Merrimack Pharmaceuticals has concluded enrolment in the SHERLOC study, a Phase ll clinical trial designed to examine MM-121 (seribantumab) in combination with docetaxel versus docetaxel alone to treat patients with heregulin positive Non-Small Cell Lung Cancer (NSCLC).
The global, randomised, biomarker-selected, open-label trial has enrolled 109 NSCLC patients, who underwent a biomarker screen for high-tumour expression of heregulin, the signal for the human epidermal growth factor receptor 3 (HER3), commonly found in solid tumours.
The enrolled patients also received a platinum-based therapy and immunotherapy previously.
The trial’s primary endpoint is progression-free survival, while its major secondary endpoints include response rate, time to progression and overall survival.
Top-line data from the trial is expected to be available in the second half of this year.
Merrimack Pharmaceuticals senior medical director and MM-121 project leader J Marc Pipas said: “We believe the robust clinical interest we have seen in the SHERLOC study reflects the significant unmet medical need among this patient population.”
MM-121 is Merrimack’s lead investigational drug candidate and a fully human anti-HER3 (ErbB3) monoclonal antibody that is designed to target phenotypically distinct, heregulin-positive cancer cells within solid tumours.
Heregulin-positive cancer cells have the ability to escape the effects of targeted, cytotoxic and anti-endocrine therapies and can be detected by RNA-ISH.
Detecting heregulin positive cancer cells by RNA-ISH could pinpoint tumours at risk for rapid clinical progression.
Merrimack noted that seribantumab, when used in combination with other solutions, can block the heregulin/HER3 signalling axis to make the heregulin-positive cancer cells more responsive to the effects of the combination therapy and provide improved clinical results.