Bristol Myers Squibb reports positive early results from CAR T therapy trial

PRINCETON - Bristol Myers Squibb (NYSE:BMY), a prominent pharmaceutical company with $47.7 billion in annual revenue and strong gross margins of 74%, reported promising preliminary results from its Phase 1 Breakfree-1 study of an investigational CD19-targeted CAR T cell therapy for autoimmune diseases, according to a company press release. According to InvestingPro analysis, BMY maintains a robust financial health score of "GOOD," positioning it well for continued R&D investment.

The study evaluated 71 patients across three disease cohorts: systemic sclerosis, systemic lupus erythematosus, and idiopathic inflammatory myopathies. Data presented at the American College of Rheumatology Convergence 2025 showed that 94% of evaluable patients remained off chronic immunosuppressive therapy at the time of analysis.

The treatment, known as BMS-986353 (CC-97540), demonstrated an acceptable safety profile across all cohorts. Most adverse events occurred shortly after infusion and resolved quickly with standard management protocols, consistent with expected outcomes for CAR T cell therapies.

In the systemic sclerosis cohort, which included 26 treated patients, researchers observed a median 10% increase in predicted forced vital capacity at six months in subjects with interstitial lung disease. The systemic lupus erythematosus cohort showed sustained improvement in disease activity for up to 18 months.

The idiopathic inflammatory myopathies cohort, disclosed for the first time, showed that 91% of efficacy-evaluable patients achieved moderate-to-major improvement based on established response criteria. Patients also experienced substantial improvement in muscle strength. Currently trading near its 52-week low, BMY’s stock presents an interesting opportunity, with InvestingPro analysis suggesting the stock is undervalued relative to its Fair Value.

"The potential for new treatment approaches to ’reset’ a patient’s immune system, while early, is highly encouraging and provides hope for patients living with these chronic diseases," said Dr. Dinesh Khanna, Professor of Medicine and Director of the University of Michigan Scleroderma Program, as quoted in the release.

The therapy pairs the CAR construct used in BMS’s FDA-approved Breyanzi with a next-generation platform aimed at optimizing the manufacturing process. The company is currently recruiting for a Phase 2 study in systemic lupus erythematosus.

In other recent news, Bristol Myers Squibb has announced several significant developments. The company presented promising results from a global Phase I trial for iza-bren, an antibody-drug conjugate, showing a 55% confirmed response rate in patients with advanced non-small cell lung cancer. Additionally, Bristol Myers Squibb has extended its collaboration with insitro to further develop treatments for amyotrophic lateral sclerosis (ALS), potentially providing up to $20 million in new funding. In a related advancement, SystImmune received a $250 million milestone payment from Bristol Myers Squibb, triggered by the treatment of the first patient in a breast cancer study under their collaboration agreement. Furthermore, the U.S. Food and Drug Administration granted Fast Track Designation to Bristol Myers Squibb’s Alzheimer’s drug, BMS-986446, to expedite its development and review. These developments highlight Bristol Myers Squibb’s ongoing efforts in advancing treatments across various medical fields.

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