Novartis’ CAR-T Therapy Kymriah Falls Short in Phase 3 Study
Novartis said its chimeric antigen receptor T-cell (CAR-T) therapy Kymriah (tisagenlecleucel) failed to boost survival in patients with aggressive B-cell nonHodgkin lymphoma in a phase 3 study.
The trial did not meet its primary endpoint of event-free survival for patients who had primary refractory disease or who had relapsed within a year of receiving first-line therapy, the company said.
CAR-T therapies make use of T-cells harvested from volunteers, which are then genetically altered to recognize cancer cells and inserted into patients to attack their tumors.
Kymriah was first approved by the FDA in August 2017 for treating relapsed patients with B-cell precursor acute lymphoblastic leukemia. The treatment carries an FDA boxed warning for life-threatening neurological events and cytokine release syndrome, a systemic response to the proliferation of CAR T-cells causing high fever and flu-like symptoms.