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.

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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.

“We believe the robust clinical interest we have seen in the SHERLOC study reflects the significant unmet medical need among this patient population.”

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.”

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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.