The first patients, enrolled at the Loma Linda University Cancer Center, have been dosed in a Phase II clinical trial of MM-121 (also known as SAR256212), a drug candidate that targets ErbB3, a cell surface receptor, or protein attached to the cell membrane that mediates communication inside and outside the cell.
MM-121 is a fully human monoclonal antibody, a type of protein normally produced by cells of the immune system that binds to just one epitope, or chemical structure, on a protein or other structure. The investigational trial drug, MM-121, is designed to inhibit cancer growth directly, restore sensitivity to drugs to which a tumor has become resistant and delay the development of resistance of a tumor to other agents.
Merrimack partnered in 2009 with Sanofi after they initiated Phase I clinical development of this product candidate. Together, the two companies are collaborating in testing MM-121 in combination with both chemotherapies and other targeted agents across a wide spectrum of solid tumors, including lung, breast and ovarian cancers.
Lung cancer trial
The trial combines MM-121 with erlotinib (Tarceva®, Genentech), a small molecule directed at the epidermal growth factor receptor (EGFR), in three groups of patients with metastatic non-small cell lung cancer (NSCLC). The Phase II study is designed to estimate Progression Free Survival (PFS) when combining MM-121 and erlotinib in three distinct metastatic NSCLC patient populations.
No EGFR activating mutation
The first lung cancer patient population (Group A) includes patients whose tumors do not have an EGFR activating mutation. These patient's cancer must have recurred or progressed following at least one chemotherapy-containing regimen and who have not received prior EGFR targeted therapy. They will be randomized to receive either MM-121 in combination with erlotinib or erlotinib alone.
EGFR activating mutation
The second lung cancer patient population (Group B) includes patients whose tumors have an EGFR activating mutation. The patients must have not received prior EGFR targeted therapy. They will be randomized to receive either MM-121 in combination with erlotinib or erlotinib alone.
Responded to EGFR targeted therapy
The final lung cancer patient population (Group C) includes patients whose tumors had responded to EGFR targeted therapy and have subsequently acquired resistance. These will receive MM-121 in combination with erlotinib.
The study is being conducted at multiple sites in North America, Europe and Asia. The trial is designed to enroll approximately 229 patients across all three arms.
For more information:
A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NCT00994123)