
CHMP Positive for Breyanzi
Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
“As a company at the forefront of advancing therapies that transform outcomes for some of the most difficult-to-treat cancers, CAR T cell therapies are a significant focus of our research, and Breyanzi remains a cornerstone of our cell therapy portfolio and pipeline,” said Anne Kerber, Senior Vice President, Head of Late Clinical Development, Hematology, Oncology and Cell Therapy (HOCT), Bristol Myers Squibb. “This is another important step in our commitment to delivering Breyanzi to more patients across indications, as well as expanding into new regions, especially for diseases with continued unmet need such as relapsed or refractory FL, which is considered incurable.”
The CHMP adopted a positive opinion based on data from the global, Phase II TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL, which enrolled adults with relapsed or refractory FL treated with Breyanzi after two or more prior lines of systemic therapy. In the study, Breyanzi demonstrated a high overall response rate of 97.1% (95% CI: 91.7–99.4) and complete response rate of 94.2% (95% CI: 87.8–97.8), the study’s primary and key secondary endpoints, respectively. Responses were rapid and durable, and demonstrated sustained efficacy with 75.7% (95% CI: 66.0–83.0) of patients in response at 18 months. The safety of Breyanzi in FL is consistent with the well-established safety profile of Breyanzi observed across clinical trials, with no new safety signals observed.
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase II single-arm study to determine the efficacy and safety of Breyanzi in adult patients with relapsed or refractory indolent B-cell NHL, including FL. The primary outcome measure is overall response rate, including best overall response of complete response or partial response as determined by an Independent Review Committee. Secondary outcome measures include complete response rate, duration of response, Iprogression-free survival and safety.