Gilead's (GILD) Kite Pharma announced that the FDA has granted approval to Yescarta (axicabtagene ciloleucel or Axi-Cel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (NHL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL).
CAR T therapy is a breakthrough in hematologic cancer treatment in which a patient's own T cells are engineered to seek and destroy cancer cells. CAR T-cell therapy is manufactured specifically for each individual patient.
Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive non-Hodgkin lymphoma (NHL), accounting for three out of every five cases. In the United States each year, there are ~7,500 patients with refractory DLBCL who are eligible for CAR T therapy. Historically, when treated with the current standard of care, patients with refractory large B-cell lymphoma had a median overall survival of ~6 months, with only 7% attaining a complete response.
Currently, patients with large B-cell lymphoma in second or later lines of therapy have poor outcomes and greater unmet need, since nearly half of them either do not respond or relapse shortly after transplant. In February, Kite announced that 82% of patients in Axi-Cel's clinical trial achieved an objective response while 54% achieved a complete resopnse.
Gilead acquired Kite for $12 billion in late August just weeks after an FDA Advisory Committee gave a unanimous green light for Kite's cell therapy. Yesterday afternoon's news was essentially a forgone conclusion.
CAR-T cell therapy represents a next generation of immune-oncology medicine given the remissions seen in hematological malignancies. The holy grail for the space, however, lies in success treating solid tumors, which is a much larger market. Right now, checkpoint inhibitors from Bristol-Myers (BMY) and Merck (MRK) are the immune-oncology assets that are leading the way with solid tumors. With the $12 billion Kite acquisition, Gilead hopes to make a large, long-term splash in the competitive oncology field.