Other efficacy endpoints included progression-free survival, overall survival, overall response rate and duration of response.īreyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells.
Complete response rate was a key secondary endpoint. The primary endpoint of the study was event-free survival, defined as time from randomization to death from any cause, progressive disease, failure to achieve complete response or partial response, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first.
HEMATOPOIETIC STEM CELLS PLUS
Patients were randomized to receive Breyanzi or standard of care salvage therapy, including rituximab plus dexamethasone, high-dose cytarabine, and cisplatin (R-DHAP), rituximab plus ifosfamide, carboplatin and etoposide (R-ICE), or rituximab plus gemcitabine, dexamethasone and cisplatin (R-GDP) per the investigators’ choice before proceeding to high-dose chemotherapy (HDCT) and HSCT.
HEMATOPOIETIC STEM CELLS TRIAL
TRANSFORM (NCT03575351) is a pivotal, global, randomized, multicenter Phase 3 trial evaluating Breyanzi compared to the current standard of care (platinum-based salvage chemotherapy followed by high-dose chemotherapy and hematopoietic stem cell transplant in patients responding to salvage chemotherapy) in patients with large B-cell lymphoma that was primary refractory or relapsed within 12 months after CD20-antibody and anthracycline containing first-line therapy. The decision will be applicable to all EU member states and Iceland, Norway and Liechtenstein.īristol Myers Squibb thanks the patients and investigators involved in the TRANSFORM study. In the European Union (EU), the European Commission delivers its final decision within approximately two months following receipt of the CHMP opinion. The CHMP adopted a positive opinion based on results from the pivotal phase 3 TRANSFORM study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus hematopoietic stem cell transplant (HSCT). “We look forward to continuing to work with the European Medicines Agency with the goal of bringing our cell therapy, Breyanzi, and the potential for cure to more people.” “This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant,” said Anne Kerber, senior vice president, cell therapy development, Bristol Myers Squibb.
Click hereīristol Myers Squibb gets positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory large b-cell lymphoma after one prior therapyīristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (F元B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. You can get e-magazine links on WhatsApp.
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