Seribantumab (MM-121) has received Fast Track designation from the FDA for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy.
Fast Track is a program designed by the FDA to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. The SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC, is being conducted and designed to support a Biologics License Application to the FDA. Seribantumab is a fully human monoclonal antibody that targets ErbB3.
Heregulin-positive disease has been linked to rapid progression and poor prognosis in multiple types of cancer, including NSCLC. The higher the prevalence of heregulin-positive cancer cells in a tumor, the lower the anti-tumor effect of the chemotherapy. Seribantumab is designed to block heregulin-driven signaling and enhance the anti-tumor effect of the chemotherapy. Data from prior clinical studies have shown standard-of-care therapy may be more effective and result in improved patient outcomes when combined with seribantumab. The efficacy and safety of seribantumab plus standard-of-care therapy is being investigated in the SHERLOC trial.