Novartis’ CD19 CAR-T Therapy Kymriah Demonstrates 55% Five-Year Survival in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

News on June 14, 2022 /BioValleyBIOON/ -- Novartis recently announced the long-term results of the pivotal clinical study ELIANA for the CD19 CAR-T cell therapy Kymriah (tisagenlecleucel). This study is the first global CAR-T cell therapy registration study in pediatric patients, evaluating Kymriah for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.Leukemia（B-ALL）ChildrenEfficacy and safety in young adult patients, all of whom were primarily refractory, chemorefractory, postoperative relapse, or ineligible for allogeneic hematopoieticStem CellsTransplant (ASCT).The longest survival follow-up time was 5.9 years.

The final analysis of the study shows,Of the 79 patients treated with Kymriah, 55% (95% CI: 43-66) remained alive after 5 years.; Patients whose condition was alleviated within 3 months after infusion (n=65),44% were still in remission after 5 years.，The median event-free survival (EFS) was 43.8 months. These findings demonstrate the long-term benefits and curative potential of Kymriah. To date, Kymriah is the only CAR-T cell therapy available for these patient populations with limited prior treatment options.

Long-term follow-up of the ELIANA study indicates that Kymriah has the potential to transform cancer treatment for children and young adults with r/r B-ALL, significantly improving outcomes for this patient population and demonstrating durable remission and consistent safety: (1)82% (95% CI: 72-90) of patients achieved remission.(Achieving complete remission [CR] or CR with incomplete hematologic recovery [CRi] within 3 months after infusion); (2) For patients achieving remission,The 5-year recurrence-free survival (RFS) rate was 44%.(95% CI: 31-56), the median RFS was 43 months; (3) No new or unexpected adverse events were reported during the long-term follow-up.

Children's Hospital of Philadelphia CancerImmunity"These data mark a hopeful moment for children and young adults with relapsed or refractory B-cell ALL and their families, as relapse is rare after five years," said Dr. Stephan Grupp, Director of the Cell Therapy and Transplant Section. "Since Kymriah was approved nearly five years ago, we have been able to offer a truly game-changing option for a patient population that previously faced a less than 10% five-year survival rate."

Jeff Legos, Global Head and Executive Vice President of Novartis Oncology and Hematology Development, stated: "At Novartis, we are committed to curing. With nearly six years of follow-up data on these children and young adults with B-cell ALL who received treatment, we have the strongest evidence that a single Kymriah treatment has curative potential. These results reinforce our confidence in CAR-T cell therapy as a truly transformative and paradigm-shifting advancement in the field of cancer care."

Kymriah is USFDAThe First Approved CAR-T Cell Therapy, a CD19-directed genetically modified autologous T-cell immunocell therapy. Unlike conventional small molecule or biologic therapies, CAR-T cell therapy is a living T-cell treatment product. The principle of Kymriah involves genetically modifying the patient’s T-cells to express a chimeric antigen receptor (CAR) designed to target the CD19 antigen, which is a protein expressed on the surface of various hematological tumor cells, including B-cells.LymphomaAnd leukemia cells.

Kymriah is a one-time treatment designed to enhance the patient's immune system to fight cancer.To date, the approved indications for Kymriah include: (1) the treatment of pediatric and young adult patients (up to 25 years of age) with relapsed or refractory acute lymphoblastic leukemia (r/r ALL); (2) the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL); (3) the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL). (Bioon.com)

Source of the original text:Novartis five-year Kymriah® data show durable remission and long-term survival maintained in children and young adults with advanced B-cell ALL