Novartis’ experimental blood cancer drug CTL019 has shown positive results in a Phase II trial, positioning the company to come out on top in the race to approval for precision T-cell drugs.
The study results, presented at the American Society of Haematology (ASH) meeting, found an overall response rate at three months of 47 percent in diffuse large B-cell lymphona (DLBCL) and 73 percent in patients with follicular lymphoma (FL).
CTL019 is part of the promising new chimeric antigen receptor T cell (CART) class of therapies, which involve extracting immune system T cells from a patient then re-engineering them to find and kill cancer cells and re-infusing them back into the patient.
The were two cases of relapse in the trial – one after six months in DLBCL and one after a year in FL – as well as four cases of cytokine release syndrome (CRS), typically experience varying degrees of flu-like symptoms, and two cases of neurologic toxicities.
Nevertheless, these results put Novartis in the lead out of several companies developing CART therapies for blood cancers – which include Juno Therapeutics and Kite Pharma – and keep the company on track for its planned 2017 FDA submission.
"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," said lead investigator Dr Stephen Schuster. "We look forward to continuing this study to further understand longer-term patient response."