohort enrolled 100 patients considered HER2-negative; however, they are hormone sensitive as either estrogen receptor (ER) and/or progesterone receptor (PR) markers are positive.
Enrolment is ongoing in the second cohort, which will be comprised of patients with negative breast cancer (TNBC), which is diagnosed when a patient’s tumour tests negative for HER2, ER and PR biomarkers.
The company expects final results from the first cohort in the second half of 2013 and second cohort in 2014.
Patients from both groups will receive standard treatment with doxorubicin and cyclophosphamide subsequent to treatment with MM-121 and paclitaxel, or paclitaxel alone, and will be monitored until surgical resection.