Novartis (NVS.US) neuroimmunology pipeline is a mix of good and bad news: CAR-T clinical trial suspended due to patient death, but late-stage trial of oral MS drug achieves success

Golden Ten Data APP reports that Novartis (NVS.US) is experiencing a “mixed reality” in the field of neurology and autoimmunity: the company has urgently halted eight CAR-T therapy clinical trials due to the deaths of three patients; however, its oral drug remibrutinib for multiple sclerosis (MS) has achieved positive results in late-stage clinical trials.

Urgent suspension of CAR-T trials

Novartis halted eight clinical trials of experimental therapies for autoimmune and neurological diseases at the end of August, following the deaths of three patients. This experimental therapy is known as chimeric antigen receptor T-cell immunotherapy (CAR-T). CAR-T therapy involves modifying a patient’s immune cells to recognize specific targets and destroy cancer cells.

A spokesperson for the Swiss pharmaceutical company stated that, after learning of three fatal cases caused by severe immune reactions, the company has temporarily stopped the relevant research. The specific timing of these fatalities remains unclear.

The Novartis spokesperson said the company is conducting a “comprehensive review of the observed safety events,” and described the deadly immune reaction as a known safety risk of CAR-T therapy. Novartis also noted it is cooperating with independent safety committees overseeing the suspended studies and is sharing known information with regulatory authorities.

According to reports, Bristol Myers Squibb (BMY.US) has also suspended similar CAR-T therapy trials for autoimmune diseases as a preventive measure.

Breakthrough for MS oral medication

However, Novartis has received positive news on another front. The company’s experimental oral drug for multiple sclerosis succeeded in two late-stage clinical trials and is expected to be a new oral therapy for this central nervous system autoimmune disease.

Novartis stated on Tuesday that trials showed patients treated with remibrutinib experienced fewer relapses and brain lesions compared to those treated with teriflunomide, and no liver safety signals were observed.

The medication is poised to provide Novartis with a new way to treat multiple sclerosis and may become a successor to its blockbuster Kesimpta series. This achievement also further strengthens the market outlook for BTK inhibitors, which aim to suppress harmful immune responses in the disease. Previously, comparable drugs from Sanofi and Merck failed to outperform teriflunomide in relapse rate indicators in late-stage trials. This medication may also intensify competition with Roche.

Novartis plans to submit applications worldwide for remibrutinib as a treatment for multiple sclerosis, with detailed results to be presented at a medical conference in Toronto later this year. The drug is currently approved in the US and Europe for treating chronic spontaneous urticaria, a skin condition characterized by recurrent hives.