2023-06-16 13:02:52
Important innovations in oncohematology have been presented by Kite, Gilead group companyalso at the biennial meeting International Conference on Malignant Lymphomas (Icml) ongoing in Lugano, Switzerland, through June 17, following recently announced findings at the European Hematology Association (EHA) Annual Meeting 2023 in Frankfurt and the American Society of Clinical Oncology (ASCO) Annual Meeting 2023 in Chicago. Present in 7 moments, including oral sessions, abstracts and posters at Asco, 11 at Eha, 15 at ICML – explains the company in a note – the data was eagerly awaited by the scientific community because it expands treatment options and improves the quality of life of patients with malignant lymphomas.
In detail, the Eha Congress first saw the presentation of the final analysis of the phase 2 clinical study, Alycanteconducted and sponsored by the French collaborative group Lysa/Lysarc for the use of chimeric antigen receptor therapy of cellule T (Car T) axicabtagene ciloleucel (Axi-cil) in patients with relapsed/refractory large B-cell lymphoma (Lbcl), after prior treatment, who were unable to undergo high-dose chemotherapy and autologous cell transplantation stem. The studio has satisfied its primary endpoint, with a complete metabolic response (Cmr) of 71% at 3 months compared to 12% with standard of care (based on historical controls), while 75.8% of patients showed an objective response at 3 months. At 6 months, 59.7% of the patients remained in Cmr, i.e. with a negative Pet analysis during or after the anticancer therapy. Median progression-free survival (PFS) from infusion was 11.8 months (12 months for 48.8% of patients). Median overall survival (OS) was not reached, but 12-month survival was 78.3% with an acceptable safety profile in this population.
“Patients ineligible for transplantation with aggressive lymphomas such as large B-cell lymphoma have had a poor prognosis to date,” says Stefano Luminari, full professor of medical oncology, University of Modena and Reggio Emilia, director of the research program oncohaematology of the Irccse’ a mortal stuff of Reggio Emilia – The Alycante study is the first to evaluate Car-T therapy with axi-cel as a second-line therapy for people with relapsed or refractory large B-cell lymphoma ineligible for The results showed high response rates and durable remission in these difficult-to-treat patients.”
Furthermore, “the Alycante study – adds Luminari – completes the results of the Zuma-7 study: axi-cel is the only treatment that demonstrates a statistically significant improvement compared to the second-line standard of care in large B-cell lymphoma. a median follow up of 47.2 months, Zuma 7 demonstrated a 27% reduction in the risk of death compared with standard of care. At four years, 54.6% of patients receiving axi-cil are alive compared with 46% in the comparator arm. It is important to underline – he continues – that within this arm, 57% received third-line cell therapy. These data are unprecedented in the last thirty years in the treatment of aggressive lymphomas, a news of great importance for the scientific community and for patients. This reinforces the role of Car-T therapy with axi-cil as a new standard of care in the second line of patients with large B-cell lymphoma”.
Axi-cil is the first treatment in nearly 30 years to demonstrate a significant improvement in survival in this patient population. Zuma-7 updates, presented orally at Asco2023 (abstract #LBA107) and simultaneously published in the New England Journal of Medicine, address a median follow-up of 4 years (47.2 months) of one-time treatment with axi-cil which demonstrated significantly longer overall survival compared to historical cure, with a 27.4% reduction in the risk of death – corresponding to a 38% relative improvement in overall survival – in patients with Lbcl R/R within 12 months of the completion of first-line therapy. Notably, with historical treatment, fewer than 40% of patients were able to complete their stem cell transplant, compared to 94% of patients in the Zuma-7 study who received axi-cil.
Gilead Kite also announced results from two real-world studies supporting the use of axi-cil in relapsed/refractory follicular lymphoma (abstract S223) and brexucabtagene autoleucel in mantle cell lymphoma (abstract S220). These results, presented at EHA 2023, show objective and complete response rates of 93% and 84%, respectively, similar to results from the Zuma-5 clinical trial. The estimated 6-month progression-free and overall survival were 88% and 96%, respectively, comparable to Zuma-5. Patients had a median of 4 (range 1-13) prior lines of therapy, including 14% who also had prior autologous stem cell transplantation.
Prospective data from 380 patients with relapsed/refractory mantle cell lymphoma demonstrated a 90% objective response rate, similar to Zuma-2 results, and a high complete response (78%) with brexucabtagene autoleucel. Additionally, at 12 months, the rates of duration of response, progression-free survival, and overall survival were 64%, 61%, and 74%, respectively. In a multivariate analysis of patients who had received brexucabtagene autoleucel in prior lines of therapy (1-2 vs ≥3 prior lines of therapy), data showed a 94% objective response rate and an 88% complete response rate. Multivariate analysis evaluated outcomes based on prior therapy; The results demonstrate that efficacy and safety in clinical practice in patients with relapsed or refractory large B-cell lymphoma are consistent, regardless of prior treatment.
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