Merrimack Completes Enrollment in Randomized Phase 2 SHERLOC Study of MM-121 (seribantumab) in Non-Small Cell Lung Cancer (NSCLC)
"We believe the robust clinical interest we have seen in the SHERLOC study reflects the significant unmet medical need among this patient population," said J. Marc Pipas, M.D., Merrimack's Senior Medical Director and Project Leader for MM-121. "With gratitude to our team and, of course, to investigators and patients for their commitment to advancing cancer care, we are pleased to have achieved this clinical milestone and look forward to reporting the results from this event-driven study in the coming months."
The SHERLOC study is a global, randomized, biomarker-selected, open-label Phase 2 clinical trial of MM-121 in combination with docetaxel, versus docetaxel alone, in patients with heregulin positive NSCLC. The primary endpoint of the trial is progression-free survival, with objective response rate, time to progression and overall survival as key secondary endpoints. Under the current protocol amendment, the trial enrolled 109 patients with NSCLC, all of whom underwent a biomarker screen for high tumor expression of heregulin, the signal for the HER3 receptor that is prevalent in solid tumors. Patients were also required to have received a prior platinum-based therapy, as well as prior immunotherapy where available and clinically indicated. Merrimack continues to anticipate top-line data from this trial in the second half of 2018.
MM-121, also known as seribantumab, is Merrimack's wholly owned, fully human anti-HER3 (ErbB3) monoclonal antibody that targets phenotypically distinct heregulin positive cancer cells within solid tumors. Heregulin positive cancer cells are characterized by their ability to escape the effects of targeted, cytotoxic and anti-endocrine therapies. Identification of heregulin positive cancer cells by RNA-ISH may identify tumors at risk for rapid clinical progression. Seribantumab, when used in the combination setting, is designed to block the heregulin/HER3 signaling axis to make these cells more responsive to the effects of the combination therapy and deliver improved clinical outcomes.
In addition to the SHERLOC clinical trial, MM-121 is also being evaluated in the global, randomized, biomarker-selected, double-blinded, placebo-controlled, Phase 2 SHERBOC clinical trial of MM-121 in combination with fulvestrant, versus fulvestrant alone, in patients with heregulin positive, hormone receptor positive, ErbB2 (HER2) negative, metastatic breast cancer.
Merrimack is a biopharmaceutical company based in
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