Bristol-Myers CAR T successful in pivotal lymphoma study, but with four deaths

Bristol-Myers Squibb (NYSE:BMY) announces positive results from a pivotal open-label Phase 1 clinical trial, TRANSCEND-NHL-001, evaluating CAR T therapy lisocabtagene maraleucel (liso-cel) (JCAR017) in patients with relapsed/refractory large B-cell lymphomas, a Breakthrough Therapy indication. The data were presented at ASH in Orlando.

The study met the primary and secondary endpoints. Specifically, the overall response rate (ORR) was 73% (n=187/256), including a 53% (n=136/256) complete response rate (primary endpoint).

Median duration of response was not reached at a median follow-up of 12 months. Median progression-free survival was 6.8 months and median overall survival was 21.1 months (secondary endpoints).

On the safety front, the most frequent serious/life-threatening/fatal treatment-related adverse events were neutropenia (60%), anemia (38%) and thrombocytopenia (27%). The incidence of any grade cytokine release syndrome (CRS) was 42% (n=113/269) with a median onset of five days post infusion. The rate of serious or higher CRS was 2% (n=6/269). The rate of neurologic events (NEs) was 30% (n=80/269), including a 10% incidence of serious or higher NEs.

There were four deaths (diffuse alveolar damage, pulmonary hemorrhage, multiple organ dysfunction syndrome or cardiomyopathy) related to liso-cel. There were three deaths (fludarabine leukoencephalopathy, septic shock and progressive multifocal leukoencephalopathy) considered unrelated to liso-cel.

The company expects to complete the filing of its U.S. marketing application this month.

#ASH19

https://seekingalpha.com/news/3524626-bristol-myers-car-t-successful-in-pivotal-nhl-study-four-deaths