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Msg  1120 of 3718  at  12/7/2019 2:24:02 PM  by



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Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study

Data from the pivotal liso-cel TRANSCEND NHL 001 study demonstrate patients with relapsed/refractory large B-cell lymphomas experienced high rate of durable responses
Generally manageable safety profile with low incidence of CAR T-related severe cytokine release syndrome (CRS) and neurologic events
Data presented at 2019 American Society of Hematology (ASH) Annual Meeting
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced the pivotal study of lisocabtagene maraleucel (liso-cel) an investigational CD19-directed CAR T-cell therapy with a defined composition of purified CD8+ and CD4+ CAR T cells in relapsed/refractory large B-cell lymphomas (TRANSCEND NHL 001) met its primary and secondary endpoints while demonstrating durable responses. The data were presented during an oral session at the 2019 ASH Annual Meeting in Orlando, Fla.

“Longer-term follow-up from the TRANSCEND study shows that liso-cel resulted in a rapid, high rate of durable complete responses with low incidence of severe cytokine release syndrome and neurologic events in two and ten percent, respectively, among patients with relapsed/refractory large B-cell lymphomas,” said Jeremy Abramson, M.D., Associate Professor of Medicine at Harvard Medical School and Director of the Lymphoma Center at Massachusetts General Hospital. “Additionally, responses with liso-cel were seen across patient groups including high-risk patients such as those with refractory disease, older patients and those with high tumor burden.”

In the study, 344 patients were leukapheresed and 269 patients received liso-cel at one of three dose levels (50 x 106 n=51; 100 x 106 n=177; and 150 x 106 n=41). There were 25 patients that received nonconforming product and there were two instances where product could not be manufactured. Patients were heavily pretreated and had aggressive disease with a median of three prior therapies including 35% with prior autologous or allogeneic hematopoietic stem cell transplant (HSCT) and 67% with chemotherapy-refractory disease. Bridging therapy was administered to 59% of patients.

Among patients evaluable for efficacy (n=256), the overall response rate (ORR) was 73% (187/256, 95% CI: 67 – 78) with 53% of patients (136/256, 95% CI: 47 – 59) achieving a complete response (CR). Responses were similar across all patient subgroups. The median duration of response (DOR) for all patients was not reached (95% CI: 8.6 months – NR) at a median follow-up of 12 months (95% CI: 11.2 – 16.7). Median progression-free survival (PFS) was 6.8 months (95% CI: 3.3 – 14.1) and median overall survival (OS) was 21.1 months (95% CI: 13.3 – NR). The median PFS and OS for patients who achieved a CR was not reached with 65.1% of patients progression free and 85.5% of patients alive at 12 months, respectively.

Among all patients, 79% (213/269) had grade 3 or higher treatment-emergent adverse events (TEAE) including neutropenia (60%, 161/269), anemia (38%, 101/269) and thrombocytopenia (27%, 72/269). Instances of any grade cytokine release syndrome (CRS) occurred in 42% (113/269) of patients at a median onset of 5 days and grade 3 or higher CRS occurring in 2% (6/269) of patients. There were neurologic events (NEs) that occurred in 30% of patients (80/269) with grade 3 or higher NEs occurring in 10% (27/269) of patients at a median onset of 9 days. Nineteen and 21% of patients received tocilizumab and corticosteroids, respectively. There were four grade 5 TEAEs related to liso-cel in the study from diffuse alveolar damage, pulmonary hemorrhage, multiple organ dysfunction syndrome or cardiomyopathy. There were three grade 5 TEAEs considered unrelated to liso-cel from fludarabine leukoencephalopathy, septic shock and progressive multifocal leukoencephalopathy. Eight patients had ongoing CRS/NE at the time of death from other reasons. Prolonged grade 3 or higher cytopenias were reported in 37% (100/269) of patients.

“These pivotal longer-term results from TRANSCEND NHL 001 continue to give us confidence in the clinical profile of liso-cel. Importantly, these results were demonstrated in a study with more than 250 patients in a broad population reflective of clinical practice, including those with poor prognoses and a range of histologies,” said Stanley Frankel, M.D., Senior Vice President, Cellular Therapy Development for Bristol-Myers Squibb. “We look forward to providing these data to support the regulatory approval for this treatment option for these patients with large B-cell lymphomas.”

Based on results from TRANSCEND NHL 001, Bristol-Myers Squibb expects to complete the submission of a Biologics License Application to the U.S. FDA by the end of the year.

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