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East Hanover, New Jersey, December 11, 2021 /PRNewswire/ – Novartis announces Kymriah® (Tisagenlecleucel) According to a subgroup analysis with a median follow-up of approximately 17 months in the pivotal phase II ELARA study, it is shown in high-risk patients with relapsed or refractory (r/r) follicular lymphoma (FL) Powerful curative effect1These results were announced at the oral meeting of the 63rd American Society of Hematology Annual Meeting and Exposition (ASH) (Abstract #131).
In the subgroup analysis, the results showed that Kymriah induced a high lasting response rate in most high-risk disease subgroups, and these subgroups usually had a poor prognosis.Most patients in the high-risk subgroup maintained complete response rate (CRR), overall response rate (ORR), and durability of response (DOR), with the exception of three of the nine subgroups analyzed: Progress-within two years Patients with onset (POD24), high total metabolic tumor volume (TMTV), and previous five or more lines of treatment1.
“It’s really exciting to see Kymriah treat patients with high-risk follicular lymphoma that are difficult to treat. The patients are experiencing long-term reactions with a low risk of serious adverse events,” said Catherine Tiburmont, MD, PhD, Professor of Hematology, University of Paris Seven, France Director of Hematology Oncology Department, St. Louis Hospital Paris.
A high and long-lasting response was observed in the overall population of the ELARA study. Among them, the efficacy of 94 patients was evaluable, and the median follow-up time was approximately 17 months. CRR was 69% (95% CI, 60-78), ORR was 86% (95% CI, 78-92), and 12-month progression-free survival (PFS) was 67% (95% CI, 56-76)) And the DOR at 9 months was 76% (95% CI, 65-84). For patients with complete remission (CR), the 12-month PFS was 86% (95% CI, 74-92), and the estimated DOR rate was 87% (95% CI, 75-93). In the safety analysis (n=97), the safety of Kymriah continued to reflect the significant results of the earlier ELARA analysis.Within eight weeks of the infusion, 48% of patients had cytokine release syndrome (CRS), no patients had a CRS of grade 3 or higher as defined by the Lee scale, and 37% of patients had neurological events (3% of Patients greater than or equal to 3) No treatment-related deaths1.
In the ELARA trial, a separate analysis of inpatient and intensive care unit patterns for patients treated in inpatient and outpatient settings indicated that Kymriah may reduce the utilization of medical resources for r/r FL patients treated in outpatient settings ( Abstract #3533).Among outpatients (n=17), 35% of patients do not need to be hospitalized in the first two months after the infusion; those who were infused in an inpatient setting (4 days [n=17] Compared to 12 days [n=80]).In addition, compared with inpatients, the average hospitalization cost of outpatients after infusion is much lower2.
“The ability to use Kymriah in an outpatient setting may reduce the treatment burden on patients and their care teams,” said Jeff Legos, executive vice president and global head of oncology and hematology development at Novartis. “The breadth of follicular lymphoma data available on ASH this year shows that Kymriah has the potential to provide transformative results and have a positive impact on the entire health system.”
Novartis is committed to bringing the benefits of Kymriah to more patients with advanced blood cancer around the world. Follicular lymphoma regulatory applications in the United States and the European Union have been October 2021If the indication is approved, Novartis will seek to confirm these results of the ELARA test and related analysis in a real environment.
About follicular lymphoma
Follicular lymphoma (FL), the second most common form of non-Hodgkin’s lymphoma (NHL), is an indolent lymphoma, accounting for approximately 22% of NHL cases3,4. It is usually a stubborn malignant tumor with recurrence and remission patterns5,6Throughout the lifetime of a patient with recurrent FL, he or she may receive a median of 5 lines of previous treatment, with an upper limit of 13 lines7,8Although a variety of systemic therapies are available for patients treated with FL in the third or posterior line, the efficacy of these regimens declines rapidly in the posterior line5In addition, due to this pattern of relapse and remission, patients who are ineffective to treatment or who relapse may exhaust the available treatment options5.
About the ELARA test
ELARA is a phase II, single-arm, multicenter, open-label trial designed to study the efficacy and safety of Kymriah in adult patients with r/r FL after at least two previous treatments. This international trial enrolled patients from more than 30 locations in 12 countries around the world. The primary endpoint is the complete response rate (CRR) based on the best response (Lugano 2014 criteria) reviewed by the central government. Evaluable patients have measurable disease at the time of infusion, follow-up for more than 6 months after infusion or stop the drug early. After the infusion, a disease assessment is performed every three months. In a high-risk subgroup analysis, the patients evaluated include previous hematopoietic stem cell transplantation, dual refractory disease, high follicular lymphoma, international prognosis…
The full story can be found on Benzinga.com
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