Kite’s cancer drug clears main study goal
Kite Pharma Inc said on Tuesday its experimental CAR T-cell therapy, which helps the immune system fight cancer, was highly effective in treating aggressive non-Hodgkin’s lymphoma, meeting the main goal of a key study.
Kite’s shares were up 15.85 percent at $65.84 after touching a more than one-year high of $69.59
CAR T-cell drugs are made by genetically altering patients’ own T-cells to add a component of antibodies that makes them better able to spot and kill cancer cells.
A number of drugmakers, including Juno Therapeutics Inc, Novartis AG and bluebird bio Inc, are testing CAR T-cell therapies, which are in various stages of development.
Non-Hodgkin’s lymphoma occurs when the body produces too many abnormal lymphocytes, a type of white blood cell. Symptoms include swollen lymph nodes, fever, night sweats, chest pain and loss of appetite.
Kite, citing an interim data from a mid-stage trial, said in September that the experimental therapy was highly effective in treating aggressive non-Hodgkin’s lymphoma, although two of the 62 trial patients died.
The company said on Tuesday that its primary analysis included all 101 patients and there were no additional deaths due to adverse events.
“Data looks very good and above expectations, demonstrating a solid risk/benefit efficacy profile that should support rapid FDA approval, possibly by the end of this year” RBC Capital Markets analyst Michael Yee said in a note.
Kite said it plans to submit a marketing application for the therapy with European regulators this year.
Jefferies analyst Biren Amin said he expected accelerated approval for the drug from the U.S. Food and Drug Administration by the end of 2017.
Bluebird’s drug, being developed in partnership with Celgene Inc, was able to induce remission in several patients with advanced multiple myeloma with no worrisome side effects in a small study.
But Juno said in November that five leukemia patients died due to severe brain swelling, raising concerns about its therapy.
“We think the results are incrementally positive for Juno and the CAR-T category more broadly as some investors have questioned the ability of CAR-T cell therapy to generate durable remissions in lymphoma,” Leerink analyst Michael Schmidt said in a note.
(Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Savio D’Souza and Maju Samuel)
Source: Reuters Health