Novartis Pharmaceuticals (NVS.US) neuroimmune pipeline “sad and happy”: CAR-T clinical trial suspended due to patient death, successful post-trial of MS oral medication
The Zhitong Finance App learned that Novartis Pharmaceuticals (NVS.US) ushered in a “double day of ice and fire” in the field of neurology and autoimmunity: the company urgently suspended eight clinical trials of CAR-T therapy due to the deaths of three patients; however, its multiple sclerosis (MS) oral drug remibrutinib achieved positive results in later clinical trials.
Emergency suspension of CAR-T testing
Novartis suspended eight clinical trials of experimental treatments for autoimmune and neurological diseases at the end of August after three patients died. This experimental treatment is known as chimeric antigen receptor T-cell immunotherapy (CAR-T). CAR-T therapy transforms the patient's immune cells to recognize specific targets and destroy cancer cells.
A spokesperson for the Swiss pharmaceutical company said that after learning of three cases of death due to severe immune reactions, the company temporarily suspended related research. The exact timing of these deaths is currently unknown.
A Novartis spokesperson said the company was “conducting a full review of the observed safety incidents” and described this fatal immune response as a known safety risk in CAR-T therapy. Novartis also said it is cooperating with independent safety committees that oversee various suspended studies and sharing known information with regulators.
According to reports, Bristol-Myers Squibb (BMY.US) has suspended similar trials of its CAR-T therapy in autoimmune diseases due to preventative considerations.
MS oral medicine ushered in a breakthrough
Novartis, however, favors on the other front. The experimental oral drug for multiple sclerosis developed by the company was successful in two late-stage clinical trials and is expected to become a novel oral treatment for this central nervous system autoimmune disease.
Novartis said on Tuesday that trials showed that patients treated with remibrutinib (remibrutinib) compared to patients treated with teriflunomide (teriflunomide) had reduced recurrence rates and fewer brain lesions, and no signs of liver safety were observed.
The drug is expected to provide Novartis with a novel oral medication to treat multiple sclerosis and be the successor to its blockbuster Kesimpta series. This result has also further strengthened the market prospects for BTK inhibitors, which are designed to suppress harmful immune responses in diseases. Previously, similar drugs from Sanofi and Merck failed to outperform teriflomide in terms of recurrence rate indicators in later trials. The drug may also increase competition with Roche.
Novartis plans to submit a global marketing application for remibutinib to treat multiple sclerosis. Detailed results will be announced at a medical conference in Toronto later this year. The drug is currently approved in the US and Europe to treat chronic spontaneous urticaria, a skin condition characterized by recurrent bouts.