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FDA grants fast track status to MM-121 for NSCLC
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The FDA granted fast track designation to seribantumab for the treatment of non–small cell lung cancer, according to a press release from the agent’s manufacturer.
Seribantumab (MM-121, Merrimack Pharmaceuticals) is indicated for patients with heregulin-positive, locally advanced or metastatic disease that progressed after immunotherapy.
Seribantumab — a fully human, anti-ErbB3 monoclonal antibody — targets phenotypically distinct heregulin-positive cancer cells within solid tumors. It is designed to block heregulin-driven signaling and enhance chemotherapy’s antitumor effect.
More than 50% of patients with NSCLC are heregulin positive.
Merrimack is conducting the SHERLOC trial to evaluate seribantumab in this patient population.
The randomized, open-label, phase 2 study is designed for a target enrollment of 280 patients who will be assigned 2:1 to seribantumab plus standard pemetrexed or docetaxel, or standard therapy alone. All study participants must have failed prior treatment with three or fewer lines of therapy, including anti–PD-1 or anti–PD-L1 immunotherapy.
OS will serve as the primary endpoint. Secondary endpoints will include PFS, objective response rate, safety and quality of life.
Data are expected in 2018, according to Merrimack’s press release.
“Heregulin-positive cancer cells are characterized by their ability to escape the effects of a broad range of cancer therapies and potentially contribute to accelerated disease progression,” Akos Czibere, MD, vice president of clinical development at Merrimack, said in the release. “The SHERLOC trial is designed to advance the development of a much-needed treatment option for patients with heregulin-positive NSCLC after they progress on immunotherapies.”