Yescarta

Drug Overview

Yescarta (axicabtagene ciloleucel; Gilead) became the first chimeric antigen receptor T-cell (CAR-T) therapy to launch for the treatment of diffuse large B-cell lymphoma (DLBCL) when it gained US approval for relapsed/refractory patients in October 2017. Despite logistical challenges accompanying the manufacture of autologous T-cell therapies that limit access and contribute to the high cost of treatment, Yescarta will see strong uptake over the next decade.

Yescarta is an autologous T-cell therapy genetically engineered to express a CAR targeting cluster of differentiation (CD)19. CD19 is expressed solely on B cells; hence it is an attractive target in B-cell leukemias and B-cell lymphomas. Studies suggest a high clinical response rate of CD19 CAR-T cell-based immunotherapy in the treatment of refractory B-cell malignancies. During Yescarta therapy, the patient’s peripheral blood T lymphocytes are collected, genetically modified, and administered back in order to stimulate the patient’s own immune system to attack and kill cancer cells.

Analyst Outlook

Yescarta (axicabtagene ciloleucel; Gilead) became the first chimeric antigen receptor T-cell (CAR-T) therapy to launch for the treatment of diffuse large B-cell lymphoma (DLBCL) when it gained US approval for relapsed/refractory patients in October 2017. Despite logistical challenges accompanying the manufacture of autologous T-cell therapies that limit access and contribute to the high cost of treatment, Yescarta will see strong uptake over the next decade. In heavily pretreated patients, Yescarta treatment resulted in strong and durable response rates, as demonstrated in the ZUMA-1 trial. Furthermore, a future label expansion into the second-line setting based on the ongoing ZUMA-7 trial will increase Yescarta’s market potential in this indication. Yescarta will face direct competition over the forecast period from approved CAR-T therapy Kymriah (tisagenlecleucel; Novartis), as well as several late-phase competitors targeting the relapsed/refractory setting, including Celgene’s investigational CAR-T, lisocabtagene maraleucel.