- Bristol Myers Squibb Co BMY announced the first disclosure of results from the primary analysis of the pivotal TRANSCEND CLL 004 Phase 1/2 study of Breyanzi (lisocabtagene maraleucel, liso-cel) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- At a median follow-up of 21.1 months, results show that Breyanzi delivered statistically significant complete response (CR) rates, the study's primary endpoint, in 18.4% of patients in the primary efficacy analysis set.
- Related: Bristol-Myers Squibb's Breyanzi Aces Two Lymphoma Studies On Overall Response Rate Endpoint, Plus New Collaboration.
- Among patients who achieved a CR, no disease progression or deaths were observed, with the median duration of response not reached.
- High rates of undetectable minimal residual disease (uMRD) were observed across patients treated with Breyanzi, with a uMRD rate of 63.3% in the blood and 59.2% in the bone marrow, associated with increased progression-free survival.
- The overall response rate (ORR) was 42.9%, with a median duration of response of 35.3 months.
- The company also announced the first results from the Phase 3 COMMANDS study of Reblozyl (luspatercept-aamt) versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), for anemia in adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes.
- Data showed that 58.5% of the patients treated with Reblozyl achieved transfusion independence with concurrent hemoglobin increase vs. epoetin alfa (31.2%).
- Reblozyl demonstrated a durable response, with nearly 2.5 years median transfusion independence, one year longer than epoetin alfa.
- Transfusion independence of at least 24 weeks was achieved by 47.6% of Reblozyl patients vs. 29.2% of epoetin alfa patients.
- Price Action: BMY shares are up 0.22% at $64.70 premarket on the last check Friday.
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