The Swiss drugmaker Novartis, one of the companies developing genetically engineered T cells to fight cancer, revealed the early results from a study on its newest therapy for two kinds of blood cancer. The study shows the overall response in adult patients with certain types of lymphoma.
Novartis tested its investigational chimeric antigen receptor T cell therapy (CTL019) in a total of 26 adults, 15 patients with diffuse large B-cell lymphoma, and 11 patients with follicular lymphoma, who have not responded to standard treatment.
The results of the study conducted by the University of Pennsylvania’s Perelman School of Medicine were shared by Novartis at the American Society of Hematology conference in Orlando on Sunday. They indicated that 47% of patients with diffuse large B-cell lymphoma and 73% of the patients with follicular lymphoma saw some reduction in cancer, at three months into treatment and three patients recorded complete responses after 6 months.
“These data add to the growing body of clinical evidence on CTL019 and illustrate its potential benefit in the treatment of relapsed and refractory non-Hodgkin lymphoma, a disease with few effective options. We look forward to continuing this study to further understand longer-term patient response.” lead investigator Stephen Schuster, M.D., Associate Professor at the University of Pennsylvania, said.
There were some relapses in the study. One partial responder in the large B-cell lymphoma group experienced disease progression after 6 months, the same happened with one patient in the follicular lymphoma group who ran into the same issue after one year.
Four other patients developed cytokine release syndrome (CRS) of grade 3 or higher. CRS is a common complication that occurs with the use of anti-T cell antibody infusions. The cytokines released by the activated T cells produce a type of systemic inflammatory response similar to those found in severe infection characterized by hypotension, pyrexia and rigors.
During CRS, patients typically experience varying degrees of flu-like symptoms with high fevers, nausea, muscle pain, and in some cases, low blood pressure and breathing difficulties. CRS has been observed after CTL019 infusion when the engineered cells become activated and multiply in the patient’s body.
Also, two other patients developed Neurologic toxicity, including one grade three episode of delirium and one possibly related grade five encephalopathy. Even though, the results give CTL019 a steady path towards 2017 regulatory submission with the U.S. Food and Drug Administration. Novartis is currently ahead of Juno Therapeutics, Kite Pharma and others that are also developing therapies for blood cancers.